Effects of Combined rTMS and Treadmill Training in People With Parkinson's Disease
Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Completed
CT.gov ID
NCT02701647
Collaborator
(none)
51
1
3
30.9
1.6
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate whether the beneficial effect of treadmill training on people with Parkinson's disease can be enhanced by high- and low-frequency repetitive transcranial magnetic stimulation (rTMS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomised placebo-controlled trial. Fifty-one participants with Parkinson's disease (PD) will be recruited from the Hong Kong PD association, a self-help group and movement disorders clinic of 3 local hospitals. Written informed consent in accordance with the Declaration of Helsinki will be obtained from all participants. Eligible participants will be randomly assigned into one of the three groups: 1Hz-TT, 25Hz-TT, and sham-TT upon recruitment. Randomisation will be generated by a computer program and group assignment will be blinded to both participants and assessor. Participant will receive either 1-Hz, 25-Hz, or sham rTMS which will last for about 20 minutes followed by 30 minutes treadmill walking training for 12 sessions, 4 times per week for 3 weeks. All assessments will be conducted 1 week before intervention and 1 day after completion of intervention, after 1-month training and at 3-month post training.
The sample size calculation is based on the significant findings of the gait speed reported by Yang et al (2013). A two-way repeated measures ANOVA design with between-subject group effect (3 levels) and within-subject time effect (4 levels) determines that 15 subjects per group are required to achieve 85% power to test the interaction effect between groups and time effect with a 5% significance level and the effect size is 0.2. By assuming 10% dropout rate, 17 subjects will be required per group.
Study Design
Study Type:
Interventional
Actual Enrollment
:
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Repetitive Transcranial Magnetic Stimulation Promotes Gait Training in People With Parkinson's Disease - a Randomised Controlled Trial
Actual Study Start Date
:
Oct 1, 2016
Actual Primary Completion Date
:
Dec 1, 2018
Actual Study Completion Date
:
May 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 25Hz-TT Participants will receive 4s train of 25-Hz rTMS pulses with 50s inter-train interval, with an intensity of 80% resting motor threshold (RMT). Participant will receive a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. |
Device: Repetitive transcranial magnetic stimulation (rTMS)
Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.
Other: Treadmill training
Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. 80% of participant's over ground maximum walking speed will be halved and used for warm-up. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. Progression will be given if patients could tolerate the belt speed with appropriate step length and walk with good stability for 5 minutes. Participants will maintain the maximum speed achieved for the rest of the session or adjusted as needed. Positive verbal feedback will be given to encourage large strides and upright posture during training. The participants will be instructed to walk on treadmill without holding onto the handrails if possible. Participants will perform warm up and cool down exercise to minimize training related-injury.
|
| Experimental: 1Hz-TT Participants will receive a total of 600 1-Hz rTMS pulses in 10 minutes for each hemisphere and a total of 1200 pulses ,with an intensity of 80% RMT, followed by 30 minutes of treadmill training. |
Device: Repetitive transcranial magnetic stimulation (rTMS)
Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.
Other: Treadmill training
Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. 80% of participant's over ground maximum walking speed will be halved and used for warm-up. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. Progression will be given if patients could tolerate the belt speed with appropriate step length and walk with good stability for 5 minutes. Participants will maintain the maximum speed achieved for the rest of the session or adjusted as needed. Positive verbal feedback will be given to encourage large strides and upright posture during training. The participants will be instructed to walk on treadmill without holding onto the handrails if possible. Participants will perform warm up and cool down exercise to minimize training related-injury.
|
| Sham Comparator: Sham-TT Sham rTMS will be applied over the same site as for real rTMS, however, with the cable of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as per 25Hz-TT group will be placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training. |
Device: Repetitive transcranial magnetic stimulation (rTMS)
Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.
Other: Treadmill training
Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. 80% of participant's over ground maximum walking speed will be halved and used for warm-up. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. Progression will be given if patients could tolerate the belt speed with appropriate step length and walk with good stability for 5 minutes. Participants will maintain the maximum speed achieved for the rest of the session or adjusted as needed. Positive verbal feedback will be given to encourage large strides and upright posture during training. The participants will be instructed to walk on treadmill without holding onto the handrails if possible. Participants will perform warm up and cool down exercise to minimize training related-injury.
|
Outcome Measures
Primary Outcome Measures
- Fastest Walking Speed [Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention]
Each participant is instructed to walk for 14 meters at their fastest walking speed for three trials. The time taken for the middle 10 meter was recorded. The average of three trials is used for analysis.
Secondary Outcome Measures
- Timed-Up-and-Go Test (iTUG) [Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention]
Participants are instructed to stand up from a chair and walk for 7 meters walkway and return back to the chair turn around and sit down. Time and gait parameters during TUG were captured by the valid and reliable APDM system, which is a wearable gait and balance analysis system.
- the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) [Baseline, I day post-intervention, 1 month post-intervention and 3 months post-intervention]
MDS-UPDRS III is a valid and reliable clinical test, will be used to evaluate severity of motor symptoms of PD. There are total of 27 items including tremor, rigidity, bradykinesia, postural instability and gait performance. Each item scores from 0-4, with 0 indicates no disability and 4 maximum disabled with total score(s) ranges from 0 to 132.
- Walking Distance in a 2 -Minute Walk Test [Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention]
The 2 minute walk test will be conducted along a 20 m x 2 m hallway. A line is marked at each end of the walkway to indicate where the person is to turn. Participants will be instructed to " walk as far as possible in 2 minutes". They will be given standardised encouragement at 60 and 90 seconds during walk. Distance walked will be recorded to the nearest meter.
- Mini Balance Evaluation Systems Test Scores [Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention]
Balance performance of participants will be assessed in 4 domains namely anticipatory postural adjustments, postural responses, sensory orientation and gait stability. Each item is rated from 0-2 with a total scores of 28. The Total scores range from 0-28, with higher scores indicate better dynamic balance.
- Dual-task Timed-Up-and-Go Test (DT-TUG) [Baseline, 1 day post-intervention, 1 month post-intervention, 3 month-post intervention]
For DT-TUG, participants were instructured to repeat the TUG procedure while performing a serial three substraction. Time taken to complete DT-TUG and accuracy of digital counting was recorded. One practice trial was given prior to both TUG and DT-TUG testing and average performance of three trials was used for analysis.
Other Outcome Measures
- Cortical Silent Period [Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention]
Ten suprathreshold TMS stimuli (i.e. 130% RMT) will be delivered while participant performing a 20% isometric maximal contraction of Tibialis Anterior of the more affected side. Cortical silent period (CSP) measures the duration of interruption of electromyography (EMG) activity in the contracting muscle produced by TMS. CSP duration will be determined as the period between the onset of MEP and the return of baseline EMG activity measured 50 ms before the TMS stimulus.
- Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve) [Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention]
TMS stimuli will be applied at 10% steps between 100% to 160% RMT. 10 stimuli will be delivered at each intensity. Peak to peak amplitude of 10 motor-evoked potentials (MEPs) at each stimulus intensity will be averaged offline.The cut-off intensity is set at 75% of maximum stimulator output due to discomfort perceived by majority of the participants. MEPs will be normalised with the maximal muscle action potential (MMax), which is determined by supramaximal electrical stimulation of the fibular nerve. A scatter graph will be generated with the average amplitude of MEPs as a function of stimulation intensity. The linear trend will be added to generate the linear recruitment curve slope.
- Short-interval-intracortical Inhibition [Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention]
Short-interval-intracortical inhibition (SICI) is another measure of cortical inhibition. In a paired- pulse TMS paradigm, a test pulse will be adjusted to produce MEP of at least 0.5 millivolts which will be delivered preceded by a brief conditioned pulse set at a lower intensity of 80% RMT with inter-stimulus interval of 2 milliseconds. Two stimulators connected via a Bistim module ( Magstim Co.,Whitland, UK) will be used in this test. Ten conditioned MEPs and unconditioned MEPs will be obtained in a random order and were averaged for each condition. SICI is expressed as percentage of unconditioned test MEP amplitude.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosed with idiopathic Parkinson's disease by a neurologist
-
had been stable on anti-Parkinsonian medication
-
able to walk independently for 30 meters
Exclusion Criteria:
-
severe co-morbidity that may interfere with their ability to participate including significant orthopaedic or rheumatological conditions or disorders of peripheral nervous systems that may interfere with mobility or balance performance
-
a diagnosis of neurological disease other than PD
-
a history of psychiatric disorders
-
the impossibility of inducing motor evoked potentials (MEPs)
-
a score of less than 24 on the Mini-Mental State Examination
-
contraindication to TMS including personal or family history of seizure disorder, metal in the head, implants of medical devices such as cardiac pacemakers or medical pumps, females subjects who are pregnant, a history of neurosurgery
-
subjects with irrepressible tremor and / or dyskinesia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rehabilitation Sciences | Hong Kong | Hong Kong | 852 |
Sponsors and Collaborators
- The Hong Kong Polytechnic University
Investigators
- Principal Investigator: Margaret Mak, PhD, The Hong Kong Polytechnic University
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT02701647
Other Study ID Numbers:
- HSEARS20140423002
First Posted:
Mar 8, 2016
Last Update Posted:
Nov 22, 2019
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by The Hong Kong Polytechnic University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS |
|---|---|---|---|
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. |
| Period Title: Overall Study | |||
| STARTED | 17 | 17 | 17 |
| COMPLETED | 17 | 17 | 16 |
| NOT COMPLETED | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. 80% of participant's over ground maximum walking speed will be halved and used for warm-up. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. Progression will be given if patients could tolerate the belt speed with appropriate step length and walk with good stability for 5 minutes. Maximum achieved speed will be maintained followed by 0.5 km/h decrements. Participants will maintain the rest of the treadmill session with this speed or further adjustment will be made if participants are unable to maintain. Positive verbal feedback | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group will be placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Total of all reporting groups |
| Overall Participants | 17 | 17 | 16 | 50 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
13
76.5%
|
11
64.7%
|
11
68.8%
|
35
70%
|
| >=65 years |
4
23.5%
|
6
35.3%
|
5
31.3%
|
15
30%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
62.7
(6.8)
|
62.1
(5.7)
|
62.1
(5.7)
|
62.3
(6.0)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
7
41.2%
|
8
47.1%
|
9
56.3%
|
24
48%
|
| Male |
10
58.8%
|
9
52.9%
|
7
43.8%
|
26
52%
|
| Race and Ethnicity Not Collected (Count of Participants) | ||||
| Count of Participants [Participants] |
0
0%
|
|||
| Region of Enrollment (participants) [Number] | ||||
| Hong Kong |
17
100%
|
17
100%
|
16
100%
|
50
100%
|
| Disease duration (no. of years of diagnosis of PD) (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
5.2
(3.4)
|
7.5
(4.9)
|
6.9
(3.3)
|
6.5
(4.0)
|
| daily levodopa equivalent dose (mg/day) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/day] |
484.2
(336.4)
|
512.5
(359.9)
|
493.3
(523.9)
|
496.8
(404.2)
|
Outcome Measures
| Title | Fastest Walking Speed |
|---|---|
| Description | Each participant is instructed to walk for 14 meters at their fastest walking speed for three trials. The time taken for the middle 10 meter was recorded. The average of three trials is used for analysis. |
| Time Frame | Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS |
|---|---|---|---|
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. | Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training. |
| Measure Participants | 17 | 17 | 16 |
| Baseline |
149.5
(24.7)
|
153.1
(27.3)
|
156.1
(30.2)
|
| 1 day Post intervention |
164.3
(26.3)
|
167.3
(34.0)
|
160.7
(33.3)
|
| 1 month post intervention |
167.8
(26.4)
|
170.6
(35.6)
|
164.6
(32.3)
|
| 3 month post intervention |
163.2
(31.0)
|
169.9
(38.7)
|
156.7
(28.0)
|
| Title | Timed-Up-and-Go Test (iTUG) |
|---|---|
| Description | Participants are instructed to stand up from a chair and walk for 7 meters walkway and return back to the chair turn around and sit down. Time and gait parameters during TUG were captured by the valid and reliable APDM system, which is a wearable gait and balance analysis system. |
| Time Frame | Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 25Hz-TT | 1Hz-TT | Sham-TT |
|---|---|---|---|
| Arm/Group Description | Participants will receive 4s train of 25-Hz rTMS pulses with 50s inter-train interval, with an intensity of 80% resting motor threshold (RMT). Participant will receive a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. | Participants will receive a total of 600 1-Hz rTMS pulses in 10 minutes for each hemisphere and a total of 1200 pulses ,with an intensity of 80% RMT, followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. | Sham rTMS will be applied over the same site as for real rTMS discounnted coil. Anothe coil using the same stimulation parameters as per 25Hz-TT group will be placed posterior to the subject's neck produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. |
| Measure Participants | 17 | 17 | 16 |
| Baseline |
20.8
(4.0)
|
18.3
(2.5)
|
19.3
(2.5)
|
| 1 day Post intervention |
18.4
(2.8)
|
17.1
(2.7)
|
18.0
(2.1)
|
| 1 month post intervention |
17.7
(2.9)
|
17.1
(2.3)
|
17.9
(1.8)
|
| 3 month post intervention |
17.9
(2.8)
|
16.6
(2.3)
|
18.4
(2.1)
|
| Title | the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) |
|---|---|
| Description | MDS-UPDRS III is a valid and reliable clinical test, will be used to evaluate severity of motor symptoms of PD. There are total of 27 items including tremor, rigidity, bradykinesia, postural instability and gait performance. Each item scores from 0-4, with 0 indicates no disability and 4 maximum disabled with total score(s) ranges from 0 to 132. |
| Time Frame | Baseline, I day post-intervention, 1 month post-intervention and 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS |
|---|---|---|---|
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. |
| Measure Participants | 17 | 17 | 16 |
| Baseline |
27.9
(10.5)
|
27.1
(9.6)
|
29.7
(10.6)
|
| 1 day Post intervention |
19.9
(8.5)
|
22.2
(7.5)
|
27.9
(9.0)
|
| 1 month post intervention |
20.8
(8.9)
|
22.5
(7.3)
|
27.9
(10.1)
|
| 3 month post intervention |
22.5
(10.1)
|
21.9
(7.8)
|
27.3
(8.0)
|
| Title | Walking Distance in a 2 -Minute Walk Test |
|---|---|
| Description | The 2 minute walk test will be conducted along a 20 m x 2 m hallway. A line is marked at each end of the walkway to indicate where the person is to turn. Participants will be instructed to " walk as far as possible in 2 minutes". They will be given standardised encouragement at 60 and 90 seconds during walk. Distance walked will be recorded to the nearest meter. |
| Time Frame | Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 25Hz-TT | 1Hz-TT | Sham-TT |
|---|---|---|---|
| Arm/Group Description | Participants will receive 4s train of 25-Hz rTMS pulses with 50s inter-train interval, with an intensity of 80% resting motor threshold (RMT). Participant will receive a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. | Participants will receive a total of 600 1-Hz rTMS pulses in 10 minutes for each hemisphere and a total of 1200 pulses ,with an intensity of 80% RMT, followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. | Sham rTMS will be applied over the same site as for real rTMS discounnted coil. Anothe coil using the same stimulation parameters as per 25Hz-TT group will be placed posterior to the subject's neck produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. |
| Measure Participants | 17 | 17 | 16 |
| Baseline |
147.4
(29.8)
|
144.7
(31.3)
|
148.7
(25.0)
|
| 1 day post intervention |
160.4
(28.0)
|
164.9
(29.8)
|
157.3
(31.7)
|
| 1 month post intervention |
166.3
(29.7)
|
167.9
(29.7)
|
157.9
(29.7)
|
| 3 month post intervention |
163.1
(30.7)
|
166.8
(31.2)
|
160.5
(28.9)
|
| Title | Mini Balance Evaluation Systems Test Scores |
|---|---|
| Description | Balance performance of participants will be assessed in 4 domains namely anticipatory postural adjustments, postural responses, sensory orientation and gait stability. Each item is rated from 0-2 with a total scores of 28. The Total scores range from 0-28, with higher scores indicate better dynamic balance. |
| Time Frame | Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 25Hz-TT | 1Hz-TT | Sham-TT |
|---|---|---|---|
| Arm/Group Description | Participants will receive 4s train of 25-Hz rTMS pulses with 50s inter-train interval, with an intensity of 80% resting motor threshold (RMT). Participant will receive a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. | Participants will receive a total of 600 1-Hz rTMS pulses in 10 minutes for each hemisphere and a total of 1200 pulses ,with an intensity of 80% RMT, followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. | Sham rTMS will be applied over the same site as for real rTMS discounnted coil. Anothe coil using the same stimulation parameters as per 25Hz-TT group will be placed posterior to the subject's neck produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training. Repetitive transcranial magnetic stimulation (rTMS): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil. Treadmill training: Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. |
| Measure Participants | 17 | 17 | 16 |
| Baseline |
21.5
(3.4)
|
21.8
(2.7)
|
21.7
(2.8)
|
| 1 day post intervention |
24.2
(2.5)
|
23.8
(2.7)
|
22.4
(2.2)
|
| 1 month post intervention |
23.8
(2.8)
|
23.5
(2.5)
|
22.8
(2.5)
|
| 3 month post intervention |
23.4
(3.0)
|
24.1
(2.6)
|
23.0
(2.4)
|
| Title | Dual-task Timed-Up-and-Go Test (DT-TUG) |
|---|---|
| Description | For DT-TUG, participants were instructured to repeat the TUG procedure while performing a serial three substraction. Time taken to complete DT-TUG and accuracy of digital counting was recorded. One practice trial was given prior to both TUG and DT-TUG testing and average performance of three trials was used for analysis. |
| Time Frame | Baseline, 1 day post-intervention, 1 month post-intervention, 3 month-post intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS |
|---|---|---|---|
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. |
| Measure Participants | 17 | 17 | 16 |
| Baseline |
27.9
(8.8)
|
24.0
(7.0)
|
25.5
(5.6)
|
| 1 day Post intervention |
23.1
(5.6)
|
21.1
(5.2)
|
23.4
(4.0)
|
| 1 month post intervention |
21.8
(6.0)
|
20.6
(4.7)
|
23.9
(3.9)
|
| 3 month post intervention |
22.3
(6.0)
|
20.3
(4.6)
|
23.9
(3.9)
|
| Title | Cortical Silent Period |
|---|---|
| Description | Ten suprathreshold TMS stimuli (i.e. 130% RMT) will be delivered while participant performing a 20% isometric maximal contraction of Tibialis Anterior of the more affected side. Cortical silent period (CSP) measures the duration of interruption of electromyography (EMG) activity in the contracting muscle produced by TMS. CSP duration will be determined as the period between the onset of MEP and the return of baseline EMG activity measured 50 ms before the TMS stimulus. |
| Time Frame | Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| 1 discarded data due to poor quality of data |
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS |
|---|---|---|---|
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. |
| Measure Participants | 17 | 17 | 15 |
| Baseline |
176.5
(50.0)
|
164.6
(39.8)
|
183.9
(38.9)
|
| 1 day Post intervention |
194.4
(53.2)
|
180.6
(39.1)
|
175.1
(46.6)
|
| 1 month post intervention |
190.1
(54.5)
|
160.1
(41.1)
|
189.2
(37.6)
|
| 3 month post intervention |
175.9
(43.2)
|
154.6
(46.0)
|
182.9
(35.0)
|
| Title | Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve) |
|---|---|
| Description | TMS stimuli will be applied at 10% steps between 100% to 160% RMT. 10 stimuli will be delivered at each intensity. Peak to peak amplitude of 10 motor-evoked potentials (MEPs) at each stimulus intensity will be averaged offline.The cut-off intensity is set at 75% of maximum stimulator output due to discomfort perceived by majority of the participants. MEPs will be normalised with the maximal muscle action potential (MMax), which is determined by supramaximal electrical stimulation of the fibular nerve. A scatter graph will be generated with the average amplitude of MEPs as a function of stimulation intensity. The linear trend will be added to generate the linear recruitment curve slope. |
| Time Frame | Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 sets of discarded data due to poor quality |
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS |
|---|---|---|---|
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. |
| Measure Participants | 17 | 16 | 15 |
| Baseline |
0.51
(0.30)
|
0.53
(0.39)
|
0.61
(0.32)
|
| 1 day Post intervention |
0.58
(0.36)
|
0.64
(0.37)
|
0.52
(0.40)
|
| 1 month post intervention |
0.70
(0.57)
|
0.63
(0.30)
|
0.59
(0.43)
|
| 3 month post intervention |
0.74
(0.47)
|
0.70
(0.41)
|
0.58
(0.45)
|
| Title | Short-interval-intracortical Inhibition |
|---|---|
| Description | Short-interval-intracortical inhibition (SICI) is another measure of cortical inhibition. In a paired- pulse TMS paradigm, a test pulse will be adjusted to produce MEP of at least 0.5 millivolts which will be delivered preceded by a brief conditioned pulse set at a lower intensity of 80% RMT with inter-stimulus interval of 2 milliseconds. Two stimulators connected via a Bistim module ( Magstim Co.,Whitland, UK) will be used in this test. Ten conditioned MEPs and unconditioned MEPs will be obtained in a random order and were averaged for each condition. SICI is expressed as percentage of unconditioned test MEP amplitude. |
| Time Frame | Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| unable to perform procedure due to small MEPS values for 5 participants |
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS |
|---|---|---|---|
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. | Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training. Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed. |
| Measure Participants | 15 | 14 | 11 |
| Baseline |
56.4
(27.0)
|
49.4
(24.1)
|
62.2
(33.1)
|
| 1 day Post intervention |
44.4
(23.0)
|
51.4
(28.2)
|
76.5
(49.8)
|
| 1 month post intervention |
42.0
(26.9)
|
62.6
(31.7)
|
89.8
(62.9)
|
| 3 month post intervention |
50.8
(22.8)
|
60.7
(39.2)
|
74.3
(30.2)
|
Adverse Events
| Time Frame | during intervention, at 1 day post-intervention,1 month post-intervention and at 3 month post-intervention | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | 25-Hz rTMS | 1-Hz rTMS | Sham rTMS | |||
| Arm/Group Description | Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. | Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training. | Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training. | |||
All Cause Mortality |
||||||
| 25-Hz rTMS | 1-Hz rTMS | Sham rTMS | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | 0/17 (0%) | 0/16 (0%) | |||
Serious Adverse Events |
||||||
| 25-Hz rTMS | 1-Hz rTMS | Sham rTMS | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | 0/17 (0%) | 0/16 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| 25-Hz rTMS | 1-Hz rTMS | Sham rTMS | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | 0/17 (0%) | 0/16 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Chloe Chung |
|---|---|
| Organization | The Hong Kong Polytechnic University |
| Phone | 2766 ext 7092 |
| chloe.lh.chung@connect.polyu.hk |
Responsible Party:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT02701647
Other Study ID Numbers:
- HSEARS20140423002
First Posted:
Mar 8, 2016
Last Update Posted:
Nov 22, 2019
Last Verified:
Jun 1, 2018