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Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01745952
Collaborator
(none)
11
Enrollment
1
Location
3
Arms
37
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will treat patients with fully characterized refractory unifocal neocortical epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the epilepsy. Active rTMS applied over the epileptogenic focus will reduce seizure frequency compared with sham rTMS.

Condition or Disease Intervention/Treatment Phase
  • Device: figure-of-eight active rTMS coil
  • Device: round active rTMS coil
  • Device: sham rTMS coil (figure-of-eight)
 N/A

Detailed Description

  1. Background and study aims

Epilepsy is a disease that causes repetitive seizures. In 60% of people with epilepsy, these seizures start in a small zone of the brain (focal or partial epilepsy). This zone can be in the depth of the temporal lobe (mesial temporal lobe epilepsy) or in another brain region (neocortical epilepsy). Even with optimal medical care, up to 30% of people with epilepsy continue to have seizures.

The investigators will treat people with neocortical partial epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the epilepsy. The investigators have good reasons to believe that there will be fewer seizures during several weeks after treatment.

  1. Who can participate?

You have neocortical focal epilepsy. A doctor who specializes in epilepsy made this diagnosis. You had at least one seizure recorded while in an epilepsy monitoring unit. You had an MRI scan of the brain. You can deliver us all the results of the tests you had.

You continue to have more than 4 seizures a month. You tried a least two different schemes of anti-epileptic drugs as prescribed by your doctor and those schemes were well tolerated. Nevertheless this never cured the seizures.

You are older than 16 years. You don't plan to become pregnant during the study. You need to faithfully continue your treatment as prescribed by your doctor and don't change the drugs you take from at least 4 weeks before the study until 8 weeks after the last TMS session. You need to be able to keep a diary of your seizures.

  1. What does the study involve?

You will need to come to the hospital every weekday during two consecutive weeks, every three months during nine months for the TMS-treatment. So you will have three treatment sessions. You will have a brain scan (FDG-PET) before the first treatment and after each session.

The magnetic pulses will be delivered differently during each of the three treatment sessions: once on a rather small area of the brain, once on a larger brain area and once using a dummy coil, i.e. you will have two active treatment sessions and one dummy or placebo session. The investigators will not tell in which order they deliver the treatments.

  1. What are the possible benefits and risks of participating?

The investigators have good reasons to believe you will have fewer seizures in the weeks following the active treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multimodal Image-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Refractory Partial Epilepsy.
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: figure-of-eight active rTMS coil

rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.

Device: figure-of-eight active rTMS coil
navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil
Experimental: round active rTMS coil

rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.

Device: round active rTMS coil
navigated rTMS over epileptogenic focus using round active rTMS coil
Sham Comparator: sham rTMS coil (figure-of-eight)

rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.

Device: sham rTMS coil (figure-of-eight)
commercially available placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue

Outcome Measures

Primary Outcome Measures

  1. 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment [week 12 after each intervention]

    Number of participants achieving a 50% or greater reduction in seizure frequency from baseline

Secondary Outcome Measures

  1. Seizure Frequency After Active rTMS Treatment Compared With Placebo Treatment [week 12 after each treatment]

    Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.

Other Outcome Measures

  1. Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level [within one week after the last treatment day of each session]

    Alterations were assessed by visual inspection of PET scans generated by subtracting the baseline individual PET scan from each of the follow-up scans. The subtraction PET scans were overlayed on the anatomical MRI of the patient and the focus of stimulation determined and an sphere with a 1cm radius around this point was analysed.

  2. Difference in Seizure Reduction Using Different Coil Types [9 months]

    any difference between the four conditions (baseline/ figure-of-eight treatment/ round coil treatment/ sham treatment) based in negative binomial model for count data

  3. Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale [before the first treatment of each session and at the last evaluation visit]

    Quality of life in epilepsy (QOLIE-31): self-report (if cognitive faculties allowed) questionnaire of emotional well-being, social functioning, energy/ fatigue, cognitive functioning, seizure worry, medication effects & overall quality of life. Range 0-100, with higher numbers indicating better quality of life. Global impression of change-scales (score 1-7, with 4 no change and lower/higher numbers implying grade of improvement/worsening) and Visual analogue scale (0-10: no problem to horrible): self-report or parent report about effect of treatment Columbia Suicide Severity Rating Scale (CSSR): structured interview about suicidal risk change in QOLIE scores considered better/worse are based on cut-off reported in "DOI 10.1016/j.yebeh.2011.12.023" For global impression of change, the scoring was <4, 4 or >4.

  4. Drop Out-rate [during the 9 months of the study]

    exclusion by investigator was due to necessity to change drug regimen due to toxicity

  5. Adverse Event Rate [during the 9 months of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • fully characterized refractory unifocal neocortical epilepsy (i.e. the epileptogenic zone is well defined)

  • on a stable drug regimen for at least one month,

  • able to complete a seizure dairy either by the patient or by a significant other

Exclusion Criteria:

  • Metal in the head including deep brain stimulators, aneurysmal clips, ventricular shunts, cochlear implants, ossicular reconstruction of the middle ear…

  • pacemaker, implantable cardioverter-defibrillator (ICD)

  • psychogenic non-epileptic seizures and other non-epileptic spells

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven, department of Neurology Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

  • Principal Investigator: Van Paesschen Wim, MD, PhD, Universitaire Ziekenhuizen Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01745952
Other Study ID Numbers:
  • s52486
First Posted:
Dec 10, 2012
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Universitaire Ziekenhuizen Leuven
Epilepsies, Partial
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Figure-of-eight Active Coil; Then Round Active Coil; Then Sham Round Active Coil; Then Sham; Then Figure-of-eight Active Coil Sham Coil; Then Figure-of-eight Active Coil; Then Round Active
Arm/Group Description rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period
Period Title: Overall Study
STARTED 4 4 3
COMPLETED 3 3 3
NOT COMPLETED 1 1 0

Baseline Characteristics

Arm/Group Title All Participants
Arm/Group Description description of the patients at the onset of the study
Overall Participants 11
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
11
100%
>=65 years
0
0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
35
Sex: Female, Male (Count of Participants)
Female
7
63.6%
Male
4
36.4%
baseline seizure frequency per week (seizures/week) [Mean (Full Range) ]
Mean (Full Range) [seizures/week]
24.9

Outcome Measures

1. Primary Outcome
Title 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment
Description Number of participants achieving a 50% or greater reduction in seizure frequency from baseline
Time Frame week 12 after each intervention

Outcome Measure Data

Analysis Population Description
Besides the reported participants that went through whole protocol, one supplementary participant underwent the first rTMS session of the first protocol and one supplementary participant underwent the first rTMS session of the second protocol
Arm/Group Title Figure-of-eight Active Coil; Then Round Active Coil; Then Sham Round Active Coil; Then Sham; Then Figure-of-eight Active Coil Sham Coil; Then Figure-of-eight Active Coil; Then Round Active
Arm/Group Description rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period
Measure Participants 3 2 3
50% seizure reduction over any of three periods
0
0%
0
NaN
0
NaN
50% seizure reduction over whole study
0
0%
0
NaN
0
NaN
2. Secondary Outcome
Title Seizure Frequency After Active rTMS Treatment Compared With Placebo Treatment
Description Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.
Time Frame week 12 after each treatment

Outcome Measure Data

Analysis Population Description
baseline weekly seizure frequency over all participants was 24.8 (95% confidence interval 8.2-76.1)
Arm/Group Title Figure-of-eight Active rTMS Coil Round Active rTMS Coil Sham rTMS Coil (Figure-of-eight)
Arm/Group Description rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered. rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered
Measure Participants 8 9 7
Mean (95% Confidence Interval) [seizures/week]
25.7
23.5
28.6
3. Other Pre-specified Outcome
Title Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level
Description Alterations were assessed by visual inspection of PET scans generated by subtracting the baseline individual PET scan from each of the follow-up scans. The subtraction PET scans were overlayed on the anatomical MRI of the patient and the focus of stimulation determined and an sphere with a 1cm radius around this point was analysed.
Time Frame within one week after the last treatment day of each session

Outcome Measure Data

Analysis Population Description
patients of whom seizure journals were incomplete also included (one participant who went through all 3 trials and one patient of whom journals were not available from the sham session, that was reported by the patient as "ineffective")
Arm/Group Title Figure-of-eight Active rTMS Coil Round Active rTMS Coil Sham rTMS Coil (Figure-of-eight)
Arm/Group Description rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered. rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered. rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered.
Measure Participants 9 10 9
hypermetabolism compared to baseline
1
9.1%
3
NaN
2
NaN
hypometabolism compared to baseline
3
27.3%
3
NaN
3
NaN
4. Other Pre-specified Outcome
Title Difference in Seizure Reduction Using Different Coil Types
Description any difference between the four conditions (baseline/ figure-of-eight treatment/ round coil treatment/ sham treatment) based in negative binomial model for count data
Time Frame 9 months

Outcome Measure Data

Analysis Population Description
averaged weekly seizure count per condition is given for all patients combined
Arm/Group Title Any Difference Between the Four Conditions
Arm/Group Description effect of baseline/ figure-of-eight/ round/ sham treatment period on the seizure frequency of the patients
Measure Participants 10
seizures in condition 1 (baseline)
25
seizures in condition 2 (figure-8)
26
seizures in condition 3 (round)
24
seizures in condition 4 (sham)
29
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Figure-of-eight Active Coil; Then Round Active Coil; Then Sham
Comments
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.9819
Comments
Method negative binomial model + overdispersion
Comments
5. Other Pre-specified Outcome
Title Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale
Description Quality of life in epilepsy (QOLIE-31): self-report (if cognitive faculties allowed) questionnaire of emotional well-being, social functioning, energy/ fatigue, cognitive functioning, seizure worry, medication effects & overall quality of life. Range 0-100, with higher numbers indicating better quality of life. Global impression of change-scales (score 1-7, with 4 no change and lower/higher numbers implying grade of improvement/worsening) and Visual analogue scale (0-10: no problem to horrible): self-report or parent report about effect of treatment Columbia Suicide Severity Rating Scale (CSSR): structured interview about suicidal risk change in QOLIE scores considered better/worse are based on cut-off reported in "DOI 10.1016/j.yebeh.2011.12.023" For global impression of change, the scoring was <4, 4 or >4.
Time Frame before the first treatment of each session and at the last evaluation visit

Outcome Measure Data

Analysis Population Description
* Self-reporting questionnaires could only be filled in by 7 participants For global impression of change scales, the score reached by consensus between the patient and caregiver(s) was used if patient was unable to fill in questionaires: for the three arms, we thus have 7/8/6 scores for each arm respectively
Arm/Group Title Figure-of-eight Active rTMS Coil Round Active rTMS Coil Sham rTMS Coil (Figure-of-eight)
Arm/Group Description rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered. rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered. rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered.
Measure Participants 5 6 5
better QOLIE score
3
27.3%
3
NaN
1
NaN
worse QOLIE score
0
0%
1
NaN
1
NaN
Global impression of change: no change
4
36.4%
5
NaN
5
NaN
Global impression of change: worse
1
9.1%
1
NaN
1
NaN
Global impression of change: better
1
9.1%
1
NaN
0
NaN
Global impression change: first better, then worse
1
9.1%
1
NaN
0
NaN
CSSR-scale increased suicidality
0
0%
0
NaN
0
NaN
6. Other Pre-specified Outcome
Title Drop Out-rate
Description exclusion by investigator was due to necessity to change drug regimen due to toxicity
Time Frame during the 9 months of the study

Outcome Measure Data

Analysis Population Description
for this analysis, all patients randomised were included; this includes one patient in the second arm that was not included in any of the other outcome measures, due to lack of reliable outcome parameters
Arm/Group Title Figure-of-eight Active Coil; Then Round Active Coil; Then Sham Round Active Coil; Then Sham; Then Figure-of-eight Active Coil Sham Coil; Then Figure-of-eight Active Coil; Then Round Active
Arm/Group Description rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. 12 week follow-up period
Measure Participants 4 4 3
excluded by investigator from concluding study
0
0%
1
NaN
0
NaN
stopped due to intolerance/ inefficiency
0
0%
1
NaN
0
NaN
stopped due to seizure worsening
1
9.1%
0
NaN
0
NaN
7. Other Pre-specified Outcome
Title Adverse Event Rate
Description
Time Frame during the 9 months of the study

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Figure-of-eight Active rTMS Coil Round Active rTMS Coil Sham rTMS Coil (Figure-of-eight)
Arm/Group Description rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered. rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered. rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks. All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered.
Measure Participants 9 10 8
worsening seizures
2
18.2%
1
NaN
0
NaN
hearing problems
1
9.1%
1
NaN
0
NaN
fatigue
2
18.2%
2
NaN
2
NaN
concentration difficulties
1
9.1%
1
NaN
1
NaN

Adverse Events

Time Frame 9-month study duration
Adverse Event Reporting Description
Arm/Group Title Figure-of-eight Active rTMS Coil Round Active rTMS Coil Sham rTMS Coil (Figure-of-eight)
Arm/Group Description rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. figure-of-eight active rTMS coil: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. round active rTMS coil: navigated rTMS over epileptogenic focus using round active rTMS coil rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks. sham rTMS coil (figure-of-eight): placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue
All Cause Mortality
Figure-of-eight Active rTMS Coil Round Active rTMS Coil Sham rTMS Coil (Figure-of-eight)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Figure-of-eight Active rTMS Coil Round Active rTMS Coil Sham rTMS Coil (Figure-of-eight)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/9 (22.2%) 1/10 (10%) 0/9 (0%)
Nervous system disorders
seizure excacerbation 2/9 (22.2%) 1/10 (10%) 0/9 (0%)
Other (Not Including Serious) Adverse Events
Figure-of-eight Active rTMS Coil Round Active rTMS Coil Sham rTMS Coil (Figure-of-eight)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/9 (33.3%) 3/10 (30%) 3/9 (33.3%)
Nervous system disorders
fatigue, concentration difficulties 3/9 (33.3%) 3/10 (30%) 3/9 (33.3%)

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 Prof W Van Paesschen & Dr L Seynaeve
Organization UZ Leuven
Phone +3216349062
Email laura.seynaeve@uzleuven.be
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01745952
Other Study ID Numbers:
  • s52486
First Posted:
Dec 10, 2012
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020