NICHE: Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial

• Sponsor: Nexstim Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02089464
• Collaborator: (none)
• Enrollment: 199
• Locations: 12
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 16.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: NBS-guided rTMS; Device: Sham rTMS; Procedure: Task oriented rehabilitation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 199 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pivotal Phase III, Prospective, Multicenter, Double Blinded, Randomized, Sham Controlled Trial to Determine the Therapeutic Effects of Navigation Guided 1 Hz rTMS Administered to the Contralesional Hemisphere as Adjuvant to Task Oriented Rehabilitation in Patients With Ischemic or Hemorrhagic Stroke
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NBS-rTMS + task-oriented rehabilitation NBS-guided rTMS + task-oriented rehabilitation	Device: NBS-guided rTMS; Other Names: Nexstim ; Procedure: Task oriented rehabilitation
Sham Comparator: Sham rTMS + task-oriented rehabilitation Sham rTMS + task-oriented rehabilitation	Device: Sham rTMS; Procedure: Task oriented rehabilitation

Outcome Measures

Primary Outcome Measures

1. Upper Extremity Fugl-Meyer Score [Baseline - 6 months post-treatment]

   Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).

Secondary Outcome Measures

1. Arm-Research Action Test (ARAT) [Baseline - 6 months post-treatment]

   Scale minimum 0, maximum 57. Greater values indicate better motor function.

2. Wolf Motor Function Test [Baseline - 6 months post-treatment]

   Time in seconds to perform test tasks. Shorter time indicates better motor function.

3. NIH Stroke Scale (NIHSS) [Baseline - 6 months post-treatment]

   Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42)

4. Chedoke-McMaster Stroke Assessment (CMSA) [Baseline - 6 months post-treatment]

   Scale minimum 1, maximum 7. Higher values indicate better motor function of hand.

5. Stroke Impact Scale (SIS) [Baseline - 6 months post-treatment]

   Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function

6. Patient Health Questionnaire (PHQ9) [Baseline - 6 months post-treatment]

   The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood

7. Quality of Life Assessment: EuroQol EQ-5D Scale [Baseline - 6 months post-treatment]

   The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life.

Other Outcome Measures

1. To Assess Safety of Study Device Use, All Serious Adverse Events Will be Recorded and Compared Between Groups [Baseline - 6 months post-treatment]

   Serious Adverse Events were recorded and their occurrence was compared between treatment arms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria :

• ≥ 18 years of age

• An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study;

• no other known brain abnormalities by history;

• A one-sided stroke resulting in upper extremity paresis

• A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb

Exclusion Criteria

• Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;

• Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.

• Active alcohol abuse, illicit drug use or drug abuse or significant mental illness

• Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial.

• History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months.

• Any condition that would prevent the subject from giving voluntary informed consent;

• An implanted brain stimulator;

• Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body;

• Enrolled or plans to enroll in an interventional trial during this study;

• Scalp wounds or infections;

• Claustrophobia precluding MRI;

• A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;

• Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i

• previous stroke with residual deficits (TIAs not a reason for exclusion);

• premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;

• a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition,

• confirmed or suspected lower-limb fracture preventing mobilization,

• patients requiring palliative care

• patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study

• A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up.

• A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up.

• Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.

• Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.

• Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.

• Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.

• Patients unable to comprehend or follow verbal commands

• Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition

• A Mini mental status exam (MMSE) <25.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Phoenix	Arizona	United States	85054
2	Rancho Los Amigos National Rehabilitation Center	Downey	California	United States	90242
3	Shepherd Rehabilitation Center	Atlanta	Georgia	United States	30309
4	Rehabilitation Institute of Chicago	Chicago	Illinois	United States	60611
5	Indiana University Indianapolis	Indianapolis	Indiana	United States	46202
6	Spaulding Rehabilitation Hospital	Boston	Massachusetts	United States	02129
7	Columbia Cornell New York Presbyterian Hospital	New York	New York	United States	10032
8	Burke Medical Research Institute, Weill Cornell Neurology	White Plains	New York	United States	10605
9	Duke University Medical Center	Durham	North Carolina	United States	27705
10	University of Cincinnati	Cincinnati	Ohio	United States	45267
11	Ohio State University	Columbus	Ohio	United States	43210
12	TIRR Memorial Hermann Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Nexstim Ltd

Investigators

• Principal Investigator: Richard L Harvey, MD, Shirley Ryan AbilityLab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nexstim Ltd
• ClinicalTrials.gov Identifier: NCT02089464
• Other Study ID Numbers: NX92325
• First Posted: Mar 17, 2014
• Last Update Posted: Sep 1, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Period Title: Overall Study
STARTED	132	67
COMPLETED	104	51
NOT COMPLETED	28	16

Baseline Characteristics

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation	Total
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation	Total of all reporting groups
Overall Participants	132	67	199
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.2 (13.3)	57.6 (12.7)	58.7 (13.1)
Sex: Female, Male (Count of Participants)
Female	44 33.3%	25 37.3%	69 34.7%
Male	88 66.7%	42 62.7%	130 65.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 20.5%	18 26.9%	45 22.6%
Not Hispanic or Latino	105 79.5%	49 73.1%	154 77.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	7 5.3%	5 7.5%	12 6%
Native Hawaiian or Other Pacific Islander	2 1.5%	0 0%	2 1%
Black or African American	35 26.5%	12 17.9%	47 23.6%
White	83 62.9%	47 70.1%	130 65.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	5 3.8%	3 4.5%	8 4%
Region of Enrollment (participants) [Number]
United States	132 100%	67 100%	199 100%
Upper Extremity Fugl-Meyer (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	34.0 (12.2)	35.0 (12.5)	34.3 (12.3)
Arm Research Action Test (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	27.3 (16.3)	30.0 (15.8)	28.2 (16.1)
Wolf Motor Function Test (seconds of time) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds of time]	32.1 (48.4)	29.4 (46.8)	31.2 (48.1)
Chedoke-McMaster Stroke Assessment Hand (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.0 (0.9)	4.1 (1.0)	4.0 (0.9)
Chedoke-McMaster Stroke Assessment Arn (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (0.8)	3.6 (0.9)	3.5 (0.9)
NIH Stroke Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.7 (1.6)	2.3 (1.9)	2.6 (1.8)
Stroke Impact Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	63.3 (16.9)	65.3 (16.0)	64.7 (16.8)
Patient Health Questionnaire - 9 (PHQ9) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (2.9)	3.7 (3.2)	3.6 (3.0)
EuroQol ED-5Q scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	68.2 (18.4)	70.4 (17.9)	68.8 (18.3)

Outcome Measures

1. Primary Outcome

Title	Upper Extremity Fugl-Meyer Score
Description	Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Count of Participants [Participants]	88 66.7%	43 64.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NBS-rTMS + Task-oriented Rehabilitation, Sham rTMS + Task-oriented Rehabilitation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.76
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Arm-Research Action Test (ARAT)
Description	Scale minimum 0, maximum 57. Greater values indicate better motor function.
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Mean (Standard Deviation) [units on a scale]	5.0 (7.7)	5.0 (10.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NBS-rTMS + Task-oriented Rehabilitation, Sham rTMS + Task-oriented Rehabilitation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Wolf Motor Function Test
Description	Time in seconds to perform test tasks. Shorter time indicates better motor function.
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Mean (Standard Deviation) [seconds of time]	-9.0 (29.5)	-10.6 (36.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NBS-rTMS + Task-oriented Rehabilitation, Sham rTMS + Task-oriented Rehabilitation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	NIH Stroke Scale (NIHSS)
Description	Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42)
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Mean (Standard Deviation) [units on a scale]	-0.4 (1.3)	-0.7 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NBS-rTMS + Task-oriented Rehabilitation, Sham rTMS + Task-oriented Rehabilitation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Chedoke-McMaster Stroke Assessment (CMSA)
Description	Scale minimum 1, maximum 7. Higher values indicate better motor function of hand.
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Mean (Standard Deviation) [units on a scale]	0.5 (1.0)	0.5 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NBS-rTMS + Task-oriented Rehabilitation, Sham rTMS + Task-oriented Rehabilitation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Stroke Impact Scale (SIS)
Description	Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Mean (Standard Deviation) [units on a scale]	6.7 (11.6)	8.7 (14.5)

7. Secondary Outcome

Title	Patient Health Questionnaire (PHQ9)
Description	The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Mean (Standard Deviation) [units on a scale]	-0.2 (3.3)	0.0 (4.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NBS-rTMS + Task-oriented Rehabilitation, Sham rTMS + Task-oriented Rehabilitation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.95
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Quality of Life Assessment: EuroQol EQ-5D Scale
Description	The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life.
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Mean (Standard Deviation) [units on a scale]	7.7 (15.7)	6.9 (14.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NBS-rTMS + Task-oriented Rehabilitation, Sham rTMS + Task-oriented Rehabilitation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	Method	t-test, 2 sided
	Comments

9. Other Pre-specified Outcome

Title	To Assess Safety of Study Device Use, All Serious Adverse Events Will be Recorded and Compared Between Groups
Description	Serious Adverse Events were recorded and their occurrence was compared between treatment arms
Time Frame	Baseline - 6 months post-treatment

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation	Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
Measure Participants	132	67
Number [number of events]	16	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NBS-rTMS + Task-oriented Rehabilitation, Sham rTMS + Task-oriented Rehabilitation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	NBS-rTMS + Task-oriented Rehabilitation		Sham rTMS + Task-oriented Rehabilitation
Arm/Group Description	NBS-guided rTMS + task-oriented rehabilitation NBS-guided rTMS Task oriented rehabilitation		Sham rTMS + task-oriented rehabilitation Sham rTMS Task oriented rehabilitation
All Cause Mortality
	NBS-rTMS + Task-oriented Rehabilitation		Sham rTMS + Task-oriented Rehabilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/132 (0.8%)		0/67 (0%)
Serious Adverse Events
	NBS-rTMS + Task-oriented Rehabilitation		Sham rTMS + Task-oriented Rehabilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/132 (8.3%)		7/67 (10.4%)
Blood and lymphatic system disorders
Haemorrhagic anaemia	1/132 (0.8%)	1	0/67 (0%)	0
Cardiac disorders
cardiac failure congestive	1/132 (0.8%)	1	1/67 (1.5%)	1
General disorders
Thrombosis in device	1/132 (0.8%)	1	0/67 (0%)	0
Infections and infestations
Pneumonia	2/132 (1.5%)	2	0/67 (0%)	0
Device related infection	1/132 (0.8%)	1	0/67 (0%)	0
Metabolism and nutrition disorders
Hyperglycemia	1/132 (0.8%)	1	0/67 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	0/132 (0%)	0	1/67 (1.5%)	1
Nervous system disorders
Cerebrovascular accident	0/132 (0%)	0	2/67 (3%)	2
Carotid artery disease	1/132 (0.8%)	1	0/67 (0%)	0
Convulsion	0/132 (0%)	0	1/67 (1.5%)	1
Hemiparesis	1/132 (0.8%)	1	0/67 (0%)	0
VIIth nerve paralysis	1/132 (0.8%)	1	0/67 (0%)	0
Psychiatric disorders
Depression	0/132 (0%)	0	1/67 (1.5%)	1
Suicidal ideation	1/132 (0.8%)	1	0/67 (0%)	0
Renal and urinary disorders
Hydronephrosis	1/132 (0.8%)	1	0/67 (0%)	0
Nephrolithiasis	1/132 (0.8%)	1	0/67 (0%)	0
Renal failure acute	0/132 (0%)	0	1/67 (1.5%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/132 (0.8%)	1	0/67 (0%)	0
Surgical and medical procedures
Coronary artery bypass	0/132 (0%)	0	1/67 (1.5%)	1
Hip surgery	1/132 (0.8%)	1	0/67 (0%)	0
Vascular disorders
Hypertensive crisis	1/132 (0.8%)	1	1/67 (1.5%)	1
Deep vein thrombosis	0/132 (0%)	0	1/67 (1.5%)	1
Other (Not Including Serious) Adverse Events
	NBS-rTMS + Task-oriented Rehabilitation		Sham rTMS + Task-oriented Rehabilitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/132 (22.7%)		15/67 (22.4%)
Eye disorders
Increased lacrimation	0/132 (0%)	0	1/67 (1.5%)	1
Blepharospasm	1/132 (0.8%)	1	0/67 (0%)	0
General disorders
Fatigue	4/132 (3%)	5	2/67 (3%)	3
Injury, poisoning and procedural complications
Fall	2/132 (1.5%)	2	1/67 (1.5%)	1
Musculoskeletal and connective tissue disorders
Spasms in hand	1/132 (0.8%)	1	0/67 (0%)	0
Musculoskeletal pain	4/132 (3%)	4	2/67 (3%)	2
Myalgia	1/132 (0.8%)	1	0/67 (0%)	0
Nervous system disorders
Headache	5/132 (3.8%)	7	2/67 (3%)	3
Paresthesia	3/132 (2.3%)	4	1/67 (1.5%)	2
Muscle spasticity	1/132 (0.8%)	1	1/67 (1.5%)	1
Dizziness	2/132 (1.5%)	2	2/67 (3%)	2
Tremor	2/132 (1.5%)	2	0/67 (0%)	0
Psychiatric disorders
Depression	1/132 (0.8%)	1	1/67 (1.5%)	1
Panic attack	1/132 (0.8%)	1	0/67 (0%)	0
Hallucination olfactory	0/132 (0%)	0	1/67 (1.5%)	1
Hallucination auditory	0/132 (0%)	0	1/67 (1.5%)	1
Skin and subcutaneous tissue disorders
Rash	1/132 (0.8%)	1	0/67 (0%)	0
Photosensitivity reaction	1/132 (0.8%)	1	0/67 (0%)	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.