Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.

Detailed Description
-----------------
This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved. This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.

Official Title
-----------------
An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: repetitive Transcranial Magnetic Stimulation -On
* Device: repetitive Transcranial Magnetic Stimulation -Off


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-80 years; Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; -- Exclusion Criteria: History of seizure; Epileptogenic activity (indicative of increased risk of seizures) on EEG; Any active unstable medical condition; Pregnancy; Schizophrenia, bipolar disorder, alcoholism, or substance abuse; Medications which in the investigator's clinical judgment significantly lower the seizure threshold; Presence of metal or electronic implants in the head (or any in the body that preclude MRI) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.; Any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study. Botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study Changes in NIHSS and motor assessment scores between Visit 1 and Visit 2 indicating that the patient's impairment is not stable. The following cutoffs, based on research establishing Clinically Important Differences, will be used for this determination: National Institutes of Health Stroke Scale: A change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction. Fugl-Meyer Assessment of Sensorimotor Impairment: A change of more than 5 points in either direction on the upper-extremity motor score for the affected arm. Action Research Arm Test: A change of more than 5 points in either direction on the ARAT score for the affected arm. Any condition that precludes a high quality brain MRI scan.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: repetitive Transcranial Magnetic Stimulation -On<br>Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain. | Device: repetitive Transcranial Magnetic Stimulation -On<br>* Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain<br>* Other names: repetitive Transcranial Magnetic Stimulation (rTMS);|
| Sham Comparator: repetitive Transcranial Magnetic Stimulation -Off<br>Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain. | Device: repetitive Transcranial Magnetic Stimulation -Off<br>* Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.<br>* Other names: Control Group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Brain Activation | Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI | One business day before treatment begins, one business day after treatment ends, up to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Motor Arm Score | Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome | One business day before treatment begins, one business day after treatment ends up to 5 weeks | 
| ARAT (Action Research Arm Test) | Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome | One business day before treatment begins, one business day after treatment ends up to 5 weeks | 
| Hand Dynamometer | Change in grip strength The higher the number represents better outcome | One business day before treatment begins, one business day after treatment ends up to 5 weeks | 
| Pinch Dynamometer Score | Change in pinch strength. The higher the number, the better the outcome. | One business day before treatment begins, one business day after treatment ends up to 5 weeks | 
| TUG (Timed Up and Go Test) | Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome. | One business day before treatment begins, one business day after treatment ends up to 5 weeks | 
| National Institutes of Health Stroke Scale (NIHSS) | Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome | One business day before treatment begins, one business day after treatment ends up to 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, chronic ischemic stroke, cerebrovascular accident (CVA), ischaemic stroke