Repetitive TMS and Occupational Therapy in Children and Young Adults With Chronic Hemiparesis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Repetitive Transcranial Magnetic Stimulation (rTMS) can augment occupational therapy in improving motor function in children (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis from either stroke or cerebral palsy.

Detailed Description
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RTMS is a noninvasive technology that can induce changes in brain function that may lead to functional improvement in people with hemiparesis. This is a randomized, double-blinded, sham-controlled rTMS study in conjunction with intensive daily occupational therapy (OT) for 2 weeks to improve motor function in hemiparetic patients. Participants will be followed for at least 12 weeks after rTMS to detect any clinical change. The sham group participants will be offered an open-label active rTMS treatment plus OT after the 12 week assessment.

Official Title
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Motor Control Enhancement Through Repetitive Transcranial Magnetic Stimulation Plus Rehabilitation in Hemiparetic Cerebral Palsy and Stroke

Conditions
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Pediatric Stroke, Cerebral Palsy, Chronic Hemiparesis

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation
* Device: Sham Repetitive Transcranial Magnetic Stimulation
* Other: Occupational Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 10 years; < 21 years Hemiparesis Manual Ability Classification System (MACS) level I through IV Provision of written informed consent by the patient and/or guardian, including understanding that insurance may be billed for the occupational therapy Written assent form signed by participants younger than 18 years of age Exclusion Criteria: Underlying degenerative or metabolic disorder or supervening medical illness Severe depression or other psychiatric disorder Any participant who is pregnant Any contraindication to TMS (i.e., intracranial metal implants, shunts, ports, pacemaker, baclofen pumps) Any changes or addition of neuropsychiatric medications within 1 month of starting the study or during course of the study (if applicable) Any botulinum toxin (Botox, Myobloc) or phenol injection within the last 3 months prior to the study or during the course of the study (if applicable) Any upper extremity surgery within the last 6 months prior to the study or scheduled during the course of the study (if applicable)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active rTMS<br>Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. | Device: Repetitive Transcranial Magnetic Stimulation<br>* We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.<br>Other: Occupational Therapy<br> <br> |
| Sham Comparator: Sham rTMS<br>Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. | Device: Sham Repetitive Transcranial Magnetic Stimulation<br> <br> Other: Occupational Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Melbourne Assessment of Unilateral Upper Limb Function |  | Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 3 days after rTMS/OT |