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

Not Applicable

Terminated

Interventions: Device: Repetitive Transcranial Magnetic Stimulation
Device: Sham Repetitive Transcranial Magnetic Stimulation
Other: Occupational Therapy

Brief Summary: 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: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Active rTMS	Repetitive Transcranial Magnetic Stimulation	Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Active rTMS	Occupational Therapy	Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Sham rTMS	Sham Repetitive Transcranial Magnetic Stimulation	Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Sham rTMS	Occupational Therapy	Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures