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



Status:Terminated
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:10 - 20
Updated:4/21/2016
Start Date:September 2012
End Date:June 2016

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

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.

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.

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)
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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from
Cincinnati, OH
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