Repetitive TMS and Occupational Therapy in Children and Young Adults With Chronic Hemiparesis (NCT02057276) | Clinical Trial Compass
TerminatedNot Applicable
Repetitive TMS and Occupational Therapy in Children and Young Adults With Chronic Hemiparesis
Stopped: Study was terminated due to low recruitment.
United States2 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range
10 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
Timeframe: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT
Trial details
NCT IDNCT02057276
SponsorChildren's Hospital Medical Center, Cincinnati