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

Cincinnati Children's Hospital Medical Center

Status: Terminated

Conditions: Cerebral Palsy; Chronic Hemiparesis; Pediatric Stroke

Treatments: Device: Repetitive Transcranial Magnetic Stimulation; Other: Occupational Therapy; Device: Sham Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02057276

CIN001 - rTMS/hemiparesis

2012-1533 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 10 to 20 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups

Active rTMS

Active Comparator group

Description:

Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.

Treatment:

Other: Occupational Therapy

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

Sham Comparator group

Description:

Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.

Treatment:

Device: Sham Repetitive Transcranial Magnetic Stimulation

Other: Occupational Therapy