Clinical trial NCT02057276: Repetitive TMS and Occupational Therapy in Children and Young Adults With Chronic Hemiparesis
Official title: Motor Control Enhancement Through Repetitive Transcranial Magnetic Stimulation Plus Rehabilitation in Hemiparetic Cerebral Palsy and Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pediatric Stroke
Cerebral Palsy
Chronic Hemiparesis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 2
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
measure: Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
timeFrame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 7 days after rTMS/OT
measure: Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
timeFrame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 12 weeks after rTMS/OT
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Steve W Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: