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

NCT ID: NCT02057276

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-06-30

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.

Conditions

Pediatric Stroke; Cerebral Palsy; Chronic Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active rTMS

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

Group Type: ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.

Occupational Therapy

Intervention Type: OTHER

Sham rTMS

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

Group Type: SHAM_COMPARATOR

Sham Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Occupational Therapy

Intervention Type: OTHER

Interventions

Repetitive Transcranial Magnetic Stimulation

We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.

Intervention Type: DEVICE

Sham Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Occupational Therapy

Intervention Type: OTHER

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve W Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2012-1533

Identifier Type: OTHER

Identifier Source: secondary_id

CIN001 - rTMS/hemiparesis

Identifier Type: -

Identifier Source: org_study_id