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

February 2, 2017 updated by: Children's Hospital Medical Center, Cincinnati

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active rTMS
Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Device: Repetitive Transcranial Magnetic Stimulation
We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Other: Occupational Therapy
SHAM_COMPARATOR: Sham rTMS
Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Other: Occupational Therapy
Device: Sham Repetitive Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
Time Frame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT
Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT

Other Outcome Measures

Outcome Measure
Time Frame
Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
Time Frame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 7 days after rTMS/OT
Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 7 days after rTMS/OT
Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
Time Frame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 12 weeks after rTMS/OT
Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 12 weeks after rTMS/OT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Steve W Wu, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

February 5, 2014

First Posted (ESTIMATE)

February 7, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN001 - rTMS/hemiparesis
  • 2012-1533 (OTHER: Cincinnati Children's Hospital Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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