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

Primary Purpose

Pediatric Stroke, Cerebral Palsy, Chronic Hemiparesis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic Stimulation
Occupational Therapy
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Stroke

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active rTMS

Sham rTMS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in the "Melbourne Assessment of Unilateral Upper Limb Function"

Secondary Outcome Measures

Full Information

First Posted
June 5, 2013
Last Updated
February 2, 2017
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02057276
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to low recruitment.
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Stroke, Cerebral Palsy, Chronic Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS
Arm Type
Active Comparator
Arm Description
Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Intervention Type
Device
Intervention Name(s)
Sham Repetitive Transcranial Magnetic Stimulation
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Primary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve W Wu, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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