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

Cerebral Palsy Clinical Trial

Official title:

Motor Control Enhancement Through Repetitive Transcranial Magnetic Stimulation Plus Rehabilitation in Hemiparetic Cerebral Palsy and Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02057276
• Other study ID #: CIN001 - rTMS/hemiparesis
• Secondary ID: 2012-1533
• Status: Terminated
• Phase: Phase 2
• First received: June 5, 2013
• Last updated: July 30, 2015
• Start date: September 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 20 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Chronic Hemiparesis
• Pediatric Stroke

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
• Sham Repetitive Transcranial Magnetic Stimulation

Other:
• Occupational Therapy

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the "Melbourne Assessment of Unilateral Upper Limb Function"		Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 7 days after rTMS/OT	No
Other	Change in the "Melbourne Assessment of Unilateral Upper Limb Function"		Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 12 weeks after rTMS/OT	No
Primary	Change in the "Melbourne Assessment of Unilateral Upper Limb Function"		Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT	No