NCT02057276

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

August 3, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

June 5, 2013

Results QC Date

July 30, 2015

Last Update Submit

February 2, 2017

Conditions

Pediatric StrokeCerebral PalsyChronic Hemiparesis

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (2)

  • 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

  • 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

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

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

Device: Repetitive Transcranial Magnetic StimulationOther: Occupational Therapy

Sham rTMS

SHAM COMPARATOR

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

Device: Sham Repetitive Transcranial Magnetic StimulationOther: Occupational Therapy

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

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

Active rTMS
Sham Repetitive Transcranial Magnetic StimulationDEVICE
Sham rTMS
Occupational TherapyOTHER
Active rTMSSham rTMS

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Magnetic StimulationOccupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient Care

Results Point of Contact

Title
Steve Wu, MD
Organization
Cincinnati Children's Hospital Medical Center
steve.wu@cchmc.org
513-636-4222

Study Officials

  • Steve W Wu, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2013

First Posted

February 7, 2014

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

March 14, 2017

Results First Posted

August 3, 2015

Record last verified: 2017-02

Locations

US(1)