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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057276
Recruitment Status : Terminated (Study was terminated due to low recruitment.)
First Posted : February 7, 2014
Results First Posted : August 3, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric Stroke Cerebral Palsy Chronic Hemiparesis Device: Repetitive Transcranial Magnetic Stimulation Device: Sham Repetitive Transcranial Magnetic Stimulation Other: Occupational Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motor Control Enhancement Through Repetitive Transcranial Magnetic Stimulation Plus Rehabilitation in Hemiparetic Cerebral Palsy and Stroke
Study Start Date : September 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2016

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Arms and Interventions
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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.
 Device: Sham Repetitive Transcranial Magnetic Stimulation
Other: Occupational Therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures:
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057276


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Steve W Wu, MD Children's Hospital Medical Center, Cincinnati
More Information
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02057276    
Other Study ID Numbers: CIN001 - rTMS/hemiparesis
2012-1533 ( Other Identifier: Cincinnati Children's Hospital Medical Center )
First Posted: February 7, 2014    Key Record Dates
Results First Posted: August 3, 2015
Last Update Posted: March 14, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Cerebral Palsy
Paresis
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Brain Damage, Chronic
Neurologic Manifestations
Signs and Symptoms