Pediatric Hemiplegia: Synergistic Treatment Using rTMS and CIT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01104064
First received: April 13, 2010
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

The strategy in rehabilitating pediatric hemiplegia is to overcome "developmental disuse". Disruption of the excitability in the non-stroke hemisphere, with resultant increased excitability (disinhibition) in the stroke hemisphere, can be achieved with low-frequency repetitive transcranial magnetic stimulation (rTMS), a noninvasive method of stimulating targeted areas of the brain. Furthermore, the disruptive effects of low-frequency rTMS can be increased and prolonged by preceding it with 6-Hz priming stimulation. We have recently demonstrated the safety of this priming/low-frequency rTMS in adults with stroke and we are currently engaged in an NIH-funded study exploring the effectiveness, mechanism and safety of serial treatments of rTMS combined with motor learning training. Very little research, however, has been attempted on interventions to promote brain reorganization and recovery in hemiplegia in children. Thus, this study will determine the effectiveness, mechanism, and safety of 5 treatments of 6-Hz primed low-frequency rTMS applied to the non-stroke hemisphere and combined with constraint induced therapy (CIT) to promote recovery of the paretic hand. Fifteen children with pediatric hemiplegia, age 8 -16 years, at each of two pediatric medical facilities (total N = 30), will be randomly assigned to one of two treatment groups that will receive treatment for 2 weeks. The rTMSreal/CIT group will receive alternating days of the real rTMS and CIT for 5 treatments of each. The rTMSsham/CIT group will receive alternating days of sham rTMS with real CIT for 5 treatments of each. Subjects will be tested at pretest and posttest. The hypotheses are: 1) the rTMS treatment will show no serious side effects, 2) both groups will show improvement in hand function but the rTMSsham/CIT group will show significantly greater improvement, 3) the rTMSreal/CIT group will also show significantly greater improvements in brain reorganization measured by paired-pulse TMS testing, cortical silent period testing, and fMRI. The proposed research is important because very little research on rehabilitation-induced brain reorganization has been done in pediatric hemiplegia. It is innovative because it applies a technique never used before, i.e. 6-Hz primed low-frequency rTMS combined with CIT. The potential impact of this research is a radical change to pediatric rehabilitation that accomplishes a higher functional recovery.


Condition Intervention Phase
Stroke
Device: real rTMS combined with constraint induced therapy
Device: sham rTMS combined with constraint induced therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pediatric Hemiplegia: Synergistic Treatment Using rTMS and CIT

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Hand function assessment [ Time Frame: Pretest, posttest ] [ Designated as safety issue: Yes ]
    Hand function will be assessed at pretest and posttest by a tester rating the child's performance on designated motor tasks


Secondary Outcome Measures:
  • cortical excitability [ Time Frame: pretest and posttest ] [ Designated as safety issue: No ]
    Cortical excitability of the primary motor cortex of the stroke hemisphere will be assessed using paired-pulse transcranial magnetic stimulation.


Enrollment: 19
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Real rTMS combined with CIT Device: real rTMS combined with constraint induced therapy
10 minutes of priming followed by 10 minutes of low-frequency is followed on the next day with constraint induced therapy. A total of 5 treatment days for each therapy is given.
Sham Comparator: Sham rTMS combined with CIT Device: sham rTMS combined with constraint induced therapy
10 minutes of sham priming followed by 10 minutes of sham low-frequency is followed on the next day with constraint induced therapy. A total of 5 treatment days for each therapy is given.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 10 degrees of active finger (metacarpophalangeal joint) and wrist flexion/extension motion,
  • ability to see whether a computer screen cursor is slightly above/below a target line,
  • ability to understand finger tracking test evidenced by a score above 0,
  • evidence of an MEP in paretic hand muscle with TMS testing of ipsilesional M1, age-equivalent receptive language function.

Exclusion Criteria:

  • metabolic disorders,
  • neoplasm,
  • seizures,
  • disorders of cellular migration and proliferation,
  • lack of age appropriate receptive language function,
  • expressive aphasia,
  • pregnancy,
  • claustrophobia,
  • indwelling metal or MRI incompatible medical devices,
  • gross visual field cuts.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01104064

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: James R Carey, PhD, PT University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01104064     History of Changes
Other Study ID Numbers: Pediatric Hemiplegia and rTMS
Study First Received: April 13, 2010
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Stroke

Additional relevant MeSH terms:
Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014