Pediatric Hemiplegia: Synergistic Treatment Using rTMS and CIT
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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 |
- 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
- 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.
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated 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 |
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| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | James R Carey, PhD, PT | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
No publications provided
| 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: | July 12, 2012 |
| 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 Stroke Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013