Pediatric Hemiplegia: Synergistic Treatment Using rTMS and CIT

NCT01104064 | Completed Phase 1

• 1 other identifier: Pediatric Hemiplegia and rTMS
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

• Hand function assessment

  Hand function will be assessed at pretest and posttest by a tester rating the child's performance on designated motor tasks

  Pretest, posttest

Secondary Outcomes (1)

• cortical excitability

  pretest and posttest

Study Arms (2)

Real rTMS combined with CIT

EXPERIMENTAL

Device: real rTMS combined with constraint induced therapy

Sham rTMS combined with CIT

SHAM COMPARATOR

Device: sham rTMS combined with constraint induced therapy

Interventions

real rTMS combined with constraint induced therapy DEVICE

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.

Real rTMS combined with CIT

sham rTMS combined with constraint induced therapy DEVICE

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.

Sham rTMS combined with CIT

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• Gillick BT, Krach LE, Feyma T, Rich TL, Moberg K, Menk J, Cassidy J, Kimberley T, Carey JR. Safety of primed repetitive transcranial magnetic stimulation and modified constraint-induced movement therapy in a randomized controlled trial in pediatric hemiparesis. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S104-13. doi: 10.1016/j.apmr.2014.09.012. Epub 2014 Oct 2.

  PMID: 25283350 DERIVED

• Gillick BT, Krach LE, Feyma T, Rich TL, Moberg K, Thomas W, Cassidy JM, Menk J, Carey JR. Primed low-frequency repetitive transcranial magnetic stimulation and constraint-induced movement therapy in pediatric hemiparesis: a randomized controlled trial. Dev Med Child Neurol. 2014 Jan;56(1):44-52. doi: 10.1111/dmcn.12243. Epub 2013 Aug 21.

  PMID: 23962321 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James R Carey, PhD, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

US (1)