Clinical trial NCT02250092: Brain Stimulation and Hand Training in Children With Hemiparesis
Official title: Synergistic Effect of Combined Transcranial Direct Current Stimulation/Constraint Induced Movement Therapy in Children With Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Hemiparesis
Keywords: Cerebral Palsy
Hemiparesis
Stroke
Non-Invasive Brain Stimulation
Transcranial Direct Current Stimulation
Constraint-Induced Movement Therapy
Diffusion Tensor Imaging
Congenital Hemiparesis
Bimanual Therapy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Cerebral Palsy International Research Foundation
name: Foundation for Physical Therapy, Inc.
name: National Institutes of Health (NIH)
First posted: 2014-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemiparetic cerebral palsy influences motor function in children during development and throughout their lifetime. The deficits one sees are the result both of the congenitally induced brain lesion and the subsequent plasticity that can impair function of the surviving neurons in the damaged brain.

Many current treatments have limited influence on children's neurorecovery. Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to encourage use of the affected limb has shown promise, yet with new technology revealing the potential to directly influence the brain, there is an urgent need to study the synergy of combined techniques.

Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the potential to act synergistically with CIMT to influence neurorecovery.

Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the influence of this intervention on improved motor outcomes in children with cerebral palsy. The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS wherein those children who receive the combined intervention will reveal no major adverse events, yet improved hand function and cortical excitability.

To Note: In addition to the combination of NIBS with CIMT, we also investigated the combination of NIBS with another form of motor intervention, bimanual, or two-handed, training. During bimanual training, children engage both hands in movements. The goal of bimanual training is to teach children how to most effectively use their hands cooperatively. During bimanual training, children play with games and toys that require the use of both hands. Children also practice activities of daily living that require the use of both hands, such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot study and no randomization. (Burke Medical Research Institute partnered with Columbia University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)

Detailed description: We use single-pulse transcranial magnetic stimulation (TMS) to measure the location and strength of brain connections that control hand movements.

Eligibility criteria: Inclusion Criteria:

1. Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT radiologic report with resultant congenital hemiparesis
2. ≥ 10 degrees of active motion at the metacarpophalangeal joint
3. Receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
4. No evidence of seizure activity within the last 2 years
5. Presence of a motor evoked potential from at least the contralesional hemisphere if not both hemispheres
6. Ages 8-21 years
7. Able to give informed assent along with the informed consent of the legal guardian
8. Children who have had surgeries, which may influence motor function eg- tendon transfer, will be included, yet surgical history will be documented and included in any publication within a participant characteristics table.

Exclusion Criteria:

1. Metabolic Disorders
2. Neoplasm
3. Epilepsy
4. Disorders of Cellular Migration and Proliferation
5. Acquired Traumatic Brain Injury
6. Pregnancy
7. Indwelling metal or incompatible medical devices
8. Evidence of skin disease or skin abnormalities
9. Botulinum toxin or Phenol block within \[six-months\] preceding the study

Primary outcomes:
measure: Change in Assisting Hand Assessment (AHA)
timeFrame: 2 weeks, 6 months
Secondary outcomes:
measure: Change in Canadian Occupational Performance Measurement (COPM)
timeFrame: 2 weeks, 6 months
Other outcomes:
measure: Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months
timeFrame: 2 weeks, 6 months
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Bernadette T Gillick, PhD, MSPT, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillick B, Menk J, Mueller B, Meekins G, Krach LE, Feyma T, Rudser K. Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol. BMC Pediatr. 2015 Nov 12;15:178. doi: 10.1186/s12887-015-0498-1.
citation: Lixandrao MC, Stinear JW, Rich T, Chen CY, Feyma T, Meekins GD, Gillick BT. EMG breakthrough during cortical silent period in congenital hemiparesis: a descriptive case series. Braz J Phys Ther. 2020 Jan-Feb;24(1):20-29. doi: 10.1016/j.bjpt.2018.11.002. Epub 2018 Nov 22.