Brain Stimulation and Hand Training in Children With Hemiparesis

NCT02250092 | Completed Results FDA Device

• 1 other identifier: 1408M53169
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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)

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

Outcome Measures

Primary Outcomes (1)

• Change in Assisting Hand Assessment (AHA)

  Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.

  2 weeks, 6 months

Secondary Outcomes (1)

• Change in Canadian Occupational Performance Measurement (COPM)

  2 weeks, 6 months

Other Outcomes (1)

• Change in Subject Symptom Assessment (SSA) From 2 Weeks to 6 Months

  2 weeks, 6 months

Study Arms (2)

tDCS/CIMT

ACTIVE COMPARATOR

Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.

Device: Transcranial Direct Current Stimulation (tDCS)

tDCS sham/CIMT

PLACEBO COMPARATOR

Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.

Device: Placebo Comparator

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

10 tDCS/CIMT Sessions

Also known as: tDCS, Brain Stimulation

tDCS/CIMT

Placebo Comparator DEVICE

tDCS sham/CIMT

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT radiologic report with resultant congenital hemiparesis
• ≥ 10 degrees of active motion at the metacarpophalangeal joint
• Receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
• No evidence of seizure activity within the last 2 years
• Presence of a motor evoked potential from at least the contralesional hemisphere if not both hemispheres
• Ages 8-21 years
• Able to give informed assent along with the informed consent of the legal guardian
• 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.

You may not qualify if:

• Metabolic Disorders
• Neoplasm
• Epilepsy
• Disorders of Cellular Migration and Proliferation
• Acquired Traumatic Brain Injury
• Pregnancy
• Indwelling metal or incompatible medical devices
• Evidence of skin disease or skin abnormalities
• Botulinum toxin or Phenol block within \[six-months\] preceding the study

Sponsors & Collaborators

• University of Minnesota: lead
• Cerebral Palsy International Research Foundation: collaborator
• Foundation for Physical Therapy, Inc.: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (2)

• 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.

  PMID: 26558386 BACKGROUND

• 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.

  PMID: 30471965 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Paresis; Stroke

Interventions

Transcranial Direct Current Stimulation; Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Bernadette Gillick
• Organization: University of Minnesota

gillick@umn.edu

612-626-6415

Study Officials

• Bernadette T Gillick, PhD, MSPT, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 26, 2014
• Study Start: December 31, 2014
• Primary Completion: June 28, 2017
• Study Completion: July 10, 2017
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Locations

US (2)