Brain Stimulation and Hand Training in Children With Hemiparesis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02250092|
Recruitment Status : Active, not recruiting
First Posted : September 26, 2014
Last Update Posted : January 30, 2018
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)
|Condition or disease||Intervention/treatment|
|Pediatric Hemiparesis||Device: Transcranial Direct Current Stimulation (tDCS) Device: Placebo Comparator|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Synergistic Effect of Combined Transcranial Direct Current Stimulation/Constraint Induced Movement Therapy in Children With Hemiparesis|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
Active Comparator: tDCS/CIMT
Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.
Device: Transcranial Direct Current Stimulation (tDCS)
10 tDCS/CIMT Sessions
Placebo Comparator: tDCS sham/CIMT
Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT.
|Device: Placebo Comparator|
- Assisting Hand Assessment [ Time Frame: Baseline, 2 weeks and 6 months ]Videotaped performance during a bimanual age-appropriate activity of change from baseline to posttest and followup sessions of bimanual performance using an assessment of assisting hand performance during bimanual activities.
- Canadian Occupational Performance Measurement [ Time Frame: Baseline, 2 weeks and 6 months ]Subject survey tool of change from baseline to posttest and followup sessions by participant declaration of goals with assessment of personal satisfaction and performance compared to baseline.
- Subject Symptom Assessment [ Time Frame: Baseline, 2 weeks and 6 months ]Questionnaire- Assessment of change from baseline to during-session-posttest and follow up using a detailed assessment of subject symptoms as relate to behavioral and non-invasive brain stimulation interventions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250092
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Gillette Children's Specialty Healthcare|
|Saint Paul, Minnesota, United States, 55101|
|Principal Investigator:||Bernadette T Gillick, PhD, MSPT, PT||University of Minnesota - Clinical and Translational Science Institute|