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NCT02250092 · ClinicalTrials.gov registry record · NA
Brain Stimulation and Hand Training in Children With Hemiparesis
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT02250092 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 20 participants.
The verdict
NCT02250092, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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 randomizati
Interventions
- DEVICE Transcranial Direct Current Stimulation (tDCS)
- DEVICE Placebo Comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-12-31 |
| Est. Completion | 2017-07-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02250092
The ClinicalTrials.gov registry entry for NCT02250092 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Transcranial Direct Current Stimulation (tDCS) is the first listed.
NCT02250092 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02250092 about?
NCT02250092 is a clinical study titled "Brain Stimulation and Hand Training in Children With Hemiparesis". 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. ...
What is the current status of trial NCT02250092?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2014-12-31. Estimated completion is 2017-07-10.
What interventions are being tested in trial NCT02250092?
The interventions under investigation include: Transcranial Direct Current Stimulation (tDCS) (DEVICE), Placebo Comparator (DEVICE).
Who is sponsoring clinical trial NCT02250092?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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