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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: Completed NA study, sponsored by University of Minnesota.

NCT02250092 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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

Interventions

  • DEVICE Transcranial Direct Current Stimulation (tDCS)
  • DEVICE Placebo Comparator

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2014-12-31
Est. Completion 2017-07-10
Phase NA
University of Minnesota

966 total trials

What the finished NCT02250092 record still lists

NCT02250092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Transcranial Direct Current Stimulation (tDCS) is the first listed.

NCT02250092 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02250092's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02250092, the US trial registry maintained by the National Library of Medicine. NCT02250092 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.