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NCT01636661 · ClinicalTrials.gov registry record · Early Phase 1
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
A Early Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
NCT01636661: Completed Early Phase 1 study, sponsored by University of Minnesota.
NCT01636661 is a Early Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 13 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01636661, a Early Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis. The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses: 1. tDCS will not produce a major adverse event, including seizure activity. 2. No change in paretic or nonparetic hand function or cognitive status will occur.
Primary Outcome
Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria: 1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. 2. Physician Evaluation- Child identified as declining in function from pretest to posttest. 3. Subject Report of Symptoms- Reports of serious adverse event/
Interventions
- DEVICE tDCS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-12 |
| Phase | Early Phase 1 |
What the finished NCT01636661 record still lists
NCT01636661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which tDCS is the first listed.
NCT01636661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01636661 about?
NCT01636661 is a clinical study titled "Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis". The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis. The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypothes...
What is the current status of trial NCT01636661?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2012-07. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01636661?
The interventions under investigation include: tDCS (DEVICE).
Who is sponsoring clinical trial NCT01636661?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01636661's enrollment target sits among peer trials
13 1504th of 2000 higher than 472 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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