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NCT02481765 · ClinicalTrials.gov registry record · NA
Feasibility and Dose Tolerability of HD-tDCS in Healthy Adults and Children With Down Syndrome
A NA study of Down Syndrome, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT02481765: Completed NA study of Down Syndrome, sponsored by University of Wisconsin, Madison.
NCT02481765 is a NA study of Down Syndrome that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 5 participants, below the 2,472-participant average among 54 other Down Syndrome trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02481765, a NA study of Down Syndrome, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
Transcranial direct current stimulation (tDCS) is a method which enables noninvasive electrical stimulation of the cortex via electrodes placed on the subject's skull. High definition tDCS (HD-tDCS) allows for precise generation of electrical fields over selected cortical areas using multiple electrodes. The purpose of this pilot trial is to study feasibility, tolerability, and safety of HD-tDCS administered daily for a total of 20 sessions in healthy adults and 5-10 year old children with Down syndrome. PRIMARY OBJECTIVES Part I: To assess feasibility and tolerability of HD-tDCS, administered up to 5 days per week for a total of 20 sessions in healthy adult subjects; Part II: After review of the safety data for Part I is completed and reviewed by the Data Safety Monitoring Committee and IRB, Part II will be initiated. To assess feasibility and tolerability of HD-tDCS, administered up to 5 days per week for a total of 20 sessions in adult subjects with Down Syndrome.
Primary Outcome
To assess feasibility and tolerability of HD-tDCS, administered up to 5 days per week for a total of 20 sessions in healthy adult subjects; Part I will be defined to be positive if 5 healthy adults are accrued within the study period (12 months) and 4 of 5 participants (80%) have successful completion.
Conditions Studied
Interventions
- DEVICE High definition transcranial direct current stimulation
Study Locations (1)
Wisconsin
- Department of Neurology, University of Wisconsin Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-09-15 |
| Est. Completion | 2016-05-20 |
| Phase | NA |
What the finished NCT02481765 record still lists
NCT02481765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 2,472-participant average among 54 other Down Syndrome trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Down Syndrome appearing as the primary indexed condition, and to 1 intervention - of which High definition transcranial direct current stimulation is the first listed.
NCT02481765 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02481765 about?
NCT02481765 is a clinical study titled "Feasibility and Dose Tolerability of HD-tDCS in Healthy Adults and Children With Down Syndrome". Transcranial direct current stimulation (tDCS) is a method which enables noninvasive electrical stimulation of the cortex via electrodes placed on the subject's skull. High definition tDCS (HD-tDCS) allows for precise generation of electrical fields over selected cortical areas using multiple electr...
What is the current status of trial NCT02481765?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2015-09-15. Estimated completion is 2016-05-20.
What conditions does trial NCT02481765 study?
This clinical trial studies the following conditions: Down Syndrome.
What interventions are being tested in trial NCT02481765?
The interventions under investigation include: High definition transcranial direct current stimulation (DEVICE).
Who is sponsoring clinical trial NCT02481765?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02481765 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02481765's enrollment target sits among peer trials
5 55th of 54 the lowest of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome 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.
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