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NCT01388530 · ClinicalTrials.gov registry record · Early Phase 1
Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
A Early Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
NCT01388530: Completed Early Phase 1 study, sponsored by University of California, Los Angeles.
NCT01388530 is a Early Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 25 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01388530, a Early Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.
Primary Outcome
A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms. Scale ranges from 0 (best) to 54 (worst). Unit of Measure - units on a scale. Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS.
Interventions
- DEVICE EMS 7500 Digital Muscle Stimulator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-12 |
| Phase | Early Phase 1 |
What the finished NCT01388530 record still lists
NCT01388530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which EMS 7500 Digital Muscle Stimulator is the first listed.
NCT01388530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01388530 about?
NCT01388530 is a clinical study titled "Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)". This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federa...
What is the current status of trial NCT01388530?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2011-07. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01388530?
The interventions under investigation include: EMS 7500 Digital Muscle Stimulator (DEVICE).
Who is sponsoring clinical trial NCT01388530?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01388530's enrollment target sits among peer trials
25 1000th of 2000 higher than 964 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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