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NCT01335217 · ClinicalTrials.gov registry record · Phase 1
Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression
A Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01335217: Completed Phase 1 study, sponsored by University of California, Los Angeles.
NCT01335217 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335217, a Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary objective is the examination of TNS in this patient population. To accomplish our specific aims, the investigators will test the following specific hypotheses: 1. Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period. 2. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS. 3. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
Interventions
- PROCEDURE Transcutaneous Electrical Nerve Stimulator (TENS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT01335217 record still lists
NCT01335217 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Transcutaneous Electrical Nerve Stimulator (TENS) is the first listed.
NCT01335217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01335217 about?
NCT01335217 is a clinical study titled "Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression". This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary object...
What is the current status of trial NCT01335217?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-01. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01335217?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulator (TENS) (PROCEDURE).
Who is sponsoring clinical trial NCT01335217?
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 NCT01335217's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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