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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 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 20 participants.

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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

FieldValue
Enrollment Target 20 participants
Start Date 2011-01
Est. Completion 2012-01
Phase Phase 1

What the Registry Record Tells You About NCT01335217

The ClinicalTrials.gov registry entry for NCT01335217 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Transcutaneous Electrical Nerve Stimulator (TENS) is the first listed.

NCT01335217 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.