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Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression

NCT01335217 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-02-06

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Transcutaneous Electrical Nerve Stimulator (TENS)

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

Sponsors & Collaborators

Principal Investigators

  • Ian A Cook, M.D. · Semel Institute for Neuroscience and Human Behavior

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335217 on ClinicalTrials.gov