Summary

Eligibility
for people ages 21-65 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Andrew F. Leuchter (ucla)

Description

Summary

The investigators propose to use a clinical trial to test Trigeminal Nerve Stimulation (TNS) to examine the efficacy of TNS as a new treatment for PTSD in veterans. Recruitment will take place at the PTSD Outpatient Clinic at the VA GLA. Study participants will be asked to complete, at most, 9 assessments/questionnaires regarding their PTSD symptoms and quality of life, use the TNS device every night for 8 hours, log their use of the device, and attend weekly visits to monitor safety and complete assessments. Each subject will be asked to attend 8 visits over the course of 8 weeks. Subjects who receives the sham-controlled treatment will have an additional follow-up phone visit 4 weeks after the week 8 endpoint to examine symptom improvements. Enrollment and subject-related procedures are projected to take approximately 36 months. Preparations for clinical trial, clinical trial/study procedures and data analysis will occupy a 6 month period, a 36 month period, and a 6 month period, respectively. The duration of this project is approximately 4 years.

Official Title

Neuromodulation as a New Treatment for Post-Traumatic Stress Disorder in Veterans: Evaluating the Effectiveness of Trigeminal Nerve Stimulation

Keywords

Post-Traumatic Stress Disorder Trigeminal Nerve Stimulation Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Eligibility

You can join if…

Open to people ages 21-65

  1. 21-65 years old and be a patient in the PTSD Clinic at the VA GLA
  2. have experienced trauma while serving in a war zone in Iraq or Afghanistan
  3. meet DSM-IV criteria for current warzone-related PTSD with a duration of at least 3 months
  4. have completed a course of PE therapy in the Resident Psychotherapy Program in the PTSD Clinic within six months of enrollment and with significant residual PTSD symptoms as evidenced by a CAPS score >50
  5. consent to be randomized to active or sham TNS treatment
  6. if receiving medication for depression, anxiety, sleep, or mood stabilization, must have been on stable dose for at least six weeks prior to randomization.

You CAN'T join if...

  1. current substance abuse not in remission for at least 3 months
  2. a history of bipolar, schizophrenia, other psychotic disorder, or dementia
  3. current suicidal or homicidal ideation requiring hospitalization, or suicide attempt within six months
  4. report of severe TBI with coma duration (30 minutes or more) during the screening interview and/or duration of post - traumatic amnesia (1hour or greater) on the Post-traumatic Amnesia Questionnaire (PTAQ)
  5. evidence of receiving antidepressant, antianxiety, antipsychotic, or mood-stabilizer medication where the dose has not been stable for a minimum of six weeks prior to entering the randomization
  6. evidence of receiving psychosocial or medication treatment through a clinic or facility other than the VA GLA PTSD Clinic.
  7. infection or loss of integrity of skin over the forehead, where the electrode pads will be placed.

Location

  • VA PTSD Clinic
    Los Angeles California 90073 United States

Lead Scientist at University of California Health

  • Andrew F. Leuchter (ucla)
    Department Vice Chair, Psychiatry and Biobehavioral Sciences, Psychiatry and Biobehavioral Sciences. Authored (or co-authored) 114 research publications.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT02377089
Study Type
Interventional
Last Updated