Neuromodulation for Post-Traumatic Stress Disorder

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Post-Traumatic Stress Disorder

Treatments: Device: Placebo; Device: Trigeminal Nerve Stimulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02377089

W81XWH-14-2-0125

Details and patient eligibility

About

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 Post Traumatic Stress Disorder (PTSD) in veterans. Recruitment will take place at the PTSD Outpatient Clinic at the Veterans Affair Greater Los Angeles (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.

Enrollment: 72 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 21-65 years old and be a patient in the Post Traumatic Stress Disorder(PTSD) Clinic at the Veterans Affair Greater Los Angeles
2. have experienced trauma while serving in a war zone in Iraq or Afghanistan
3. meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for current war zone-related PTSD with a duration of at least 3 months
4. have completed a course of Prolonged Exposure(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 Clinician-Administered PTSD Scale score >50
5. consent to be randomized to active or sham Trigeminal Nerve Stimulation 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.

Exclusion criteria

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 Traumatic Brain Injury (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Sham

Sham Comparator group

Description:

The stimulators are the same device for the active and sham treatment conditions.

Treatment:

Device: Placebo

Active

Active Comparator group

Description:

The stimulators are the same device for the active and sham treatment conditions.

Treatment:

Device: Trigeminal Nerve Stimulation