Clinical trial NCT02377089: Neuromodulation for Post-Traumatic Stress Disorder
Official title: Neuromodulation as a New Treatment for Post-Traumatic Stress Disorder in Veterans: Evaluating the Effectiveness of Trigeminal Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Trigeminal Nerve Stimulation
Post-Traumatic Stress Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: VA Greater Los Angeles Healthcare System
name: United States Department of Defense
First posted: 2015-03-03
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Efficacy as Measured by Change in Clinician-Administered Post Traumatic Stress Disorder Score for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition(DSM-V) at Baseline and Week 8 Visit
timeFrame: 8 weeks (Baseline visit and Week 8 visit)
Secondary outcomes:
measure: Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores.
timeFrame: 8 weeks ((Baseline visit and Week 8 visit)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA PTSD Clinic
state: California
Study officials:
References: