Neuromodulation for Post-Traumatic Stress Disorder

NCT ID: NCT02377089

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-10-20

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.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham

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

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DEVICE

Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.

Active

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

Group Type: ACTIVE_COMPARATOR

Trigeminal Nerve Stimulation

Intervention Type: DEVICE

Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.

Interventions

Trigeminal Nerve Stimulation

Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.

Intervention Type: DEVICE

Placebo

Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.

Intervention Type: DEVICE

Other Intervention Names

TNS

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Greater Los Angeles Healthcare System

FED

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Andrew F. Leuchter

Professor of Psychiatry and Biobehavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA PTSD Clinic

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W81XWH-14-2-0125

Identifier Type: -

Identifier Source: org_study_id