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Neuromodulation for Post-Traumatic Stress Disorder

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trigeminal Nerve Stimulation
Placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Trigeminal Nerve Stimulation, Post-Traumatic Stress Disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • VA PTSD Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham

Active

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Treatment efficacy as measured by change in Clinician-Administered Post Traumatic Stress Disorder score for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition at baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 80. Higher scores indicate a worse outcome and lower scores indicate better outcome.

Secondary Outcome Measures

Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores.
Secondary outcome measures will be the change in Beck Depression Inventory-II scores from Baseline to Week 8. This is a 21-item scale with maximum and minimum scores ranging from 0 to 63. Higher scores indicate a worse outcome and lower scores indicate a better outcome. For examination of change scores, baseline represents the scores at the time of the second baseline visit (immediately prior to the start of treatment). The endpoint for comparison to baseline will be the week 8 time point or the last non-missing observation during the double-blind treatment.

Full Information

First Posted
November 17, 2014
Last Updated
May 17, 2022
Sponsor
University of California, Los Angeles
Collaborators
VA Greater Los Angeles Healthcare System, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02377089
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
VA Greater Los Angeles Healthcare System, United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Trigeminal Nerve Stimulation, Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
The stimulators are the same device for the active and sham treatment conditions.
Arm Title
Active
Arm Type
Active Comparator
Arm Description
The stimulators are the same device for the active and sham treatment conditions.
Intervention Type
Device
Intervention Name(s)
Trigeminal Nerve Stimulation
Other Intervention Name(s)
TNS
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Treatment efficacy as measured by change in Clinician-Administered Post Traumatic Stress Disorder score for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition at baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 80. Higher scores indicate a worse outcome and lower scores indicate better outcome.
Time Frame
8 weeks (Baseline visit and Week 8 visit)
Secondary Outcome Measure Information:
Title
Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores.
Description
Secondary outcome measures will be the change in Beck Depression Inventory-II scores from Baseline to Week 8. This is a 21-item scale with maximum and minimum scores ranging from 0 to 63. Higher scores indicate a worse outcome and lower scores indicate a better outcome. For examination of change scores, baseline represents the scores at the time of the second baseline visit (immediately prior to the start of treatment). The endpoint for comparison to baseline will be the week 8 time point or the last non-missing observation during the double-blind treatment.
Time Frame
8 weeks ((Baseline visit and Week 8 visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 21-65 years old and be a patient in the Post Traumatic Stress Disorder(PTSD) Clinic at the Veterans Affair Greater Los Angeles have experienced trauma while serving in a war zone in Iraq or Afghanistan 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 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 consent to be randomized to active or sham Trigeminal Nerve Stimulation treatment 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: current substance abuse not in remission for at least 3 months a history of bipolar, schizophrenia, other psychotic disorder, or dementia current suicidal or homicidal ideation requiring hospitalization, or suicide attempt within six months 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) 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 evidence of receiving psychosocial or medication treatment through a clinic or facility other than the VA GLA PTSD Clinic. infection or loss of integrity of skin over the forehead, where the electrode pads will be placed.
Facility Information:
Facility Name
VA PTSD Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

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Neuromodulation for Post-Traumatic Stress Disorder

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