Post-Traumatic Stress Disorder
Conditions
Keywords
Trigeminal Nerve Stimulation, Post-Traumatic Stress Disorder
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.
Interventions
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.
DEVICEPlacebo
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.
Sponsors
VA Greater Los Angeles Healthcare System
United States Department of Defense
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | 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(DSM-V) at Baseline and Week 8 Visit | 8 weeks (Baseline visit 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores. | 8 weeks ((Baseline visit and Week 8 visit) | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment at the VA Greater Los Angeles and VA Long Beach.
Pre-assignment details
95 Potential participants were assessed for eligibility, of the 95, 23 participants did not meet the study criteria, and 72 participants were consented for the study. Of the 72 consented participants, 12 subjects dropped prior to randomization resulting in 60 randomized, evaluable participants.
Participants by arm
| Arm | Count |
|---|---|
| Sham The stimulators are the same device for the active and sham treatment conditions.
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. | 31 |
| Active The stimulators are the same device for the active and sham treatment conditions.
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. | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | Active | Total | Sham |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 60 Participants | 31 Participants |
| Age, Continuous | 35.57 years | 37.71 years | 41.33 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 29 Participants | 60 Participants | 31 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 58 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 0 / 31 | 1 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
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.
Time frame: 8 weeks (Baseline visit and Week 8 visit)
Population: Discrepancy in subjects randomized and subjects analyzed reflect the number of subjects who were randomized but discontinued intervention prior to reaching an evaluable time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham | 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 | Baseline | 50.60 score on a scale | Standard Deviation 6.83 |
| Sham | 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 | Week 8 | 28.29 score on a scale | Standard Deviation 14.74 |
| Active | 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 | Baseline | 50.10 score on a scale | Standard Deviation 7.77 |
| Active | 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 | Week 8 | 28.61 score on a scale | Standard Deviation 12.99 |
Secondary
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.
Time frame: 8 weeks ((Baseline visit and Week 8 visit)
Population: Discrepancy in subjects randomized and subjects analyzed reflect the number of subjects who were randomized but discontinued intervention prior to reaching an evaluable time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham | Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores. | Baseline | 28.29 score on a scale | Standard Deviation 9.41 |
| Sham | Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores. | Week 8 | 15.36 score on a scale | Standard Deviation 9.28 |
| Active | Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores. | Baseline | 28.31 score on a scale | Standard Deviation 9.43 |
| Active | Treatment Efficacy as Measured by Change in Score on Beck Depression Inventory-II Assessment Scores. | Week 8 | 15.78 score on a scale | Standard Deviation 12.55 |