Neuromodulation for Post-Traumatic Stress Disorder

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT02377089
Collaborator
VA Greater Los Angeles Healthcare System (U.S. Fed), United States Department of Defense (U.S. Fed)
72
1
2
77.7
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Trigeminal Nerve Stimulation
  • Device: Placebo
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Neuromodulation as a New Treatment for Post-Traumatic Stress Disorder in Veterans: Evaluating the Effectiveness of Trigeminal Nerve Stimulation
Actual Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Oct 20, 2020
Actual Study Completion Date :
Oct 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham

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

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.

Active Comparator: Active

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

Device: 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.
Other Names:
  • TNS
  • Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA PTSD Clinic Los Angeles California United States 90073

    Sponsors and Collaborators

    • University of California, Los Angeles
    • VA Greater Los Angeles Healthcare System
    • United States Department of Defense

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrew F. Leuchter, Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT02377089
    Other Study ID Numbers:
    • W81XWH-14-2-0125
    First Posted:
    Mar 3, 2015
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Andrew F. Leuchter, Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Recruitment at the VA Greater Los Angeles and VA Long Beach.
    Pre-assignment Detail 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.
    Arm/Group Title Sham Active
    Arm/Group Description 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 Trigeminal Nerve Stimulation (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. The stimulators are the same device for the active and sham treatment conditions. Trigeminal Nerve Stimulation (TNS): 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.
    Period Title: Overall Study
    STARTED 31 29
    COMPLETED 22 24
    NOT COMPLETED 9 5

    Baseline Characteristics

    Arm/Group Title Sham Active Total
    Arm/Group Description 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. 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. Total of all reporting groups
    Overall Participants 31 29 60
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    31
    100%
    29
    100%
    60
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    41.33
    35.57
    37.71
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    2
    6.9%
    2
    3.3%
    Male
    31
    100%
    27
    93.1%
    58
    96.7%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    31
    100%
    29
    100%
    60
    100%

    Outcome Measures

    1. Primary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Sham Active
    Arm/Group Description 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=31 in sham 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. 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=29 in active 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.
    Measure Participants 26 28
    Baseline
    50.60
    (6.83)
    50.10
    (7.77)
    Week 8
    28.29
    (14.74)
    28.61
    (12.99)
    2. Secondary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Sham Active
    Arm/Group Description 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=31 in sham 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. 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=29 in active 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.
    Measure Participants 26 28
    Baseline
    28.29
    (9.41)
    28.31
    (9.43)
    Week 8
    15.36
    (9.28)
    15.78
    (12.55)

    Adverse Events

    Time Frame Adverse event data was collected each weekly assessment visit for every participant, up to 8 weeks
    Adverse Event Reporting Description Serious Adverse events remain at zero as the research treatment administered in this study is categorized as minimal risk and non-significant risk. This indicates an inherent lack of risk for death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, a congenital anomaly/birth defect, or all-cause mortality.
    Arm/Group Title Sham Active
    Arm/Group Description 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. 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.
    All Cause Mortality
    Sham Active
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/31 (0%) 0/29 (0%)
    Serious Adverse Events
    Sham Active
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/31 (0%) 0/29 (0%)
    Other (Not Including Serious) Adverse Events
    Sham Active
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/31 (0%) 1/29 (3.4%)
    Nervous system disorders
    Headache 0/31 (0%) 0 1/29 (3.4%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Andrew F. Leuchter
    Organization UCLA Semel Insititute
    Phone 310-825-0207
    Email afl@ucla.edu
    Responsible Party:
    Andrew F. Leuchter, Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT02377089
    Other Study ID Numbers:
    • W81XWH-14-2-0125
    First Posted:
    Mar 3, 2015
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    May 1, 2022