Neuromodulation for Post-Traumatic Stress Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 2/8/2019 |
| Start Date: | May 2015 |
| End Date: | October 1, 2019 |
| Contact: | Michelle Abrams, RN |
| Phone: | 3108250797 |
Neuromodulation as a New Treatment for Post-Traumatic Stress Disorder in Veterans: Evaluating the Effectiveness of Trigeminal Nerve Stimulation
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 PTSD in veterans. Recruitment will take
place at the PTSD Outpatient Clinic at the 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.
to examine the efficacy of TNS as a new treatment for PTSD in veterans. Recruitment will take
place at the PTSD Outpatient Clinic at the 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.
Inclusion Criteria:
1. 21-65 years old and be a patient in the PTSD Clinic at the VA GLA
2. have experienced trauma while serving in a war zone in Iraq or Afghanistan
3. meet DSM-IV criteria for current warzone-related PTSD with a duration of at least 3
months
4. have completed a course of 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 CAPS score >50
5. consent to be randomized to active or sham TNS 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 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.
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