Vagus Nerve Stimulation + PEPC for Fibromyalgia and PTSD
(SWIFT-RELIEVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Fibromyalgia (FM) pain and PTSD are highly prevalent and comorbid with associated increased risk of negative physical and mental health outcomes, including higher risk for opioid use and suicide. This project is designed to determine the effects of a 4 week trial of a device for pain management \[transauricular vagus nerve stimulation (taVNS)\] on pain interference and intensity \[Pain, Enjoyment, and Activity General Scale (PEG)\] and PTSD. The investigators will also examine how this impacts the Veterans by examining heart rate variability (HRV) as a stress response related biomarker. The investigators plan to randomize 180 Veterans (estimate up to 360 enrolled) with co-morbid FM and PTSD across pain integrated care and PTSD sites in this prospective study and compare: 1) active taVNS for pain + Prolonged Exposure in Primary Care (PE-PC) and 2) sham taVNS + PE-PC. Study includes 4 weeks of randomized treatment and 4 weeks of voluntary open label treatment. Veterans are assessed (self report \& interview measures, heart rate variability by wearable device) at Intake, Baseline/Post Run-In, Week 2, Week 4, Week 8 and 4 month follow-up. The investigators plan to retain data after the study for potential future use in research.
Who Is on the Research Team?
Anna Woodbury, MD
Principal Investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Sheila A.M. Rauch, PhD
Principal Investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Are You a Good Fit for This Trial?
This trial is for English-speaking Veterans with both fibromyalgia and PTSD, confirmed by specific questionnaires and pain scores. Participants must have stable medication use, not be pregnant or breastfeeding, and cannot have severe mental health issues, recent substance abuse, or other major medical problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham transauricular vagus nerve stimulation (taVNS) combined with Prolonged Exposure in Primary Care (PE-PC) for 4 weeks
Open-label extension
Participants may opt into continuation of active taVNS treatment for an additional 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of pain and PTSD symptoms
What Are the Treatments Tested in This Trial?
Interventions
- Prolonged Exposure in Primary Care (PE-PC)
- Transauricular Vagus Nerve Stimulation (taVNS)
Trial Overview
The study compares a device that stimulates the vagus nerve through the ear (taVNS) plus talk therapy (PE-PC) to a sham (inactive) device plus the same therapy. Treatment lasts 4 weeks with follow-up assessments up to 4 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Transauricular vagus nerve stimulation (taVNS) provided for 2 hours per day for weeks. Frequency: 25 Hz on inner region (ABVN), 100Hz on outer region (ATN), Pulse width: 250 µs, Duty cycle: 5 minutes on, 10 second off. Stimulation is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.
Sham will use the same device and schedule with a brief individualized suprasensory stimulation followed by a ramp down over 2 minutes. Sham is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
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