Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC (NCT07718984)
SWIFT-RELIEVE : Simultaneous Treatment of Widespread Pain In Fibromyalgia and PTSD: Randomized Evaluation of Live vs. Inactive Electrical VNS With PE-PC
🩺 Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia
📞 Contact the Study Coordinator
Phone: (404) 621-3122
Email: Sheila.Rauch@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Fibromyalgia (FM)
- Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia — Pittsburgh, Pennsylvania
- Personalized Ultrasonic Brain Stimulation for Fibromyalgia — Salt Lake City, Utah
- Investigating the Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Brain in People With Fibromyalgia — Rochester, New York
Explore by condition: All Fibromyalgia (FM) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.