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Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC

Key facts

Who runs it
VA Office of Research and Development
Where
Decatur, United StatesSee the site
Trial code
Status
Not yet recruiting
People taking part
180 people, planned
Starts
1 Jan 2027
Expected to end
31 Dec 2030
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • tAN plus PEPC
  • sham plus PEPC
Record updated
29 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Subjects must be any era Veterans reporting fibromyalgia (FM) and post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for DSM-5 (PCL-5) ≥ 28; FM confirmed with ACR Diagnostic Criteria and pain score at least 4/10 for 3 months
  • Subjects must speak English
  • If subjects are taking psychotropic medication, 2-weeks on stable dose prior to enrollment and agreement to maintain current medications until after the 4-month follow-up visit

Who cannot take part

  • Subjects must not be currently receiving talk therapy for trauma-related symptoms or fibromyalgia (FM)
  • Subjects must not have other primary clinical issues that would interfere with fibromyalgia (FM) or post-traumatic stress disorder (PTSD) treatment such as recent stroke or severe heart disease
  • Subjects must not have severe cognitive impairment that interferes with PE-PC (unable to retain information in acute interaction)
  • Subjects must not have unmanaged psychosis or bipolar disorder
  • Subjects must not have moderate to severe substance use disorder in the past 8 weeks
  • Subjects must not have a level of suicide risk that requires intervention as determined by item 9 on PHQ-9 with follow-up risk assessment by study staff
  • Subjects must not be currently pregnant or lactating given risk of pre-term labor and interference of oxytocin with vagus nerve stimulation (VNS) effects

Where in United States

  • Atlanta VA Medical and Rehab Center, Decatur, GADecatur, United StatesContact: Sheila A Rauch, PhDNo longer taking part

About the trial

What the trial wants to find out

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 nerve stimulation (tAN)] 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 tAN for pain + Prolonged Exposure in Primary Care (PE-PC) and 2) sham tAN + 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.

The 2 groups in the trial

  • taVNS plus PEPCTreatment being tested

    Transauricular nerve stimulation (tAN) 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.

    Treatment: tAN plus PEPC

  • Sham plus PEPCSham treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
SWIFT-RELIEVE : Simultaneous Treatment of Widespread Pain In Fibromyalgia and PTSD: Randomized Evaluation of Live vs. Inactive Electrical VNS With PE-PC
Record updated
29 September 2026
Under construction, not live – Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC (NCT07718984) – Frontlight Research