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Fibromyalgia and PTSD Treatment with Vagus Nerve Stimulation

This study is investigating if combining a device called Spark's Sparrow Ascent (transauricular vagus nerve stimulation or taVNS) with a type of therapy called Processing Emotions in Primary Care (PEPC) can help Veterans with both fibromyalgia (FM) and post-traumatic stress disorder (PTSD). The taVNS device is applied to the ear and can be used at home. Researchers want to see if this combination improves pain intensity, how much pain interferes with enjoyment and activities, and PTSD symptoms. You may be eligible if you are a Veteran aged 18 or older, speak English, and have symptoms of both FM and PTSD. The study aims to enroll 180 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 180 participants. Participants will receive either the active taVNS device plus PEPC therapy, or a sham (inactive) device plus PEPC therapy.
What's involved
Participants will have 6, 30-minute sessions of PEPC therapy over 4 weeks. They will also self-apply the taVNS or sham device at home.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for pain intensity and interference at Intake, Baseline, Week 2, Week 4, Week 8, and a 4-month follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07718984

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~180 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:taVNS plus PEPCsham plus PEPC

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Intensity [Pain, Enjoyment, and General Activity Scale (PEG)]
Measured over Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup
+2 more outcomes measured

Conditions

Fibromyalgia (FM)
Posttraumatic Stress Disorder (PTSD)

Explore related trials

FibromyalgiaPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Sheila A.M. Rauch, PhD · PRINCIPAL_INVESTIGATOR · Atlanta VA Medical and Rehab Center, Decatur, GA
  • Anna Woodbury, MD · PRINCIPAL_INVESTIGATOR · Atlanta VA Medical and Rehab Center, Decatur, GA

Who to contact

Sheila A Rauch, PhD
[email protected]
(404) 621-3122 · ext. 3122
Email the study team

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What this trial measures

  • Pain Intensity [Pain, Enjoyment, and General Activity Scale (PEG)]Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup

    Single item rating past week average intensity of pain on a scale from 0 (none) to 10 (As bad as I can imagine)

  • Pain Interference with Enjoyment [Pain, Enjoyment, and General Activity Scale (PEG)]Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup

    Single item rating of average pain interference with enjoyment of life over the past week on a 0 (no interference) to 10 (completely interfered).

  • Pain Interference with Activity [Pain, Enjoyment, and General Activity Scale (PEG)]Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup

    Single item rating of average pain interference in general activity over the past week on a 0 (no interference) to 10 (completely interfered).