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

NCT07718984 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: RRDA-009-25W1-I01-RD-000404-01-A2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia (FM); Posttraumatic Stress Disorder (PTSD)

Keywords

fibromyalgia; post-traumatic stress disorder; pain; heart rate variability; vagus nerve stimulation; treatment

Outcome Measures

Primary Outcomes (3)

• Pain Intensity [Pain, Enjoyment, and General Activity Scale (PEG)]

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

  Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup

• Pain Interference with Enjoyment [Pain, Enjoyment, and General Activity Scale (PEG)]

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

  Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup

• Pain Interference with Activity [Pain, Enjoyment, and General Activity Scale (PEG)]

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

  Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup

Secondary Outcomes (1)

• PTSD Checklist for DSM 5 (PCL-5)

  Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup

Study Arms (2)

taVNS plus PEPC

EXPERIMENTAL

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.

Device: taVNS plus PEPC

Sham plus PEPC

SHAM COMPARATOR

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.

Device: sham plus PEPC

Interventions

taVNS plus PEPC DEVICE

The research version of Spark's Sparrow Ascent for vagus nerve stimulation provided through a sticker that attaches to the ear. This device allows the patient to self apply the device in a home setting. It is FDA cleared and available in VA. Stimulation is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.

Also known as: Sparrow Link

taVNS plus PEPC

sham plus PEPC DEVICE

Same device as active condition but programmed with sham parameters including suprasensory stimulation followed by ramp down. Sham is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.

Also known as: Sparrow Link

Sham plus PEPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be any era Veterans reporting FM and 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 \[94\]
• 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 \[4-month follow-up visit\]

You may not qualify if:

• Subjects must not have other primary clinical issues that would interfere with FM or PTSD treatment such as recent stroke or severe heart disease
• 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 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 be currently receiving talk therapy for trauma-related symptoms or FM
• Subjects must not be currently pregnant or lactating given risk of pre-term labor and interference of oxytocin with VNS effects

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Stress Disorders, Post-Traumatic; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sheila A.M. Rauch, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

• Anna Woodbury, MD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila A Rauch, PhD

CONTACT

(404) 621-3122; Sheila.Rauch@va.gov

Anna Woodbury, MD

CONTACT

(404) 321-6111; Anna.Woodbury@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All are blind except for the one study team member who is not involved in care who programs the device for the assigned condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Veterans are randomly assigned to receive active or sham taVNS for the treatment phase (4 weeks) and then all Veterans are allowed to receive active taVNS for 4 weeks All veterans receive PEPC for the first 4 weeks.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon publication if required and after publication of all primary statement of work analyses upon appropriate request.
• Access Criteria: Data will available from request to the principal investigator after all publications are released.

Locations

US (1)