Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC | NCT07718984

NCT07718984

Overview

NCT ID: NCT07718984
Lead Sponsor: VA Office of Research and DevelopmentFED
Official Title: SWIFT-RELIEVE : Simultaneous Treatment of Widespread Pain In Fibromyalgia and PTSD: Randomized Evaluation of Live vs. Inactive Electrical VNS With PE-PC
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jan 1, 2027Estimated
Primary Completion Date: Dec 31, 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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]

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 180Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Sheila A Rauch, PhDContact
Sheila.Rauch@va.gov(404) 621-3122 ext. 3122

Similar Studies

Participant Group/Arms

taVNS plus PEPCExperimental

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 PEPCSham 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