Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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
Trial design
Design model
Parallel
Treatments tested in this trial
tAN plus PEPC
DeviceThe research version of Spark's Sparrow Ascent for vagus and trigeminal 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.
sham plus PEPC
DeviceSame 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: taVNS plus PEPCExperimental treatment 1 intervention
Group B: Sham plus PEPCSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup2
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).
Time frame
Intake, Baseline, Week 2, Week 4, Week 8, 4 month followup3
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).
Time frame
Intake, Baseline, Week 2, Week 4, Week 8, 4 month followupSecondary outcomes
1
Post-traumatic stress disorder (PTSD) Checklist for DSM 5 (PCL-5)
Total sum of each of 20 items covering PTSD symptom ratings for the past week each scored on a 0 (not al all) to 4 (extremely) scale. Total score ranges from 0 to 80.
Time frame
Intake, Baseline, Week 2, Week 4, Week 8, 4 month followupSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: