NCT06415591 Auricular Neuromodulation in Veterans With Fibromyalgia
| NCT ID | NCT06415591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2024-11-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
PENFS (percutaneous electrical nerve field stimulation) is an FDA-cleared acupuncture-like therapy applied to the external ear targeting several cranial nerve branches including the auricular branch of the vagus nerve to improve pain, physical function, and reduce symptoms of opioid withdrawal. PENFS has been previously shown to provide improvements in fibromyalgia, a difficult to treat chronic pain syndrome, which correlate with changes observed using a special kind of MRI called resting state functional connectivity MRI (rs-fcMRI) that evaluates brain activity at rest. The goals of this study are to rigorously test the initial promising results of PENFS in a much larger group of Veterans suffering from fibromyalgia and to identify potential mechanisms of PENFS effects. Further developing non-pharmacologic therapies for pain can help to improve quality of life and function for those suffering from fibromyalgia and decrease reliance on opioids and other drugs that have numerous side effects for individuals suffering from chronic pain.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older; for those who participate in the MRI portion, age 20-60 years old (limit specifically set for participants receiving an MRI scan; limit set to minimize brain structural changes due to aging) * For those who participate in the MRI portion, right-handedness, to provide consistency in brain structure and function (limit specifically set for participants receiving an MRI scan; limit set to minimize brain structural changes due to aging) * For those who participate in the MRI portion, the ability to safely tolerate MRI * Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria69 * Pain score of 4 or greater on DVPRS51 in the 3 months prior to enrollment * Intact skin in area of PENFS treatment Exclusion Criteria: * Pregnancy (self-reported) * History of seizures or neurologic conditions that alter the brain * Claustrophobia, MRI-incompatible implants, or other conditions incompatible with MRI (only for those who participate in MRI) * History of uncontrolled psychiatric illness, autoimmune disease that leads to pain, or skin conditions that can increase risk of infection at PENFS site
Contact & Investigator
Anna Woodbury, MD
PRINCIPAL INVESTIGATOR
Atlanta VA Medical and Rehab Center, Decatur, GA
Frequently Asked Questions
Who can join the NCT06415591 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06415591 currently recruiting?
Yes, NCT06415591 is actively recruiting participants. Contact the research team at Anna.Woodbury@va.gov for enrollment information.
Where is the NCT06415591 trial being conducted?
This trial is being conducted at Decatur, United States.
Who is sponsoring the NCT06415591 clinical trial?
NCT06415591 is sponsored by VA Office of Research and Development. The principal investigator is Anna Woodbury, MD at Atlanta VA Medical and Rehab Center, Decatur, GA. The trial plans to enroll 240 participants.
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