Recruiting

Auricular Neuromodulation

Sponsor:

VA Office of Research and Development

Code:

NCT06415591

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Percutaneous electrical nerve field stimulation

Study Details

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.

Conditions

Fibromyalgia

Study ID

NCT06415591

Start date

Nov 1, 2024

Status verified date

May, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: True PENFS

Percutaneous electrical nerve stimulation applied to the ear x 4 over a 4 week period. The device is placed over the area of the ear and worn home continuously for a 5-day period, during which time it stimulates at a pre-set on/off duty cycle. At each in-person visit, the device is replaced until the device has been placed 4 times. The stimulation delivered is below the threshold of sensory perception.

sham comparator: Sham PENFS

A device is placed at the same points for the same amount of time and at the same intervals as the true device. This device will not deliver electrical stimulation.

Interventions

Percutaneous electrical nerve field stimulation

FDA-approved 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.

Primary outcome measure

  • Improvements in Clinical Pain (DVPRS) [ Time Frame: Through study completion, an average of 1 year ]
  • Improvements in Clinical Pain (Self-reported analgesic consumption) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Anna Woodbury, MD

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

Anna M Ree, BA

(404) 321-6111anna.ree@va.gov

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Anna Woodbury, MD

404-321-6111Anna.Woodbury@va.gov

Principal Investigator:

Anna Woodbury, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Pain
  • Fibromyalgia
  • Magnetic Resonance Imaging
  • Veterans
  • Percutaneous Electrical Nerve Field Stimulation
  • Vagus Nerve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-22.