Ear nerve stimulation for veterans with fibromyalgia
Auricular Neuromodulation in Veterans with Fibromyalgia: A Randomized, Sham-Controlled Study
['FUNDING_OTHER'] · VETERANS HEALTH ADMINISTRATION · NIH-11219224
This tests whether a small electrical device placed on the ear can reduce pain and improve daily function for veterans with fibromyalgia.
Quick facts
| Phase | ['FUNDING_OTHER'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | VETERANS HEALTH ADMINISTRATION (nih funded) |
| Locations | 1 site (Decatur, UNITED STATES) |
| Trial ID | NIH-11219224 on ClinicalTrials.gov |
What this research studies
You would be a veteran with fibromyalgia who is randomly assigned to get either a real ear nerve stimulation device or a sham (placebo) device, and neither you nor the study team treating you will know which one you received. Treatment effects will be tracked over time using pain and function measures, heart rate variability to look at vagal (autonomic) changes, and brain imaging (resting-state fMRI) as a biomarker. The team previously ran a small feasibility VA study that showed trends toward sustained pain and function benefits, so this larger, double-blind, sham-controlled trial will test those findings more rigorously. Follow-up continues for weeks after treatment to see how long any benefits last.
Who could benefit from this research
Good fit: Ideal candidates are veterans diagnosed with fibromyalgia who can attend visits at the VA site and agree to undergo device treatment, heart rate monitoring, and brain imaging.
Not a fit: People without fibromyalgia, non-veterans, or those who cannot undergo MRI or the nerve stimulation procedure are unlikely to qualify or benefit from this trial.
Why it matters
Potential benefit: If successful, this could offer a non-drug way to reduce fibromyalgia pain and improve function, potentially lowering reliance on opioids.
How similar studies have performed: Small, earlier VA-funded work found promising trends and lasting improvements up to 12 weeks with auricular PENFS that correlated with brain connectivity changes, but larger randomized sham-controlled evidence is still needed.
Where this research is happening
Decatur, UNITED STATES
- VETERANS HEALTH ADMINISTRATION — Decatur, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: WOODBURY, ANNA — VETERANS HEALTH ADMINISTRATION
- Study coordinator: WOODBURY, ANNA
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.