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NCT06415591 · ClinicalTrials.gov registry record · NA
Auricular Neuromodulation in Veterans With Fibromyalgia
A NA study of Fibromyalgia, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT06415591: Recruiting NA study of Fibromyalgia, sponsored by VA Office of Research and Development.
NCT06415591 is a NA study of Fibromyalgia that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 240 participants, above the 176-participant average among 76 other Fibromyalgia trials with a reported enrollment target (36% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06415591, a NA study of Fibromyalgia, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The investigators will assess whether pain and functional improvements occur with the application of PENFS. Clinical pain, as measured by the Defense Veterans Pain Rating Scale (DVPRS), will be our primary outcome. This measure is rated on a scale of 0 to 10, with 0 being "no pain" and 10 being "as bad as it could be, nothing else matters". Assessments will be administered at baseline, immediately pre- and post-treatment (the device is replaced every 5 days for a total of 4 device applications),
Conditions Studied
Interventions
- DEVICE Percutaneous electrical nerve field stimulation
Study Locations (1)
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2028-11-01 |
| Phase | NA |
What NCT06415591 shows while recruiting
NCT06415591 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 176-participant average among 76 other Fibromyalgia trials with a reported enrollment target (36% higher).
The record links to 1 condition, with Fibromyalgia appearing as the primary indexed condition, and to 1 intervention - of which Percutaneous electrical nerve field stimulation is the first listed.
NCT06415591 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06415591 about?
NCT06415591 is a clinical study titled "Auricular Neuromodulation in Veterans With Fibromyalgia". 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. PENF...
What is the current status of trial NCT06415591?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2024-11-01. Estimated completion is 2028-11-01.
What conditions does trial NCT06415591 study?
This clinical trial studies the following conditions: Fibromyalgia.
What interventions are being tested in trial NCT06415591?
The interventions under investigation include: Percutaneous electrical nerve field stimulation (DEVICE).
Who is sponsoring clinical trial NCT06415591?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06415591 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06415591's enrollment target sits among peer trials
240 18th of 76 higher than 59 of 76 other Fibromyalgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fibromyalgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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