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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 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.

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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.

Conditions Studied

Fibromyalgia

Interventions

  • DEVICE Percutaneous electrical nerve field stimulation

Study Locations (1)

Georgia

  • Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2024-11-01
Est. Completion 2028-11-01
Phase NA

Sponsor

VA Office of Research and Development

1,668 total trials

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What the Registry Record Tells You About NCT06415591

The ClinicalTrials.gov registry entry for NCT06415591 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 176-participant average among 76 other Fibromyalgia trials with a reported enrollment target (36% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.