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Veterans' fibromyalgia pain targeted by Drug-Free brain zaps

NCT ID NCT04115033

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a non-invasive, FDA-approved device called cranial electrical stimulation (CES) can reduce chronic pain in veterans with fibromyalgia. Fifty veterans received either real CES or a placebo treatment for several weeks. Researchers used brain scans and pain surveys to see if CES changes pain levels and brain activity, aiming to find a safer alternative to opioids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects must be male and female Veterans age 20-60 with a diagnosis of fibromyalgia as diagnosed by a clinician, by chart review, and by the most recent American College of Rheumatology 2010 criteria for the diagnosis of fibromyalgia. * Subjects must self-report consistent, daily pain (greater than 5 on the VAS) \>90 days. * Subjects must have intact skin free of infection at the site of electrode placement. * Subjects must be willing to participate and understand the consent. * Subjects must be right-handed in order to provide consistency in brain structure and function. Exclusion Criteria: * Subjects must not be currently pregnant, since effects of fMRI and electrical current on the developing fetus are not well-known. * Subjects must not have an implanted electrical device such as a vagal stimulator, pacemaker, or spinal pain pump, which are not compatible with MRI. * Subjects must not have a history of seizures or neurologic condition that may alter the structure of the brain. * Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation. * Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site. * Subjects must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications. * Subjects must not introduce new medications or treatments for fibromyalgia symptoms during the course of the study to prevent confounding results.

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Conditions

The condition(s) this trial relates to.

fibromyalgia myofascial pain syndrome Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004, United States

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