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Ear stimulation may tame both fibromyalgia pain and PTSD

NCT ID NCT07718984

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This trial tests whether a wearable device that gently stimulates the vagus nerve through the ear can reduce pain and PTSD symptoms in veterans who have both conditions. Participants receive six sessions of a brief PTSD therapy along with either active or sham stimulation over four weeks. The study measures changes in pain intensity, daily activity, and stress-related heart rate patterns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transauricular vagus nerve stimulation (taVNS) via a wearable ear device, combined with brief PTSD psychotherapy (Processing Emotions in Primary Care)
What this could lead to
If it works, this could offer a drug-free, at-home option for managing both pain and PTSD symptoms in veterans.
What could go wrong
This is a mid-stage trial with 180 participants, so results may not apply to everyone. The sham device also provides some sensation, which could blur the comparison.

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

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

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

18 years and older

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: 1. Subjects must be any era Veterans reporting FM and PTSD symptoms (PTSD Checklist for DSM-5 (PCL-5) ≥ 28; FM confirmed with ACR Diagnostic Criteria and pain score at least 4/10 for 3 months \[94\] 2. Subjects must speak English 3. If subjects are taking psychotropic medication, 2-weeks on stable dose prior to enrollment and agreement to maintain current medications until after the \[4-month follow-up visit\] Exclusion Criteria: 1. Subjects must not have other primary clinical issues that would interfere with FM or PTSD treatment such as recent stroke or severe heart disease 2. Subjects must not have a level of suicide risk that requires intervention as determined by item 9 on PHQ-9 with follow-up risk assessment by study staff 3. Subjects must not have severe cognitive impairment that interferes with PE-PC (unable to retain information in acute interaction) 4. Subjects must not have unmanaged psychosis or bipolar disorder 5. Subjects must not have moderate to severe substance use disorder in the past 8 weeks 6. Subjects must not be currently receiving talk therapy for trauma-related symptoms or FM 7. Subjects must not be currently pregnant or lactating given risk of pre-term labor and interference of oxytocin with VNS effects

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Conditions

The condition(s) this trial relates to.

fibromyalgia Pain post-traumatic stress disorder

As listed by the trial registrant

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

Fibromyalgia (FM) Posttraumatic stress disorder (PTSD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004, United States

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