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Zapping a nerve in the ear might ease lingering lyme disease symptoms

NCT ID NCT04938687

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a device called RAVANS that delivers mild electrical pulses to a nerve in the ear, aiming to reduce symptoms of post-treatment Lyme disease syndrome (PTLDS). Fifteen adults with PTLDS received either real or sham stimulation. The main goal was to see if the treatment could lower symptom scores on a detailed questionnaire. Because this is a very small early study, the results are preliminary and need confirmation in larger trials.

What this could mean

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

Active substance
respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) device
What this could lead to
If it works, this could point toward a drug-free way to manage lingering Lyme symptoms like fatigue and pain.
What could go wrong
This is a very small pilot study with only 15 people, so results may not apply widely. The device is experimental and may not provide meaningful relief.

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.

Participants

15 people

The number who actually took part.

Started

May 2022

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Adults of all genders ≥ 18 years 2. History of Lyme disease treated with antibiotics, and current PTLDS diagnosed by a physician 3. Evidence of past B. burgdorferi infection based on positive results from both enzyme immunoassay and Western blot testing. 4. Ability to provide informed consent, 5. willing to maintain current PTLDS treatment regimen during participation in the study (if on long-term antibiotics or supplements for PTLDS management). Exclusion Criteria: 1. History of other neurological disorder that in the judgement of the investigator could interfere with the treatment or the interpretation of the results (e.g., epilepsy, history of stroke, tumor, brain tissue damaging pathologies etc.). 2. Current psychotic disorder (e.g., schizophrenia). 3. Current acute illness or infection (e.g. cold or flu). 4. Current or past history of psychiatric illness; PTSD, depression and anxiety are exclusion criteria only if the conditions are so severe as to have required hospitalization in the past 5 years. 5. History of recurrent vaso-vagal syncope 6. Bradycardia defined as resting heart rate \<50bpm 7. Implanted electronic device (e.g., pacemaker, neurostimulator) 8. Use of immunosuppressive medication such as prednisone, TNF medications within 2 weeks of the visit or anticipated use during the study. 9. Current use of anti-inflammatory steroid use. 10. Pregnancy

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Conditions

The condition(s) this trial relates to.

Post-Lyme Disease Syndrome post-treatment Lyme disease syndrome

As listed by the trial registrant

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

More trials for these conditions

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