Could a tiny ear zap ease Long-Term lyme symptoms?
NCT ID NCT05776251
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a small, non-invasive device that gently stimulates a nerve in the ear (taVNS) to see if it is safe and tolerable for people with persistent symptoms after Lyme disease treatment. The trial will enroll 24 adults who still have symptoms like fatigue or pain months after antibiotics. The main goal is to check if people will use the device and if it causes any side effects, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous auricular vagus nerve stimulation (taVNS) device
- What this could lead to
- If this approach is safe and tolerable, it could point toward a non-drug way to reduce lingering symptoms after Lyme disease treatment.
- What could go wrong
- This is a very small, early feasibility study with only 24 participants. It is not designed to prove effectiveness, and the device may not provide meaningful symptom 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.
- Phase
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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
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * History of either Definite or Highly Probable Past Lyme disease diagnosed and treated by a health care provider more than 6 months previously. * Have one or more current symptoms attributed to Lyme disease that were also present during the initial 6-month period after diagnosis and antibiotic treatment of Lyme disease. * Individuals reporting that current symptoms cause clinically significant distress or impairment in functioning. * Previously treated for Lyme disease with at least two courses of antibiotics considered appropriate for Lyme disease. * Individuals who agree to not start a new medical or psychiatric treatment (that might impact study outcomes) for their chronic symptoms during the course of this study (unless deemed necessary by their primary care physician (PCP)). * Individuals whose current treatment (that might impact study outcomes) has been stable for at least 6 weeks prior to baseline visit. * Lives in the U.S. and owns a smartphone, tablet or computer with Internet access. * Able to read and understand English to be able to provide informed consent. * Able and willing to come to Columbia University Irving Medical Center in NYC for 3-5 study visits. * Willingness to have a 12-lead electrocardiogram (EKG) when evaluated on site and, if an EKG was conducted in the past year, willingness to try to obtain that EKG for us to review. * Current moderate to severe fatigue. At least moderate intensity at study screening (a score of 4 or more on the Fatigue Severity Scale (FSS)). * Ability to allocate sufficient time for the treatment sessions, including 6 sessions that will be monitored during work hours (8 am to 6 pm). Exclusion Criteria: * Current or past history of cardiovascular disorder(s) (coronary artery disease, peripheral artery disease, stroke, aortic disease, or other major cardiac condition). A history within the last year of unexplained fainting spells or of vasovagal syncope or feeling faint in response to medical settings or pain. Symptomatic bradycardia, orthostatic (postural) hypotension not correctable by fluid intake (i.e., a drop of \>20 mm Hg systolic, 10 mm Hg diastolic or both), or persistent hypotension (BP below 90 mmHg systolic). * Abnormal EKG findings (e.g., significant bradycardia) considered significant by a cardiologist. * A diagnosed current major central nervous system disease (e.g., multiple sclerosis (MS), epilepsy, neurodegenerative diseases, ischemic stroke, Parkinson's, traumatic brain injury with cognitive impairment, etc.) or a history of brain surgery or brain tumors. * A current psychiatric disorder that might impact treatment compliance (e.g., bipolar disorder, psychosis, substance abuse). * Suicidal ideation with method, plan or intent in the last 6 months or a lifetime history of suicidal behavior. * Current moderate-severe or severe depression (T-score of 65 or higher on the PROMIS-Emotional Distress-Depression SF) at screening. * Current serious unstable medical illness. * Currently taking opiate-based medication or have taken antibiotics in the last 6 weeks for tick-borne illness. * Ear-related: a) facial or ear pain; b) recent ear trauma; c) damage to left or right ear or anatomy that does not allow taVNS; d) ear infection (otitis media or externa); e) scar or inflammation on ear; f) Cochlear implants. * Currently or recently (within 6 months) in a clinical trial of an investigational medicinal product or another medical device. * Females who are pregnant or planning to become pregnant during the course of this study. * Unable to connect to the Internet during treatment phase. * Individuals with an active external or implanted electrical medical device (e.g., cardiac pacemaker, hearing aid implant) or any metal implant above the level of the neck. * Individuals who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Lyme and Tick-Borne Diseases Research Center
RECRUITINGNew York, New York, 10032, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Lyme disease in pregnancy: new study tracks baby brain development
- Zapping brain fog: new study tests tDCS for Lyme-Related memory issues
- Can a common antibiotic ease lingering lyme fatigue?
- Could a 'Pulse' of antibiotics ease Long-Term lyme symptoms?