taVNS for Persistent Symptoms From Lyme Disease

This study is looking at a new way to help people with persistent symptoms after being treated for Lyme disease (Post-Treatment Lyme Disease or PTLS). It's testing a device called transcutaneous auricular vagus nerve stimulation (taVNS). This device uses small patches placed on your ear to stimulate a nerve called the vagus nerve, which may help with pain, fatigue, and thinking problems often seen in PTLS. This is one of the first studies to explore a non-antibiotic approach for these symptoms. The study aims to see if taVNS is safe, easy to use, and well-tolerated by participants. To join, you need to be between 18 and 65 years old and have a history of Lyme disease diagnosed more than 6 months ago, with symptoms that started during the initial 6 months after diagnosis and treatment and are still present. The study will measure how many people join, how consistently they use the device, and how many people drop out.

Study design: This is an interventional study with a planned enrollment of 24 participants. The phase of the study is not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The study measures recruitment rate, compliance rate, and drop-out rate for up to 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

taVNS for Persistent Symptoms From Lyme Disease

Recruiting

NAAges 18–65InterventionalTreatment

Columbia University

~24 participants

Updated 2026-05-06 on ClinicalTrials.gov

What's tested:taVNS

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Recruitment Rate

Measured over Up to 4 weeks

+4 more outcomes measured

Conditions

Post-Treatment Lyme Disease

NCT05776251

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Lyme and Tick-Borne Diseases Research Center
New York, New Yorkstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Brian A. Fallon, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Brian A. Fallon, MD

[email protected]

646-774-7503

Email the study team

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Eligibility criteria

Inclusion

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

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).

What this trial measures

Recruitment RateUp to 4 weeks
To assess feasibility of conducting a study of taVNS for patients with persistent symptoms after Lyme disease, recruitment will be calculated from the number of participants in the study.
Compliance RateUp to 4 weeks
To assess feasibility of taVNS for patients with persistent symptoms after Lyme disease, compliance will be measured as the number of completed sessions per participant.
Drop-out RateUp to 4 weeks
To assess tolerance to taVNS, the drop-out rate will be calculated from the number of participants who discontinue from the study.
Ratings of Treatment Satisfaction (Likert Scale)Up to 4 weeks
To assess tolerance to taVNS, participants will be asked to rate their satisfaction with the treatment experience on a Likert Scale, with 1 (min) indicating "very dissatisfied" to 5 (max), indicating "very satisfied". A higher score indicates a better outcome.
Total Number of Treatment Emergent Adverse EventsUp to 4 weeks
To assess safety of taVNS, the total number of treatment emergent adverse events will be assessed using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) tool.

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