Actively Recruiting
taVNS for Persistent Symptoms From Lyme Disease
Led by Columbia University · Updated on 2026-05-06
24
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is one of the first studies to investigate a non-antibiotic approach to the treatment of symptoms that persist after antibiotic treatment for Lyme disease (PTLS). Transcutaneous auricular vagus nerve stimulation (taVNS) offers the potential of being an effective and non-toxic approach to reduce the burden of multisystem symptoms in patients with PTLS. This study seeks to address an important goal: to assess the safety, feasibility, and tolerability of a new non-invasive, non-pharmacologic treatment for patients with symptoms that persist despite prior antibiotic treatment for Lyme disease.
CONDITIONS
Official Title
taVNS for Persistent Symptoms From Lyme Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of definite or highly probable past Lyme disease diagnosed and treated by a health care provider more than 6 months ago
- Have one or more current symptoms attributed to Lyme disease that were present during the first 6 months after diagnosis and treatment
- Current symptoms cause clinically significant distress or impair functioning
- Previously treated with at least two courses of appropriate antibiotics for Lyme disease
- Agree not to start new medical or psychiatric treatments that might affect study outcomes during the study unless advised by primary care physician
- Current treatments that might impact study outcomes have been stable for at least 6 weeks before baseline visit
- Lives in the U.S. and owns a smartphone, tablet, or computer with Internet access
- Able to read and understand English to provide informed consent
- Able and willing to attend 3 to 5 study visits at Columbia University Irving Medical Center
- Willing to have a 12-lead electrocardiogram (EKG) done or provide a recent EKG for review
- Current moderate to severe fatigue with a score of 4 or more on the Fatigue Severity Scale
- Able to allocate time for six treatment sessions monitored during work hours (8 am to 6 pm)
You will not qualify if you...
- Current or past cardiovascular disorders including coronary artery disease, peripheral artery disease, stroke, aortic disease, or other major heart conditions
- History within the last year of unexplained fainting, vasovagal syncope, or feeling faint in medical settings or pain
- Symptomatic slow heart rate, orthostatic hypotension not correctable by fluid intake, or persistent low blood pressure
- Abnormal EKG findings considered significant by a cardiologist
- Diagnosed major central nervous system diseases such as multiple sclerosis, epilepsy, neurodegenerative diseases, ischemic stroke, Parkinson's, brain surgery history, or brain tumors
- Current psychiatric disorders impacting treatment compliance including bipolar disorder, psychosis, substance abuse
- Suicidal thoughts with plan or intent in the last 6 months or history of suicidal behavior
- Current moderate to severe depression
- Serious unstable medical illness
- Currently taking opiate-based medication or antibiotics for tick-borne illness within last 6 weeks
- Ear-related conditions such as facial or ear pain, recent ear trauma, ear damage preventing taVNS, ear infections, ear scars or inflammation, cochlear implants
- Currently or recently (within 6 months) participating in another clinical trial with an investigational drug or device
- Pregnant or planning pregnancy during the study
- Unable to connect to the Internet during treatment phase
- Active external or implanted electrical medical devices or metal implants above the neck
- History of surgery cutting the vagus nerve in the neck
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lyme and Tick-Borne Diseases Research Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
B
Brian A. Fallon, MD
CONTACT
M
Mara Kuvaldina, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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