Actively Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Persistent Symptoms From Lyme Disease: a Feasibility, Tolerability, and Safety Study
Led by Columbia University · Updated on 2026-05-06
24
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a non-antibiotic treatment approach for symptoms that persist after antibiotic treatment for Lyme disease, known as post-treatment Lyme disease syndrome (PTLS). This study aims to evaluate the safety, feasibility, and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive and non-pharmacologic method, for reducing multisystem symptoms in patients with PTLS. Persistent symptoms like musculoskeletal pain, fatigue, and cognitive and mood problems affect many individuals despite antibiotic therapy, highlighting an important unmet medical need. Participants with PTLS will receive 40 sessions of taVNS over 4 weeks, with treatments administered twice daily from Monday to Friday, each lasting one hour. This treatment uses a handheld device with electrodes placed on the outer ear to stimulate the vagus nerve non-invasively. Treatment intensity is personalized based on each participant's sensory threshold. If participant compliance is below 70%, the treatment plan may be adjusted accordingly. During the study, participants will have 3 to 5 visits to Columbia University Irving Medical Center and will undergo assessments including a 12-lead electrocardiogram (EKG). Researchers will monitor recruitment, treatment compliance, participant satisfaction, drop-out rates, and any treatment-emergent adverse events over four weeks. Participants must have stable current treatments and are asked to avoid starting new treatments that might affect study outcomes. The total participation duration is approximately one month, focusing on safety and tolerability of this novel therapy.
CONDITIONS
Brief Title
taVNS for Persistent Symptoms From Lyme Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of definite or highly probable Lyme disease diagnosed and treated over 6 months ago
- Presence of one or more current symptoms attributed to Lyme disease present since initial treatment
- Symptoms cause clinically significant distress or impair functioning
- Previously treated with at least two appropriate courses of antibiotics for Lyme disease
- Agree not to start new medical or psychiatric treatments that could affect study outcomes during the study
- Current treatments 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 and provide informed consent
- Willing and able to attend 3 to 5 study visits at Columbia University Irving Medical Center
- Willing to have a 12-lead electrocardiogram (EKG) or provide recent EKG for review
- Current moderate to severe fatigue with a Fatigue Severity Scale score of 4 or higher
- Able to allocate time for treatment sessions including monitored sessions during work hours
You will not qualify if you...
- Current or past major cardiovascular disorders including coronary artery disease, stroke, peripheral artery disease, aortic disease, or major cardiac conditions
- History within the last year of unexplained fainting, vasovagal syncope, or feeling faint in medical settings
- Symptomatic bradycardia or persistent hypotension not correctable by fluid intake
- Abnormal EKG findings significant to cardiologist
- Diagnosed major central nervous system diseases such as multiple sclerosis, epilepsy, neurodegenerative disorders, or brain surgery history
- Current psychiatric disorders impacting compliance, including bipolar disorder, psychosis, substance abuse
- Suicidal ideation with plan or intent in last 6 months or lifetime history of suicidal behavior
- Current moderate-severe or severe depression by screening score
- Serious unstable medical illness
- Current use of opiate medications or recent antibiotics for tick-borne illness within 6 weeks
- Ear-related issues preventing device use including pain, trauma, infections, scarring, or cochlear implants
- Participation in another clinical trial involving investigational drugs or devices within 6 months
- Females who are pregnant or planning pregnancy during the study
- Inability to access the Internet during treatment phase
- Presence of active external or implanted electrical 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
3 to 5 visits (in-person) at Columbia University Irving Medical Center
Duration - 4 weeks
Participants receive transcutaneous auricular Vagus Nerve Stimulation (taVNS) using a handheld device applied to the external ear. Treatment consists of 40 sessions over 4 weeks, with twice daily 1-hour sessions Monday to Friday.
Daily sessions Monday to Friday, twice daily (1 hour each)
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
M
Mara Kuvaldina, PhD
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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