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Device

PTLD - active taVNS for Lyme Disease

N/A
Waitlist Available
Led By Brian A. Fallon, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Summary

This trial seeks to assess a new, non-antibiotic approach to treat symptoms of Lyme disease after antibiotic treatment. taVNS offers potential to reduce burden of symptoms without side effects.

Who is the study for?
This trial is for U.S. residents who have had Lyme disease diagnosed and treated over 6 months ago, still experience significant symptoms despite antibiotic treatment, and are willing to avoid starting new treatments during the study. They must be able to attend several study visits, handle a smartphone or computer with internet, and not have serious unstable illnesses or certain cardiovascular conditions.Check my eligibility
What is being tested?
The trial is testing taVNS—a non-invasive technique stimulating the vagus nerve through the ear—as a potential treatment for persistent symptoms after Lyme disease. Participants will undergo multiple sessions of this therapy to evaluate its safety, feasibility, and how well they can tolerate it.See study design
What are the potential side effects?
While specific side effects of taVNS are not detailed in this summary, similar non-invasive nerve stimulation methods may cause discomfort at the stimulation site, headache, dizziness or skin irritation. Serious side effects are rare but could include changes in heart rate or blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance Rate
Drop-out Rate
Ratings of Treatment Satisfaction (Likert Scale)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PTLD - active taVNSExperimental Treatment1 Intervention
Participants with Post-treatment Lyme Disease (PTLD) will start with 40 sessions (i.e., 4 weeks of Monday to Friday, twice daily treatments that last 1 hour each session) to receive transcutaneous auricular Vagus Nerve Stimulation (taVNS). If compliance is less than 70% in at least 3 of the first 4 open label treated participants, then the investigators will modify the treatment design accordingly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
taVNS
2011
Completed Phase 4
~250

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,486 Total Patients Enrolled
Brian A. Fallon, MDPrincipal InvestigatorColumbia University
~2 spots leftby Jul 2025
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