taVNS for Lyme Disease
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify that you must stop taking your current medications, but your treatment should be stable for at least 6 weeks before starting the study. You also cannot start any new treatments during the study unless necessary and approved by your primary care doctor.
How is the treatment taVNS different from other treatments for Lyme disease?
taVNS (Transcutaneous Auricular Vagus Nerve Stimulation) is unique because it involves stimulating the vagus nerve through the skin of the ear, which may help modulate the body's response to inflammation, unlike traditional treatments that typically involve antibiotics to directly target the bacterial infection.12345
What is the purpose of this trial?
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.
Research Team
Brian A. Fallon, MD
Principal Investigator
Columbia University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transcutaneous auricular Vagus Nerve Stimulation (taVNS) for 4 weeks, with sessions occurring twice daily from Monday to Friday
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- taVNS
taVNS is already approved in United States, European Union for the following indications:
- Epilepsy
- Depression
- Obesity
- Epilepsy
- Depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor