taVNS for Lyme Disease

Overseen By Mara Kuvaldina, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Opiates, Antibiotics

Disqualifiers: Cardiovascular disorders, CNS diseases, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 40

Duration: 4 weeks

4 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

Who Is on the Research Team?

Brian A. Fallon, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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

My symptoms significantly impact my daily life.

I have been treated for Lyme disease with antibiotics twice.

I can visit the study site 3-5 times.

Exclusion Criteria

I have had surgery to cut the vagus nerve in my neck.

Currently or recently (within 6 months) in a clinical trial of an investigational medicinal product or another medical device

I am not pregnant nor planning to become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous auricular Vagus Nerve Stimulation (taVNS) for 4 weeks, with sessions occurring twice daily from Monday to Friday

4 weeks

40 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• taVNS

Trial Overview 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.

How Is the Trial Designed?

Group I: PTLD - active taVNS Experimental Treatment 1 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.

taVNS is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Depression
• Obesity

Approved in European Union as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Depression

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Respiratory modulation of cardiac vagal tone in Lyme disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Lyme carditis presenting as paroxysmal junctional tachycardia and complete atrioventricular block in an adolescent. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A case of reversible third-degree AV block due to Lyme carditis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Lyme carditis: Early occurrence and prolonged recovery. [2019]

5. Denmark pubmed.ncbi.nlm.nih.gov

[Serious arrhythmias in Borrelia infections]. [2007]