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

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals who continue to experience symptoms after Lyme disease treatment. The treatment uses a device to stimulate a nerve in the ear, potentially reducing ongoing symptoms without drugs. Known as Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), this method will be evaluated for safety and tolerability. Individuals who have had Lyme disease, still experience bothersome symptoms, and have tried antibiotics twice might be suitable candidates. Participants must be able to travel to NYC for visits and have reliable internet access. As an unphased trial, this study offers a chance to contribute to groundbreaking research that could lead to new, non-drug treatments for Lyme disease symptoms.

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.

What prior data suggests that this technique is safe for treating symptoms of Lyme disease?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive treatment that people generally tolerate well. Studies suggest that taVNS does not cause significant side effects and is considered non-toxic, meaning it doesn't harm the body like some medications might.

While researchers continue to study taVNS for treating symptoms after Lyme disease, it has shown promise in other conditions without major safety concerns. The current study phase, labeled "Not Applicable," typically indicates an early stage focused on assessing safety and feasibility. This often suggests that earlier tests have demonstrated sufficient safety to proceed to more detailed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for Post-treatment Lyme Disease (PTLD), which often involve antibiotics and symptom management, transcutaneous auricular Vagus Nerve Stimulation (taVNS) offers a unique approach. Researchers are excited about taVNS because it targets the vagus nerve through a non-invasive, wearable device, potentially reducing inflammation and improving autonomic function. This method could provide relief without the side effects associated with long-term antibiotic use, offering a promising alternative for those who don't respond to standard treatments.

What evidence suggests that taVNS is effective for Lyme disease?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS), which participants in this trial will receive, might help with symptoms lingering after Lyme disease treatment. The vagus nerve, a crucial part of the nervous system, can reduce swelling and influence how the brain manages pain and mood. Studies have found that stimulating this nerve might improve ongoing symptoms like tiredness and pain. Early results suggest that taVNS is a safe and gentle method that could ease these lasting symptoms. Although more research is needed, taVNS offers hope for those who haven't found relief from antibiotics alone. ^{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. trialx.com trialx.com/clinical-trials/listings/260564/tavns-for-persistent-symptoms-from-lyme-disease/

taVNS for Persistent Symptoms From Lyme Disease 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05776251

taVNS for Persistent Symptoms From Lyme Disease Vagus nerve stimulation (VNS) may be a treatment with considerable impact for patients with post-treatment Lyme disease. The vagus nerve (the 10th and longest ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10525519/

Neuropsychiatric Lyme Disease and Vagus Nerve Stimulation Vagus nerve stimulation (VNS) may be a treatment with considerable promise for patients with post-treatment Lyme disease, as research over the ...

4. recruit.cumc.columbia.edu recruit.cumc.columbia.edu/studyinfopage/2503

Vagus Nerve Stimulation: A New Treatment Study ... - RecruitMe This new research study aims to test a new form of treatment for people with persistent symptoms despite antibiotic treatment for Lyme disease.

5. withpower.com withpower.com/trial/phase-lyme-disease-3-2023-e81da

taVNS for Lyme Disease This N/A medical study run by Columbia University is evaluating whether taVNS will have tolerable side effects & efficacy for patients with Fatigue, Lyme ...