taVNS for Persistent Symptoms From Lyme Disease

NCT05776251 | Recruiting FDA Device

• 1 other identifier: AAAV3947
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Treatment Lyme Disease

Keywords

Lyme Disease; Vagus Nerve Stimulation; taVNS; Fatigue; Post-Treatment Lyme Disease

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  To assess feasibility of conducting a study of taVNS for patients with persistent symptoms after Lyme disease, recruitment will be calculated from the number of participants in the study.

  Up to 4 weeks

• Compliance Rate

  To assess feasibility of taVNS for patients with persistent symptoms after Lyme disease, compliance will be measured as the number of completed sessions per participant.

  Up to 4 weeks

• Drop-out Rate

  To assess tolerance to taVNS, the drop-out rate will be calculated from the number of participants who discontinue from the study.

  Up to 4 weeks

• Ratings of Treatment Satisfaction (Likert Scale)

  To assess tolerance to taVNS, participants will be asked to rate their satisfaction with the treatment experience on a Likert Scale, with 1 (min) indicating "very dissatisfied" to 5 (max), indicating "very satisfied". A higher score indicates a better outcome.

  Up to 4 weeks

• Total Number of Treatment Emergent Adverse Events

  To assess safety of taVNS, the total number of treatment emergent adverse events will be assessed using the Systematic Assessment for Treatment Emergent Effects (SAFTEE) tool.

  Up to 4 weeks

Study Arms (1)

PTLD - active taVNS

EXPERIMENTAL

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 the open label treated participants, then the investigators will modify the treatment design accordingly.

Device: taVNS

Interventions

taVNS DEVICE

Includes the use of Soterix Medical Device, which consists of a handheld "smart-phone" size device. There are two electrodes (designed for studies in infants) with small patches that the participant places on the external ear (the cymbals conchae and the tragus). The stimulation intensity is personalized for each participant based on perceptual threshold.

PTLD - active taVNS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of either Definite or Highly Probable Past Lyme disease diagnosed and treated by a health care provider more than 6 months previously.
• Have one or more current symptoms attributed to Lyme disease that were also present during the initial 6-month period after diagnosis and antibiotic treatment of Lyme disease.
• Individuals reporting that current symptoms cause clinically significant distress or impairment in functioning.
• Previously treated for Lyme disease with at least two courses of antibiotics considered appropriate for Lyme disease.
• Individuals who agree to not start a new medical or psychiatric treatment (that might impact study outcomes) for their chronic symptoms during the course of this study (unless deemed necessary by their primary care physician (PCP)).
• Individuals whose current treatment (that might impact study outcomes) has been stable for at least 6 weeks prior to baseline visit.
• Lives in the U.S. and owns a smartphone, tablet or computer with Internet access.
• Able to read and understand English to be able to provide informed consent.
• Able and willing to come to Columbia University Irving Medical Center in NYC for 3-5 study visits.
• Willingness to have a 12-lead electrocardiogram (EKG) when evaluated on site and, if an EKG was conducted in the past year, willingness to try to obtain that EKG for us to review.
• Current moderate to severe fatigue. At least moderate intensity at study screening (a score of 4 or more on the Fatigue Severity Scale (FSS)).
• Ability to allocate sufficient time for the treatment sessions, including 6 sessions that will be monitored during work hours (8 am to 6 pm).

You may not qualify if:

• Current or past history of cardiovascular disorder(s) (coronary artery disease, peripheral artery disease, stroke, aortic disease, or other major cardiac condition). A history within the last year of unexplained fainting spells or of vasovagal syncope or feeling faint in response to medical settings or pain. Symptomatic bradycardia, orthostatic (postural) hypotension not correctable by fluid intake (i.e., a drop of \>20 mm Hg systolic, 10 mm Hg diastolic or both), or persistent hypotension (BP below 90 mmHg systolic).
• Abnormal EKG findings (e.g., significant bradycardia) considered significant by a cardiologist.
• A diagnosed current major central nervous system disease (e.g., multiple sclerosis (MS), epilepsy, neurodegenerative diseases, ischemic stroke, Parkinson's, traumatic brain injury with cognitive impairment, etc.) or a history of brain surgery or brain tumors.
• A current psychiatric disorder that might impact treatment compliance (e.g., bipolar disorder, psychosis, substance abuse).
• Suicidal ideation with method, plan or intent in the last 6 months or a lifetime history of suicidal behavior.
• Current moderate-severe or severe depression (T-score of 65 or higher on the PROMIS-Emotional Distress-Depression SF) at screening.
• Current serious unstable medical illness.
• Currently taking opiate-based medication or have taken antibiotics in the last 6 weeks for tick-borne illness.
• Ear-related: a) facial or ear pain; b) recent ear trauma; c) damage to left or right ear or anatomy that does not allow taVNS; d) ear infection (otitis media or externa); e) scar or inflammation on ear; f) Cochlear implants.
• Currently or recently (within 6 months) in a clinical trial of an investigational medicinal product or another medical device.
• Females who are pregnant or planning to become pregnant during the course of this study.
• Unable to connect to the Internet during treatment phase.
• Individuals with an active external or implanted electrical medical device (e.g., cardiac pacemaker, hearing aid implant) or any metal implant above the level of the neck.
• Individuals who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Lyme and Tick-Borne Diseases Research Center

New York, New York, 10032, United States

RECRUITING

Related Links

• Homepage for Columbia University's Lyme and Tick-Borne Diseases Research Center
• Homepage for the Lyme Clinical Trials Network
• First Step webpage for eligibility assessment for taVNS Study

MeSH Terms

Conditions

Post-Lyme Disease Syndrome; Lyme Disease; Fatigue

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Brian A. Fallon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian A. Fallon, MD

CONTACT

646-774-7503; baf1@cumc.columbia.edu

Mara Kuvaldina, PhD

CONTACT

646-774-7503; mk4480@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: May 8, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)