taVNS for Persistent Symptoms From Lyme Disease

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05776251
Status
Recruiting
Apply to this trial

Conditions

  • Post-Treatment Lyme Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 8, 2023
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PTLD - active taVNS
    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.

Primary Outcome Measure

Recruitment Rate [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lyme and Tick-Borne Diseases Research CenterNew YorkNew York10032
Brian A. Fallon, MD
[email protected]
646-774-7503
Mara Kuvaldina, PhD
[email protected]
646-774-7503
Brian A. Fallon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Lyme and Tick-Borne Diseases Research Center· New York, NY

Related Studies