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Recruiting NCT05776251

taVNS for Persistent Symptoms From Lyme Disease

Trial Parameters

Condition Post-Treatment Lyme Disease
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-05-08
Completion 2026-06
Interventions
taVNS

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.

Eligibility Criteria

Inclusion Criteria: * 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

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