Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Persistent Symptoms From Lyme Disease: a Feasibility, Tolerability, and Safety Study
Columbia University
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.
Description
Musculoskeletal pain, fatigue, and cognitive and mood problems are common persistent disabling symptoms among individuals with post-treatment Lyme Disease. Each year in the United States, approximately 476,000 individuals are newly diagnosed with Lyme disease and 10-20% of these go on to have persistent or relapsing symptoms that are not responding to the current best antibiotic therapies. Individuals with persistent infection are likely to respond best to additional antibiotic therapy. Individuals with post- infectious causes require other approaches - such as ones that impact ongoing inflam…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 agre…
Interventions
- DevicetaVNS
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.
Location
- Lyme and Tick-Borne Diseases Research CenterNew York, New York