taVNS for Persistent Symptoms From Lyme Disease (NCT05776251) | Clinical Trial Compass
RecruitingNot Applicable
taVNS for Persistent Symptoms From Lyme Disease
United States24 participantsStarted 2023-05-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 …