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 range
18 Years – 65 Years
Sex
ALL
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be focused on figuring out whether the study design itself works — things like how many people sign up and how many drop out — rather than measuring whether the treatment actually reduces my Lyme symptoms. Does that mean it's too early to know if taVNS will genuinely help me, and should that affect whether I consider enrolling?
2The trial is measuring treatment satisfaction and adverse events, but not a specific symptom outcome like fatigue or pain scores as the primary goal. What would my doctor expect me to personally get out of participating, beyond contributing to research?
3Transcutaneous auricular vagus nerve stimulation involves stimulating a nerve near the ear — can my doctor explain what that actually involves day-to-day, how often I'd need to do it, and whether those demands are realistic given how I'm currently feeling with my post-treatment Lyme symptoms?
4Since this is listed as Phase NA, which often applies to feasibility or device studies, what does my doctor think is currently the standard of care for persistent Lyme symptoms, and is it worth trying those options before or alongside considering this trial?
5The trial is actively recruiting right now — are there eligibility requirements my doctor thinks might include or exclude me, and if I did enroll, what happens to my regular care during the study period?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.