taVNS for Persistent Symptoms From Lyme Disease
ConditionPost-Treatment Lyme Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorColumbia University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Current or past history of cardiovascular disorder(s) (coronary artery disease, peripheral artery disease, stroke, aortic disease, or other major cardiac condition). A history within the last year of unexplained fainting spells or of vasovagal syncope or feeling faint in response to medical settings or pain. Symptomatic bradycardia, orthostatic (postural) hypotension not correctable by fluid intake (i.e., a drop of >20 mm Hg systolic, 10 mm Hg diastolic or both), or persistent hypotension (BP below 90 mmHg systolic).
Abnormal EKG findings (e.g., significant bradycardia) considered significant by a cardiologist.
A diagnosed current major central nervous system disease (e.g., multiple sclerosis (MS), epilepsy, neurodegenerative diseases, ischemic stroke, Parkinson's, traumatic brain injury with cognitive impairment, etc.) or a history of brain surgery or brain tumors.
A current psychiatric disorder that might impact treatment compliance (e.g., bipolar disorder, psychosis, substance abuse).
Trial design
Design model
Single group
Treatments tested in this trial
taVNS
DeviceIncludes 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: PTLD - active taVNSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
To assess feasibility of conducting a study of taVNS for patients with persistent symptoms after Lyme disease, recruitment will be calculated from the number of participants in the study.
Time frame
Up to 4 weeks2
Compliance Rate
To assess feasibility of taVNS for patients with persistent symptoms after Lyme disease, compliance will be measured as the number of completed sessions per participant.
Time frame
Up to 4 weeks3
Drop-out Rate
To assess tolerance to taVNS, the drop-out rate will be calculated from the number of participants who discontinue from the study.
Time frame
Up to 4 weeks4
Ratings of Treatment Satisfaction (Likert Scale)
To assess tolerance to taVNS, participants will be asked to rate their satisfaction with the treatment experience on a Likert Scale, with 1 (min) indicating "very dissatisfied" to 5 (max), indicating "very satisfied". A higher score indicates a better outcome.
Time frame
Up to 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov