RECRUITING

taVNS for Persistent Symptoms From Lyme Disease

Conditions

Post-Treatment Lyme Disease Lyme Disease Vagus Nerve Stimulation taVNS Fatigue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Persistent Symptoms From Lyme Disease: a Feasibility, Tolerability, and Safety Study

Quick Facts

Study Start:2023-05-08

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05776251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 on the Fatigue Severity Scale (FSS)). * Ability to allocate sufficient time for the treatment sessions, including 6 sessions that will be monitored during work hours (8 am to 6 pm).	* 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). * Suicidal ideation with method, plan or intent in the last 6 months or a lifetime history of suicidal behavior. * Current moderate-severe or severe depression (score of 15 and higher) on the Patient Health Questionnaire-8 (PHQ-8) at screening. * Current serious unstable medical illness. * Currently taking opiate-based medication or have taken antibiotics in the last 6 weeks for tick-borne illness. * Ear-related: a) facial or ear pain; b) recent ear trauma; c) damage to left or right ear or anatomy that does not allow taVNS; d) ear infection (otitis media or externa); e) scar or inflammation on ear; f) Cochlear implants. * Currently or recently (within 6 months) in a clinical trial of an investigational medicinal product or another medical device. * Females who are pregnant or planning to become pregnant during the course of this study. * Unable to connect to the Internet during treatment phase. * Individuals with an active external or implanted electrical medical device (e.g., cardiac pacemaker, hearing aid implant) or any metal implant above the level of the neck. * Individuals who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).

Inclusion Criteria

Exclusion 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 on the Fatigue Severity Scale (FSS)).
* Ability to allocate sufficient time for the treatment sessions, including 6 sessions that will be monitored during work hours (8 am to 6 pm).

* 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).
* Suicidal ideation with method, plan or intent in the last 6 months or a lifetime history of suicidal behavior.
* Current moderate-severe or severe depression (score of 15 and higher) on the Patient Health Questionnaire-8 (PHQ-8) at screening.
* Current serious unstable medical illness.
* Currently taking opiate-based medication or have taken antibiotics in the last 6 weeks for tick-borne illness.
* Ear-related: a) facial or ear pain; b) recent ear trauma; c) damage to left or right ear or anatomy that does not allow taVNS; d) ear infection (otitis media or externa); e) scar or inflammation on ear; f) Cochlear implants.
* Currently or recently (within 6 months) in a clinical trial of an investigational medicinal product or another medical device.
* Females who are pregnant or planning to become pregnant during the course of this study.
* Unable to connect to the Internet during treatment phase.
* Individuals with an active external or implanted electrical medical device (e.g., cardiac pacemaker, hearing aid implant) or any metal implant above the level of the neck.
* Individuals who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).

Contacts and Locations

Study Contact

Brian A. Fallon, MD

CONTACT

646-774-7503

baf1@columbia.edu

Mara Kuvaldina, PhD

CONTACT

646-774-7503

mk4480@cumc.columbia.edu

Principal Investigator

Brian A. Fallon, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Lyme and Tick-Borne Diseases Research Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Brian A. Fallon, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-08

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-05-08

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Lyme Disease
Vagus Nerve Stimulation
taVNS
Fatigue

Additional Relevant MeSH Terms

Post-Treatment Lyme Disease