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New treatment option for Post-Treatment Lyme Disease
Official title taVNS for Persistent Symptoms From Lyme Disease
ClinicalTrials.gov ID: NCT05776251
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
You likely can't join if
- Current or past history of cardiovascular disorder(s) (coronary artery disease, peripheral artery disease, stroke, aortic disease, or other major...
- 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...
- 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 (T-score of 65 or higher on the PROMIS-Emotional Distress-Depression SF) at screening.
See the full eligibility criteria
Who can join
- 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...
- 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).
What rules you out
- 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...
- 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...
- 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 (T-score of 65 or higher on the PROMIS-Emotional Distress-Depression SF) 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.