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Device

PTLD - active taVNS for Lyme Disease

N/A
Recruiting
Led By Brian A. Fallon, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously treated for Lyme disease with at least two courses of antibiotics considered appropriate for Lyme disease
Current moderate to severe fatigue. At least moderate intensity at study screening (a score of 4 or more on the Fatigue Severity Scale (FSS))
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Study Summary

This trial seeks to assess a new, non-antibiotic approach to treat symptoms of Lyme disease after antibiotic treatment. taVNS offers potential to reduce burden of symptoms without side effects.

Who is the study for?
This trial is for U.S. residents who have had Lyme disease diagnosed and treated over 6 months ago, still experience significant symptoms despite antibiotic treatment, and are willing to avoid starting new treatments during the study. They must be able to attend several study visits, handle a smartphone or computer with internet, and not have serious unstable illnesses or certain cardiovascular conditions.Check my eligibility
What is being tested?
The trial is testing taVNS—a non-invasive technique stimulating the vagus nerve through the ear—as a potential treatment for persistent symptoms after Lyme disease. Participants will undergo multiple sessions of this therapy to evaluate its safety, feasibility, and how well they can tolerate it.See study design
What are the potential side effects?
While specific side effects of taVNS are not detailed in this summary, similar non-invasive nerve stimulation methods may cause discomfort at the stimulation site, headache, dizziness or skin irritation. Serious side effects are rare but could include changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated for Lyme disease with antibiotics twice.
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I am experiencing moderate to severe tiredness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance Rate
Drop-out Rate
Ratings of Treatment Satisfaction (Likert Scale)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PTLD - active taVNSExperimental Treatment1 Intervention
Participants with Post-treatment Lyme Disease (PTLD) will start with 40 sessions (i.e., 4 weeks of Monday to Friday, twice daily treatments that last 1 hour each session) to receive transcutaneous auricular Vagus Nerve Stimulation (taVNS). If compliance is less than 70% in at least 3 of the first 4 open label treated participants, then the investigators will modify the treatment design accordingly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
taVNS
2011
Completed Phase 4
~250

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,829 Total Patients Enrolled
Brian A. Fallon, MDPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially qualify for participation in this experiment?

"To be eligible for the trial, potential participants must have lyme disease syndrome post-treatment and lie within a certain age range (18-65). A total of 12 individuals are expected to take part."

Answered by AI

Are there any available slots in this experiment?

"Based on the information available from clinicaltrials.gov, it is apparent that this study has concluded its recruitment of participants; after being posted in April 1st 2023 and most recently updated on March 8th 2023. Nonetheless, there are still 9 other medical trials seeking candidates at present."

Answered by AI

Does this experiment encompass geriatric patients?

"As detailed in the inclusion criteria, individuals aged 18 to 65 are eligible for this trial. In contrast, there are four other studies that accept minors and seven different ones designed for patients over the age of sixty-five."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
District of Columbia
Tennessee
What site did they apply to?
Lyme and Tick-Borne Diseases Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1

Why did patients apply to this trial?

My daughter has been on repeated antibiotics and still continues to struggle with pain and Lyme symptoms.
PatientReceived 1 prior treatment
I am open to innovate and investigate along with the trial about new opportunities to help mills of people in the USA, and more worldwide. I know my body is still strong, but is in a constant battle with Lyme, I need to find an answer as soon as possible to ensure a quality of life that I know I deserve.
PatientReceived no prior treatments
I was diagnosed with lyme summer of 2018 and took a 3 week course of antibiotics. I was having severe joint pain, fatigue, facial palsy, and I was unable to hold a conversation without losing my train of thought almost immediately. I had no noticable symptoms for close to 3 months after the initial course before they started coming back. I was referred to rheumatology and took another course which was ineffective. Antibiotics are too rough on my stomach now so I no longer wish to take them. I have been dealing with brain fog and moderate fatigue almost daily. Prior to lyme I had no health issues. I have seen just about every specialist since with no explanation or helpful treatment.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many visits to the facility would be necessary? What is the exact protocol, what are the side effect you have detected in other patience?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
taVNS for Persistent Symptoms From Lyme Disease
Brian A. Fallon 2023. "taVNS for Persistent Symptoms From Lyme Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776251.
All > Lyme Disease
~0 spots leftby Jun 2024
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