CompletedNot Applicable

Effect of Auricular Vagal Nerve Electrical Stimulation on Post-Treatment Lyme Disease Syndrome

15 participantsStarted 2022-05-31

Plain-language summary

This study is to assess if respiratory-gated auricular vagal nerve stimulation (RAVANS) can improve symptoms of post-treatment Lyme disease syndrome

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adults of all genders ≥ 18 years
✓. History of Lyme disease treated with antibiotics, and current PTLDS diagnosed by a physician
✓. Evidence of past B. burgdorferi infection based on positive results from both enzyme immunoassay and Western blot testing.
✓. Ability to provide informed consent,
✓. willing to maintain current PTLDS treatment regimen during participation in the study (if on long-term antibiotics or supplements for PTLDS management).

✕. History of other neurological disorder that in the judgement of the investigator could interfere with the treatment or the interpretation of the results (e.g., epilepsy, history of stroke, tumor, brain tissue damaging pathologies etc.).
✕. Current psychotic disorder (e.g., schizophrenia).
✕. Current acute illness or infection (e.g. cold or flu).
✕. Current or past history of psychiatric illness; PTSD, depression and anxiety are exclusion criteria only if the conditions are so severe as to have required hospitalization in the past 5 years.
✕. History of recurrent vaso-vagal syncope
✕. Bradycardia defined as resting heart rate \<50bpm
✕. Implanted electronic device (e.g., pacemaker, neurostimulator)
✕. Use of immunosuppressive medication such as prednisone, TNF medications within 2 weeks of the visit or anticipated use during the study.

Horowitz Lyme-Multiple Systemic Infectious Disease Syndrome Questionnaire

Timeframe: Before treatment (baseline) and Post treatment ( at the end of 2-week treatment)

NCT IDNCT04938687

SponsorSpaulding Rehabilitation Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-11

Results submitted2025-08-09

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adults of all genders ≥ 18 years
✓. History of Lyme disease treated with antibiotics, and current PTLDS diagnosed by a physician
✓. Evidence of past B. burgdorferi infection based on positive results from both enzyme immunoassay and Western blot testing.
✓. Ability to provide informed consent,
✓. willing to maintain current PTLDS treatment regimen during participation in the study (if on long-term antibiotics or supplements for PTLDS management).

✕. History of other neurological disorder that in the judgement of the investigator could interfere with the treatment or the interpretation of the results (e.g., epilepsy, history of stroke, tumor, brain tissue damaging pathologies etc.).
✕. Current psychotic disorder (e.g., schizophrenia).
✕. Current acute illness or infection (e.g. cold or flu).
✕. Current or past history of psychiatric illness; PTSD, depression and anxiety are exclusion criteria only if the conditions are so severe as to have required hospitalization in the past 5 years.
✕. History of recurrent vaso-vagal syncope
✕. Bradycardia defined as resting heart rate \<50bpm
✕. Implanted electronic device (e.g., pacemaker, neurostimulator)
✕. Use of immunosuppressive medication such as prednisone, TNF medications within 2 weeks of the visit or anticipated use during the study.