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

Mass General Brigham

Status: Completed

Conditions: Post-Treatment Lyme Disease Syndrome

Treatments: Device: Sham RAVANS; Device: respiratory-gated auricular vagal afferent nerve stimulation (RAVANS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04938687

2021P000566

Details and patient eligibility

About

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

Full description

Lyme disease is caused by the tick-borne spirochete bacteria Borrelia burgdoferi and is the most common vector borne illness in the US. A subset of individuals with confirmed Lyme disease go on to experience persistent fatigue, pain, and/or neurocognitive difficulties after treatment that are of sufficient severity to impact quality of life and physical functioning. This chronic condition has since been termed post-treatment Lyme disease syndrome (PTLDS). The cause of PTLDS is not known and currently there are no recommended treatments.

We have hypothesized that some cases of PTLDS may be caused by an infection or inflammatory process on or near the neuroimmune vagus nerve, which communicates the detection of peripheral inflammation to the central nervous system and triggers the sickness response circuitry.

Increasing evidence shows that transcutaneous auricular nerve stimulation (taVNS) can significantly reduce multiple symptoms of stress disorder including depression, cognitive impairment, psychomotor retardation, sleep disturbance. Respiratory-gated auricular vagal afferent nerve stimulation(RAVANS), a type of taVNS, which synchronizes stimulation to the respiratory cycle, modulate vagal systems and optimize stimulations and has been shown beneficial effect in pain management.

In this study, we will conduct a randomized, double blinded, sham-controlled pilot study to explore the effect of RAVANS on the symptoms in individuals diagnosed with PTLDS using psychometric measurement, function and cognitive test, and serum biomarkers.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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.).
2. Current psychotic disorder (e.g., schizophrenia).
3. Current acute illness or infection (e.g. cold or flu).
4. 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.
5. History of recurrent vaso-vagal syncope
6. Bradycardia defined as resting heart rate <50bpm
7. Implanted electronic device (e.g., pacemaker, neurostimulator)
8. Use of immunosuppressive medication such as prednisone, TNF medications within 2 weeks of the visit or anticipated use during the study.
9. Current use of anti-inflammatory steroid use.
10. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

RAVANS

Experimental group

Description:

active RAVANS, 20 minutes each treatment, 3 times per week for 2 weeks

Treatment:

Device: respiratory-gated auricular vagal afferent nerve stimulation (RAVANS)

Sham stimulation

Sham Comparator group

Description:

Sham-stimulation, 20 minutes each treatment, 3 times per week for 2 weeks

Treatment:

Device: Sham RAVANS