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

Spaulding Rehabilitation Hospital15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post-Treatment Lyme Disease Syndrome

Interventions

respiratory-gated auricular vagal afferent nerve stimulation (RAVANS)DEVICE

non-painful electrical stimulation of the auricle

Sham RAVANSDEVICE

sham stimulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Horowitz Lyme-Multiple Systemic Infectious Disease Syndrome Questionnaire

This 55-item questionnaire evaluates the frequency, severity, and incidence of Lyme symptoms as well as assessing one's perceived overall health. Minimum value:0 Maximum value: 114 The higher number indicates more symptoms

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

Secondary Outcomes

Sedentary Behaviors Questionnaire

This 18-item questionnaire asks about the amount of time spent engaged in sedentary behaviors on typical weekdays and weekends. Minimum:0 Maximum:162 The higher scores mean higher sedentary behaviors

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

Fatigue Symptom Inventory

This non-diagnosis-specific questionnaire measures the severity of fatigue symptoms and how much these factors interfere with the subjects' lives. Minimum value:0 Maximum value:127 The higher scores mean higher fatigue symptoms

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

Brief Pain Inventory-Pain 24 Hours

This 15-item questionnaire assesses the location, severity, and type of current pain, using analogue scales and body diagrams. Subscale-pain 24 hours describes the pain at its worst in the past 24 hours. Minimum value:0 Maximum value: 10 The higher scores means higher pain level

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

Beck Depression Inventory

This questionnaire evaluates current depressive symptoms. Minimum value: 0 Maximum value: 63 The higher scores mean higher depressive symptoms

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

Data from ClinicalTrials.gov

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