NCT04938687

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

Pilot, Effect of Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) on Post-Treatment Lyme Disease Syndrome

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Post-Treatment Lyme Disease Syndrome

Interventions

Type	Name	Description
DEVICE	respiratory-gated auricular vagal afferent nerve stimulation (RAVANS)	non-painful electrical stimulation of the auricle
DEVICE	Sham RAVANS	sham stimulation

Timeline

• Start date: 2022-05-31
• Primary completion: 2024-08-11
• Completion: 2025-04-25
• First posted: 2021-06-24
• Last updated: 2026-02-12
• Results posted: 2025-11-10