N/A
N=15
Effect of Auricular Vagal Nerve Electrical Stimulation on Post-Treatment Lyme Disease Syndrome
Post-Treatment Lyme Disease Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04938687 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Horowitz Lyme-Multiple Systemic Infectious Disease Syndrome Questionnaire — 50.5; 44.8; 33.8; 25.6 score on a scale — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) (Device); Sham RAVANS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Horowitz Lyme-Multiple Systemic Infectious Disease Syndrome Questionnaire |
50.5; 44.8; 33.8; 25.6 | 0.07 |
| SECONDARY Sedentary Behaviors Questionnaire |
55.8; 49.5; 48.8; 52.6 | 0.38 |
| SECONDARY Fatigue Symptom Inventory |
89.4; 65.4; 66.8; 44.3 | 0.92 |
| SECONDARY Brief Pain Inventory-Pain 24 Hours |
5.6; 6.4; 4.8; 4.4 | 0.35 |
| SECONDARY Beck Depression Inventory |
42.1; 33.3; 33.7; 28 | 0.93 |
| SECONDARY Beck Anxiety Inventory |
19.5; 13.1; 11.5; 9.3 | 0.29 |
| SECONDARY Pittsburgh Sleep Quality Index |
13.8; 9.0; 9.8; 8.0 | 0.04 sig |
| SECONDARY Timed Up and Go |
10.5; 9.3; 9.5; 8.6 | — |
| SECONDARY Time to Complete 4 Meters at Usual Walking Speed, |
4.9; 4.6; 4.2; 4.3 | — |
| SECONDARY NIH Toolbox Cognition Battery (NIHTB-CB) |
109.8; 107.2; 118.7; 113.6 | 0.42 |
| SECONDARY Serum Level of Inflammatory Cytokines-IL6 |
1897; 2648; 2798; 2044 | — |
| SECONDARY Serum Level of Inflammatory Cytokines-IL10 |
668; 742; 616; 713 | — |
| SECONDARY Serum Level of Inflammatory Cytokines-TNF Alfa |
473; 492; 485; 470 | — |
Summary
This study is to assess if respiratory-gated auricular vagal nerve stimulation (RAVANS) can improve symptoms of post-treatment Lyme disease syndrome
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
- Current use of anti-inflammatory steroid use.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT04938687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.