NCT04938687: RavLyme

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

Completed Results posted Last updated 12 February 2026

What this trial tests

trial testing respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) in Post-Treatment Lyme Disease Syndrome in 15 participants. Completed in 25 April 2025.

Timeline

31 May 2022

Primary endpoint
11 August 2024

25 April 2025

Quick facts

Lead sponsor	Spaulding Rehabilitation Hospital
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	15
Start date	31 May 2022
Primary completion	11 August 2024
Estimated completion	25 April 2025

Drugs / interventions tested

• respiratory-gated auricular vagal afferent nerve stimulation (RAVANS)
• Sham RAVANS

Conditions studied

• Post-Treatment Lyme Disease Syndrome — all drugs for Post-Treatment Lyme Disease Syndrome →

Sponsor

Spaulding Rehabilitation Hospital

Who can join

18 and older, any sex, with Post-Treatment Lyme Disease Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Horowitz Lyme-Multiple Systemic Infectious Disease Syndrome Questionnaire Primary · Before treatment (baseline) and Post treatment ( at the end of 2-week treatment)

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

Before Treatment

Group	Value	95% CI
RAVANS	50.5	± 21.3
Sham Stimulation	44.8	± 14.1

Post Treatment

Group	Value	95% CI
RAVANS	33.8	± 17.3
Sham Stimulation	25.6	± 9.9

Sedentary Behaviors Questionnaire Secondary · Before treatment (baseline) and Post treatment (at the end of 2-week treatment)

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

Before Treatment

Group	Value	95% CI
RAVANS	55.8	± 11.5
Sham Stimulation	49.5	± 8.4

Post Treatment

Group	Value	95% CI
RAVANS	48.8	± 22.5
Sham Stimulation	52.6	± 12.4

Fatigue Symptom Inventory Secondary · Before treatment (baseline) and Post treatment (at the end of 2-week treatment)

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

Before Treatment

Group	Value	95% CI
RAVANS	89.4	± 20.6
Sham Stimulation	65.4	± 34.3

Post Treatment

Group	Value	95% CI
RAVANS	66.8	± 31.4
Sham Stimulation	44.3	± 22.9

Brief Pain Inventory-Pain 24 Hours Secondary · Before treatment (baseline) and Post treatment (at the end of 2-week treatment)

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

Before Treatment

Group	Value	95% CI
RAVANS	5.6	± 2.1
Sham Stimulation	6.4	± 2.2

Post Treatment

Group	Value	95% CI
RAVANS	4.8	± 3.3
Sham Stimulation	4.4	± 2.9

Beck Depression Inventory Secondary · Before treatment (baseline) and Post treatment (at the end of 2-week treatment)

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

Before Treatment

Group	Value	95% CI
RAVANS	42.1	± 12.9
Sham Stimulation	33.3	± 10.9

Post Treatment

Group	Value	95% CI
RAVANS	33.7	± 14.6
Sham Stimulation	28	± 4.9

Beck Anxiety Inventory Secondary · Before treatment (at baseline) and after treatment (at the end of 2-week treatment)

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

Before Treatment

Group	Value	95% CI
RAVANS	19.5	± 11.1
Sham Stimulation	13.1	± 0.8

Post Treatment

Group	Value	95% CI
RAVANS	11.5	± 9.9
Sham Stimulation	9.3	± 6.2

Pittsburgh Sleep Quality Index Secondary · Before treatment (baseline) and Post treatment (at the end of 2-week treatment)

This 9-item questionnaire assesses sleep quality and patterns of sleep. Minimum value: 0 Maximum value: 21 The higher scores mean poorer sleep quality

Before Treatment

Group	Value	95% CI
RAVANS	13.8	± 4.2
Sham Stimulation	9.0	± 4.2

Post Treatment

Group	Value	95% CI
RAVANS	9.8	± 5.7
Sham Stimulation	8.0	± 3.9

Timed Up and Go Secondary · Before treatment ( baseline) and Post treatment (at the end of 2-week treatment)

Measures the time it takes for a person to stand up from a chair, walk 3 meter, turn, walk back, and sit down again.

Before Treatment

Group	Value	95% CI
RAVANS	10.5	± 3.5
Sham Stimulation	9.3	± 2.4

Post Treatment

Group	Value	95% CI
RAVANS	9.5	± 2.8
Sham Stimulation	8.6	± 1.7

Time to Complete 4 Meters at Usual Walking Speed, Secondary · Before treatment (baseline) and Post treatment (at the end of 2-week treatment)

Measure usual walk speed

Before Treatment

Group	Value	95% CI
RAVANS	4.9	± 1.1
Sham Stimulation	4.6	± 0.6

Post Treatment

Group	Value	95% CI
RAVANS	4.2	± 0.9
Sham Stimulation	4.3	± 1.0

NIH Toolbox Cognition Battery (NIHTB-CB) Secondary · Before treatment (at baseline) and Post treatment (at the end of 2-week treatment)

The following cognitive domains are assessed: executive function (Flanker inhibitory control and attention); cognitive flexibility (Dimensional Change Card Sort); working memory (List Sorting); short-term memory (Picture Sequence), processing speed (Pattern Comparison), Picture vocabulary and Oral Reading Recognition Tests. An overall composite score that combines these outcomes (Total Cognition Composite Score) is reported here. The higher value means better cognitive function. A score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest

Before Treatment

Group	Value	95% CI
RAVANS	109.8	± 7.6
Sham Stimulation	107.2	± 4.7

Post Treatment

Group	Value	95% CI
RAVANS	118.7	± 9.2
Sham Stimulation	113.6	± 9.1

Serum Level of Inflammatory Cytokines-IL6 Secondary · Before treatment (baseline) and Post treatment (at the end of 2-week treatment)

To determine if RAVANS treatment affects the level of inflammation

Before Treatment

Group	Value	95% CI
RAVANS	1897	± 1658
Sham Stimulation	2648	± 1920

Post Treatment

Group	Value	95% CI
RAVANS	2798	± 2391
Sham Stimulation	2044	± 661

Serum Level of Inflammatory Cytokines-IL10 Secondary · Before treatment (at baseline) and after treatment (at the end of 2-week treatment)

To determine if RAVANS treatment affects the level of inflammation

Before Treatment

Group	Value	95% CI
RAVANS	668	± 293
Sham Stimulation	742	± 308

Post Treatment

Group	Value	95% CI
RAVANS	616	± 159
Sham Stimulation	713	± 217

Adverse events — posted to ClinicalTrials.gov

Time frame: within the study period-2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RAVANS

Serious: 0/8 (0%)

Deaths: 0/8

Sham Stimulation

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (3 terms — click to expand)

Reaction	System	RAVANS	Sham Stimulation
Headache	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Dizziness	General disorders	—	—

Data from ClinicalTrials.gov NCT04938687 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.