RecruitingNot Applicable

Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

United States20 participantsStarted 2024-10-04

Plain-language summary

This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain. The Sana PR is a device comprised of one main component (Mask with Earbuds) and two ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies throughout a specific firmware algorithm. Through the earbuds, the device also plays different tones in conjunction with the pulses. The device has a skin contacting Heart Rate Variability (HRV) sensor built into the forehead area that measures HRV throughout the use of the device. The system runs for 15 min at a time and is not FDA approved. The trial will last a total of 14 weeks. 50 participants who have a diagnosis of Post-treatment Lyme Disease and experience chronic pain are expected to take part in this study at Mount Sinai.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed clinical diagnosis of neuropathic pain AND * Confirmed clinical diagnosis of Post-treatment Lyme disease syndrome * Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria: * Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition * Erythema Migrans * History of possible exposure to a high incidence county or state (or an adjacent area) * Erythema migrans rash * EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine) * EM 1A: MOA self-report \& medical record documentation of rash \> 5 cm * EM 1B: MOA: self-report and medical record documentation of EM rash but not size * EM 1C: MOA: self-report \& rash misdiagnosed in medical record as cellulitis/spider bite * EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR Disseminated "objective" manifestation with lab test confirmation of Bb infection * Clinical history includes at least one of the following symptoms/signs, which are not better accounted for by another cause (MOA: medical records and/or self-report). * Neurologic: Lymphocytic Meningitis; Encephalitis; Encephalomyelitis, Cranial Neuritis (especially facial palsy); Radiculoneuropathy; * Other Neurologic Signs (with objective measures): Encephalopathy, Polyneuropathy * Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neuropathic Pain Symptom Inventory

Timeframe: Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

Trial details

NCT IDNCT06655844

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Laura Tabacof, MD

212-241-8454 CoreResearch@mountsinai.org

View on ClinicalTrials.gov More Post-treatment Lyme Disease Syndrome trials