Using the Sana Device to Reduce Chronic Pain from Lyme Disease
Official title: Extended Home-use Trial of a Novel Device to Reduce Chronic Pain
Run by Icahn School of Medicine at Mount Sinai · NCT06655844 · Data updated 2026-11-12
This study is testing if the Sana Pain Reliever device can help people with chronic pain from Lyme disease feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 4, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT06655844 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with a confirmed diagnosis of Post-treatment Lyme Disease Syndrome and chronic neuropathic pain.
✕Probably not a fit
Patients who do not have a diagnosis of Post-treatment Lyme Disease Syndrome or those with other types of chronic pain unrelated to Lyme disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of the Sana Pain Reliever device in alleviating chronic pain associated with Post-treatment Lyme Disease Syndrome. The device, which includes a mask with earbuds, emits pulsed light and sound frequencies while monitoring heart rate variability. Participants will use the device for 15 minutes at a time over a 14-week period. The trial aims to enroll 50 individuals diagnosed with Post-treatment Lyme Disease Syndrome who experience chronic pain.
Why it matters
Potential benefit: If successful, this device could provide a non-invasive method to significantly reduce chronic pain for patients suffering from Post-treatment Lyme Disease Syndrome.
How similar studies have gone: While the approach using the Sana device is novel, similar studies exploring non-invasive pain relief methods have shown promise in other contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
* Lyme arthritis: Recurrent joint swelling in one or more joints
* Dermatologic: Disseminated EM ("satellite") or Acrodermatitis atrophicans AND
* Lab test Confirmation (previous) (requires at least one of the Class 1 lab tests) (MOA: self-report \& documentation) Group 2. Probable.
* Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation
* Class 1 lab test confirmation (excluding IgM WB)
* Highly suggestive IgG WB (4 of 10 bands) OR EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR
* Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard twotiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report)
* Ages 18+
* Fluent in English
* Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)
Exclusion Criteria:
* Diagnosis of photosensitive epilepsy
* Ear or eye infection
* Vision impairments that affect perception of light in one or both eyes
* Deafness in one or both ears
* Psychiatric disorders (participants will not be excluded if they score 0-30 points on the BDI, or if participants self- report having anxiety)
Where it's running
-
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States Recruiting
Study contacts
- Principal investigator: David Putrino, PT, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Laura Tabacof, MD
- Email: CoreResearch@mountsinai.org
- Phone: 212-241-8454
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.