Using the Sana Device to Reduce Chronic Pain from Lyme Disease

Extended Home-use Trial of a Novel Device to Reduce Chronic Pain

This study is testing if the Sana Pain Reliever device can help people with chronic pain from Lyme disease feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06655844 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals with a confirmed diagnosis of Post-treatment Lyme Disease Syndrome and chronic neuropathic pain.

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.

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 performed: While the approach using the Sana device is novel, similar studies exploring non-invasive pain relief methods have shown promise in other contexts.

Eligibility 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 this trial is running

New York, New York

• 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

Conditions: Post-treatment Lyme Disease Syndrome, Chronic Pain