Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

Mount Sinai Health System

Status: Enrolling

Conditions: Chronic Pain; Post-treatment Lyme Disease Syndrome

Treatments: Device: Sana Pain Reliever; Device: Sham SPR

Study type: Interventional

Funder types: Other

Identifiers

NCT06655844

STUDY-18-01103

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Real Arm

Experimental group

Description:

This group will experience the active device settings.

Treatment:

Device: Sana Pain Reliever

Sham Arm

Sham Comparator group

Description:

This group will experience the sham device settings.

Treatment:

Device: Sham SPR