Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

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 criteriaof 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 anadjacent 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 notsize

• EM 1C: MOA: self-report & rash misdiagnosed in medical record ascellulitis/spider bite

• EM 1D: MOA: self-report and either: photo of EM or Class 1 lab testconfirmation 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 arenot better accounted for by another cause (MOA: medical records and/or self-report).

• Neurologic: Lymphocytic Meningitis; Encephalitis; Encephalomyelitis, CranialNeuritis (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 ofpositive 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 aLyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 labtest confirmation is available (MOA: self-report) OR Viral like illness (not betterexplained by other cause) with indeterminate or + enzyme immunoassay (EIA) withpositive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset afterknown 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 orpositive EIA with positive IgM WB or positive Class 1 lab test (within 6 months ofillness onset after known exposure to a Lyme high-incidence area for standardtwotiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab testand self-report)

• Ages 18+

• Fluent in English

• Consistent medications for the last 4 weeks prior to the first baseline visit (week

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 pointson the BDI, or if participants self- report having anxiety)