Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

Inclusion Criteria26

• 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)