Clinical trial NCT06655844: Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Official title: Extended Home-use Trial of a Novel Device to Reduce Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-treatment Lyme Disease Syndrome
Chronic Pain
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Sana Health, Inc.
First posted: 2024-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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)

Primary outcomes:
measure: Neuropathic Pain Symptom Inventory
timeFrame: Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: General Anxiety Disorder 7-item questionnaire (GAD-7)
timeFrame: Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Post-assessment (Week 10); Follow up (Week 14)
measure: Visual analogue scale (VAS)- Pain
timeFrame: VAS-Pain: before and after each time they use the device up to 14 weeks
measure: Visual analogue scale (VAS)- Sleep
timeFrame: VAS-Sleep: once/day up to 14 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: