Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

NCT06655844 | Recruiting

• 1 other identifier: STUDY-18-01103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-treatment Lyme Disease Syndrome; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Neuropathic Pain Symptom Inventory

  This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Full scale from 0-10 with higher score indicating more symptom. Change in score at Week 2, Week 10 and Week 14 as compared to Baseline.

  Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

Secondary Outcomes (6)

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• Beck Depression Inventory (BDI)

  Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• General Anxiety Disorder 7-item questionnaire (GAD-7)

  Baseline 1 (Week 0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14)

• Patient's Global Impression of Change (PGIC)

  Post-assessment (Week 10); Follow up (Week 14)

• Visual analogue scale (VAS)- Pain

  VAS-Pain: before and after each time they use the device up to 14 weeks

Study Arms (2)

Real Arm

EXPERIMENTAL

This group will experience the active device settings.

Device: Sana Pain Reliever

Sham Arm

SHAM COMPARATOR

This group will experience the sham device settings.

Device: Sham SPR

Interventions

Sana Pain Reliever DEVICE

The Sana Pain Reliever (Sana PR) by Sana Health Inc is a device comprised of one (1) main component (Mask with Earbuds) and two (2) ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears).

Real Arm

Sham SPR DEVICE

Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 15 minutes and run under the device's sham settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.

Sham Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Sana Health, Inc.: collaborator

Study Sites (1)

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Post-Lyme Disease Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Lyme Disease; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• David Putrino, PT, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Tabacof, MD

CONTACT

212-241-8454; CoreResearch@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 4, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)