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New treatment option for Post-treatment Lyme Disease Syndrome
Official title Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
ClinicalTrials.gov ID: NCT06655844
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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)
See the full eligibility 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...
- 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 positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme...
- Ages 18+
- Fluent in English
- Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.