Sana Device for Chronic Pain from Lyme Disease

Overseen By Laura Tabacof, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Photosensitive epilepsy, Ear infection, Vision impairments, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that your medications have been consistent for the last 4 weeks before starting the trial.

What data supports the effectiveness of the Sana Device for chronic pain from Lyme disease?

The research on pulsed radiofrequency (PRF) therapy, which is similar to the Sana Device, shows it can help relieve neuropathic pain (pain from nerve damage) in conditions like neuromyelitis optica spectrum disorder. This suggests that similar treatments might also help with chronic pain from Lyme disease. ^{1 2 3 4 5}

How is the Sana Device treatment different from other treatments for chronic pain from Lyme disease?

The Sana Device is unique because it is a non-drug treatment option for chronic pain from Lyme disease, unlike traditional pharmaceutical treatments. It likely uses a novel mechanism, such as neuromodulation, to manage pain, which is different from the typical use of antibiotics or pain medications. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

David Putrino, PT, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for 50 people who have been treated for Lyme Disease but still suffer from chronic pain. Participants will use the Sana Pain Reliever device, which isn't FDA approved yet, over a period of 14 weeks at Mount Sinai.

Inclusion Criteria

Diagnosis based on meeting Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria

Fluent in English

I have been diagnosed with nerve pain.

Exclusion Criteria

Psychiatric disorders (participants will not be excluded if they score 0-30 points on the BDI, or if participants self-report having anxiety)

Vision impairments that affect perception of light in one or both eyes

I am deaf in one or both ears.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Sana Pain Reliever device to reduce chronic pain

14 weeks

Daily use of the device

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sana Pain Reliever

Trial Overview The study tests the Sana Pain Reliever's ability to reduce chronic pain in post-treatment Lyme disease sufferers. It involves wearing a mask with earbuds that deliver light pulses and tones, guided by an algorithm for 15 minutes per session.

Participant Groups

Group I: Real Arm Experimental Treatment 1 Intervention

This group will experience the active device settings.

Group II: Sham Arm Placebo Group 1 Intervention

This group will experience the sham device settings.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Sana Health, Inc.

Collaborator

Trials

2

Recruited

150+

Findings from Research

In a study of 208 immunocompetent patients over 50 with localized herpes zoster, treatment with both acyclovir and prednisone significantly accelerated healing and reduced pain compared to placebo, improving quality of life outcomes.

The combination therapy led to faster recovery times for crusting, healing, and return to normal activities, with no significant adverse events reported, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acyclovir with and without prednisone for the treatment of herpes zoster. A randomized, placebo-controlled trial. The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Whitley, RJ., Weiss, H., Gnann, JW., et al.[2023]

In a systematic review of 94 studies involving 5,317 patients, the placebo response in neuropathic pain syndromes varied significantly, with the largest response observed in HIV pain and the smallest in central pain syndromes.

The study found that the predicted mean decrease in pain intensity was highest for diabetic neuropathic pain (1.45) and lowest for central pain (0.44), indicating that the type of neuropathic pain affects how patients respond to placebo treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response changes depending on the neuropathic pain syndrome: results of a systematic review and meta-analysis. Cepeda, MS., Berlin, JA., Gao, CY., et al.[2022]

Patients who received a selective nerve root block (SNRB) within 14 days of herpes zoster onset had a significantly higher cure rate for postherpetic neuralgia (PHN) at 62.5%, compared to 25.5% for those treated later, indicating that early intervention is crucial.

The study, which followed 67 patients over a median of 5 years, found that early SNRB not only reduced the incidence of PHN but also led to a shorter duration of symptoms, with a median time to cure of 2.4 years for the acute group versus 5.0 years for the subacute group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of selective nerve root block for the long-term outcome of postherpetic neuralgia. Doo, AR., Choi, JW., Lee, JH., et al.[2022]

Scrambler Therapy is a noninvasive treatment that may offer a new option for managing postherpetic neuralgia (PHN), particularly in elderly patients who have not responded well to conventional therapies.

In a small clinical experience involving three patients with refractory PHN, Scrambler Therapy showed potential in relieving pain, suggesting it could change pain perception effectively at the brain level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experiences on the effect of scrambler therapy for patients with postherpetic neuralgia. Ko, YK., Lee, HY., Lee, WY.[2022]

A 49-year-old woman with severe neuropathic pain (NP) due to neuromyelitis optica spectrum disorder (NMOSD) experienced significant pain relief after undergoing pulsed radiofrequency (PRF) treatment on her cervical nerve root, with her pain score dropping from 7-8/10 to 2-3/10.

The pain relief achieved with PRF was maintained for three months after treatment, and there were no reported complications, suggesting that PRF could be a promising option for managing intractable NP associated with NMOSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided pulsed radiofrequency for neuromyelitis optica spectrum disorder-associated neuropathic pain: A case report. Yang, F., Lin, L., Xia, Y., et al.[2023]

A teenage girl with complex regional pain type II in her pelvic limb due to Lyme disease was successfully treated with a spinal cord stimulator, highlighting a novel approach for managing this condition.

This case is significant as it represents a rare instance of Lyme disease leading to complex pain in adolescents, with a successful treatment outcome observed over a 60-month period, which is not commonly reported in existing literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation in teenager with complex regional pain syndrome for Lyme’s disease. Case report and review of the literature]. Mejía-Terrazas, GE., López-Ruiz, VG., Infante-Cosío, G., et al.[2019]

Patients with chronic Lyme disease report experiencing real and debilitating symptoms, such as severe headaches, arthritis, and heart palpitations, which they believe are alleviated by antibiotic treatment.

The persistence of symptoms upon withdrawal of antibiotics suggests that these patients may have a genuine medical condition that is not adequately recognized or understood by the medical community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Lyme disease: it's not all in our heads. Morgenstern, RG.[2018]

A 62-year-old patient with chronic neuropathic pain from Lyme disease experienced significant pain relief after spinal cord stimulation (SCS), with Visual Analog Scale (VAS) scores dropping from 8-10 to 1-3.

This case suggests that SCS could be a promising treatment option for patients with chronic pain related to Lyme disease, especially when traditional medications and therapies have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain originating from Lyme disease. Shui, Y., Tao, W., Huang, D., et al.[2012]

A 44-year-old woman suffering from severe neuropathic pain due to Lyme disease experienced significant pain relief after being treated with concurrent thoracic and cervical spinal cord stimulation (SCS).

After 18 months of therapy, the patient reported almost complete pain relief and was able to stop using additional pain medications, suggesting that SCS may be an effective treatment option for neuropathic pain associated with Lyme disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for the Treatment of Upper and Lower Extremity Neuropathic Pain due to Lyme Disease. Mearini, M., Podetta, S., Catenacci, E., et al.[2022]

Approximately 60% of untreated Lyme disease patients develop brief episodes of oligoarticular arthritis, primarily affecting large joints like the knee, within 2 weeks to 2 years after infection.

Chronic Lyme arthritis, which can develop in about 10% of patients, has an immunogenic basis, with a significant association found between chronic arthritis and specific HLA-DR4 or -DR2 genetic markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical definitions and differential diagnosis of Lyme arthritis. Steere, AC.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acyclovir with and without prednisone for the treatment of herpes zoster. A randomized, placebo-controlled trial. The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Placebo response changes depending on the neuropathic pain syndrome: results of a systematic review and meta-analysis. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

The efficacy of selective nerve root block for the long-term outcome of postherpetic neuralgia. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical experiences on the effect of scrambler therapy for patients with postherpetic neuralgia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided pulsed radiofrequency for neuromyelitis optica spectrum disorder-associated neuropathic pain: A case report. [2023]

6. Mexico pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation in teenager with complex regional pain syndrome for Lyme’s disease. Case report and review of the literature]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Chronic Lyme disease: it's not all in our heads. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain originating from Lyme disease. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for the Treatment of Upper and Lower Extremity Neuropathic Pain due to Lyme Disease. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Clinical definitions and differential diagnosis of Lyme arthritis. [2013]