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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Sana Pain Reliever to determine its effectiveness in reducing chronic pain in people with Lyme disease. The device, worn over the eyes and ears, uses light pulses and sounds to potentially ease pain. Participants will use either the active device or a sham (inactive) version for comparison. The trial seeks individuals diagnosed with chronic pain from Lyme disease who meet specific criteria related to their medical history and symptoms. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new pain relief options for Lyme disease patients.

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 prior data suggests that the Sana Device is safe for reducing chronic pain from Lyme Disease?

Research has shown that the Sana Pain Reliever, a device designed to reduce chronic pain from Lyme disease, is undergoing careful safety evaluation. The FDA has not yet approved the device, so more safety data is being collected.

Early results suggest the device is non-invasive, as it does not involve surgery or medication. It uses light and sound to potentially aid in pain relief. Studies on similar devices have shown improvements in pain levels with few side effects, but specific data on the Sana Pain Reliever remains limited. Generally, this type of device carries a low risk of serious side effects because it does not involve drugs or surgery.

In summary, while the Sana Pain Reliever might be safe and easy to use, more information from ongoing studies is needed for confirmation. Prospective trial participants should consider this information and consult their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Sana Pain Reliever is unique because it uses an innovative device approach to address chronic pain from Lyme disease. Unlike traditional treatments that often involve medications or invasive procedures, this device offers a non-invasive option that could reduce pain through advanced technology settings. Researchers are excited about its potential to provide relief without the side effects typically associated with pain medications, offering a promising alternative for those who struggle with conventional therapies.

What evidence suggests that the Sana Device is effective for chronic pain from Lyme Disease?

Research shows that the Sana Pain Reliever (Sana PR) device might help reduce chronic pain using pulsing lights and sounds. Participants in this trial will be assigned to either the Real Arm, experiencing the active device settings, or the Sham Arm, experiencing the sham device settings. The device is worn over the eyes and uses these lights and sounds to interact with the brain. It also monitors heart rate variability (HRV), which might help track changes in pain levels. Although the FDA has not yet approved the device, it is designed to ease pain by affecting brain activity. Early signs suggest that combining light and sound therapy could be promising for managing chronic pain, including pain from Lyme disease. ^{1 3 6 7 8}

Who Is on the Research Team?

David Putrino, PT, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06655844

Sana Device for Post-Treatment Lyme Disease Syndrome ... 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06655844/sana-device-for-post-treatment-lyme-disease-syndrome-chronic-pain

Sana Device for Post-Treatment Lyme Disease Syndrome ... This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain. The Sana PR is a device ...

3. withpower.com withpower.com/trial/phase-lyme-disease-9-2024-87d45

Sana Device for Chronic Pain from Lyme Disease 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 ...

4. lymectn.org lymectn.org/Studies.aspx

Current Studies Sana Health Clinical Trial. This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain. The Sana PR is a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04280562

Remote Participation (Within USA) Trial of Sana Pain ... This will be a randomized, sham-controlled trial that will investigate the effectiveness of a novel wearable device called the Sana Pain Reliever (Sana PR) at ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT06655844

Sana Device for Post-Treatment Lyme Disease Syndrome ... 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04280562

Remote Participation (Within USA) Trial of Sana Pain ... This will be a randomized, sham-controlled trial that will investigate the effectiveness of a novel wearable device called the Sana Pain Reliever (Sana PR) at ...

8. reports.mountsinai.org reports.mountsinai.org/article/rehab2025-02-av-stim-for-neuropathic-pain

A Novel Neuromodulation Device for Neuropathic Pain Both groups—those treated with the Sana Health device and those who received a sham treatment—showed statistically significant pain score improvements at 10 ...