Neurolyser XR for Chronic Low Back Pain

Not currently recruiting at 5 trial locations

Overseen By Michael Gofeld, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: FUSMobile Inc.

Must not be taking: Steroids, Disease modifying drugs

Disqualifiers: Neurological deficits, Spine surgery, Osteoporosis, Malignant disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Neurolyser XR, which uses focused sound waves to treat long-lasting lower back pain. The researchers aim to determine if this non-invasive treatment is safe and feasible for pain relief. The trial targets individuals over 55 who have experienced lower back pain for more than six months and find relief when lying down or sitting comfortably. Participants should also have experienced significant pain relief from previous specific back treatments. As an unphased trial, this study provides a unique opportunity to explore a novel treatment option for those seeking alternative pain relief solutions.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving active treatment for rheumatologic diseases with steroids, disease-modifying drugs, biological agents, or immunosuppressants, you may not be eligible to participate.

What prior data suggests that the Neurolyser XR device is safe for treating chronic low back pain?

Research has shown that focused ultrasound treatments, such as the Neurolyser XR device, are generally safe and effective for treating low back pain. Previous studies indicate that patients tolerate this treatment well. Although specific safety data for the Neurolyser XR itself is not available, similar treatments have not shown any serious side effects.

The Neurolyser XR has a CE Mark, indicating it meets European safety standards for medical devices, which suggests its safety. While detailed safety data is lacking, its approval for use in Europe implies it has undergone some safety testing. This should reassure those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Neurolyser XR device because it uses High Intensity Focused Ultrasound (HIFU) to provide a new way to manage axial chronic low back pain. Unlike traditional treatments like medications and physical therapy, which often focus on symptom relief, Neurolyser XR directly targets the medial nerve branch through thermal ablation. This innovative approach could offer more precise pain relief with potentially longer-lasting effects. By focusing on the nerve branch, this method aims to reduce pain without the need for invasive surgeries or long-term medication use, which could be a game-changer for many patients.

What evidence suggests that the Neurolyser XR is effective for treating chronic low back pain?

Research has shown that the Neurolyser XR, a device using focused sound waves, effectively treats long-term lower back pain. Clinical data indicate that it works similarly to radiofrequency ablation, a well-known treatment. In this trial, participants will receive treatment with the Neurolyser XR, which targets and heats a specific nerve to reduce pain. Studies have reported significant pain relief in patients who received this treatment. This non-invasive method appears promising for those suffering from chronic lower back pain. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients presenting with a) a positive (>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.

You have been experiencing pain in your low back for more than 6 months on either one or both sides.

Your back pain is relieved when you lie down or sit in a comfortable position.

Exclusion Criteria

You are pregnant or currently breastfeeding.

Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded

Patients known for concomitant psychiatric disorders, excluding mood disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Visits at baseline, 2 days, 1, 2 & 4 weeks, 3 & 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Neurolyser XR

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Who Is Running the Clinical Trial?

FUSMobile Inc.

Lead Sponsor

Trials

7

Recruited

170+

Published Research Related to This Trial

The study presents a curated and standardized version of the FDA Adverse Event Reporting System (FAERS) data, which enhances the quality and usability of drug safety surveillance by removing duplicates and standardizing drug and outcome vocabularies.

This new resource will facilitate faster and more reliable drug safety research by providing pre-computed statistics and reducing the time needed for data management, ultimately improving the identification of adverse drug reactions (ADRs) post-marketing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A curated and standardized adverse drug event resource to accelerate drug safety research. Banda, JM., Evans, L., Vanguri, RS., et al.[2020]

A total of 4,766 adverse drug reactions (ADRs) were reported by consumers for nervous system medications, with half of these being serious, including 19 fatalities, highlighting the potential risks associated with these medications.

The majority of ADRs were reported for women (58%) and were primarily linked to antiepileptics (36% of total ADRs), which had the highest proportion of serious reactions (60%), indicating a need for careful monitoring of these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. Aagaard, L., Hansen, EH.[2021]

A study analyzing 3,940 cases from the FDA Adverse Event Reporting System found that taxane-related neurotoxicity, particularly peripheral neuropathy, is common, especially among elderly patients and females.

The median time for neurological adverse effects to appear after taxane treatment was 27 days, with a significant portion of cases occurring within the first 30 days, and the study reported a fatality rate of 6.13% and hospitalization rate of 28.63% for these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017-2021. Zhang, J., Luo, L., Long, E., et al.[2023]

The study found that there is no formal definition of 'adversity' or guidance on determining the No Observed Adverse Effect Level (NOAEL) in safety pharmacology, indicating a lack of standardized practices in this area.

It was concluded that using NOAEL in safety pharmacology is not recommended, as the diverse functional endpoints measured do not fit into a simple toxic/non-toxic classification, suggesting a need for more nuanced risk assessments in drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for the no observed adverse effect level in safety pharmacology? Mow, T., Andersen, NK., Dragsted, N., et al.[2021]

Citations

1.

fusfoundation.org

fusfoundation.org/posts/low-back-pain-clinical-data-show-focused-ultrasound-is-safe-and-effective/

Low Back Pain: Clinical Data Show Focused Ultrasound is ...

The Neurolyser XR HIFU system achieved clinical responses comparable with radiofrequency ablation. ... medial branch nerve. The entire treatment ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05154448

Double Arm Pivotal Study to Evaluate the Neurolyser XR ...

Individual presenting with a) a positive (>80% pain relief) to a previous, double, lumbar medial branch block (within the last 12 months) and/or b) with a ...

3.

rapm.bmj.com

rapm.bmj.com/content/early/2024/04/04/rapm-2024-105345

Fluoroscopy-guided high-intensity focused ultrasound ...

The objective of this study is to investigate safety and effectiveness of a fluoroscopy-guided high-intensity focused ultrasound (HIFU) system for thermal ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06053255

Use of the Neurolyser XR for the Treatment of Low Back ...

The Neurolyser XR is a device used to deliver high-intensity focused ultrasound for the ablation of the lateral sacral branch nerve in patients with ...

5.

thejns.org

thejns.org/focus/view/journals/neurosurg-focus/57/3/article-pE9.pdf

Focused ultrasound for the treatment of facet joint pain

The medial branch nerve and posterior facet joint capsule were the most common targets for focused ablation. Although the energy used ranged from 300 to. 2000 J ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04129034

Safety and Initial Feasibility of Using the Neurolyser XR ...

Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain. ClinicalTrials.gov ID NCT04129034.

7.

withpower.com

withpower.com/trial/phase-back-pain-8-2019-d81c4

Safety and Initial Feasibility of Using the Neurolyser XR ...

What safety data exists for Neurolyser XR or similar treatments? The research articles do not provide specific safety data for Neurolyser XR or similar ...

8.

fusfoundation.org

fusfoundation.org/posts/focused-ultrasound-device-for-low-back-pain-granted-ce-mark/

Focused Ultrasound Device for Low Back Pain Granted CE ...

FUSMobile has announced that its Neurolyser XR device has been granted CE Mark for the treatment of lumbar zygapophyseal joints syndrome.