Nociscan for Discogenic Low Back Pain

(CLARITY Trial)

Recruiting at 5 trial locations

Overseen By Andy Murillo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aclarion

Disqualifiers: Spinal stenosis, Motor deficit, Spondylolisthesis, Scoliosis, others

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

Compensation: Varies

Number of Visits: 3

Duration: Varies per patient

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called NOCISCAN, which uses MR spectroscopy to help doctors identify which discs in the lower back cause pain. The goal is to assess the safety and effectiveness of NOCISCAN by comparing surgical outcomes with and without the tool's reports. Individuals diagnosed with disc-related back pain who have tried non-surgical treatments for at least six months without success might be suitable candidates. The trial compares two groups: one where doctors review the NOCISCAN results before surgery and one where they do not. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since participants must have failed at least 6 months of non-operative treatment, it might be possible to continue some medications. Please consult with the trial coordinators for specific guidance.

What prior data suggests that NOCISCAN is safe for use in diagnosing discogenic low back pain?

Research shows that Nociscan is a safe and noninvasive tool that uses a special type of MRI to help doctors identify painful discs in the lower back. Previous studies have not identified any major safety issues with Nociscan. As a software tool that doesn't involve medication or physical procedures, it is generally well-tolerated. No reports have linked negative effects directly to this software. This makes it a promising option for those seeking to understand their back pain without the risks of more invasive methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Nociscan for discogenic low back pain because it offers a novel approach to diagnosing the source of pain. Unlike traditional methods like MRI or X-ray, which often struggle to pinpoint discogenic pain specifically, Nociscan uses advanced imaging technology to provide a clearer picture of the pain source. This could lead to more accurate treatments, as doctors can tailor interventions more precisely to the affected discs. By improving diagnosis, Nociscan has the potential to enhance patient outcomes and reduce reliance on broad-spectrum treatments that may not be as effective.

What evidence suggests that Nociscan is effective for discogenic low back pain?

Studies have shown that Nociscan can effectively identify painful discs in the lower back using a special type of MRI. Research indicates that treatments based on Nociscan’s findings resulted in an 85% success rate in surgeries for low back pain caused by disc issues after two years. This trial will compare two approaches: one where the investigator is blinded to the Nociscan results and another where the investigator is unblinded. This tool helps doctors distinguish between painful and non-painful discs, leading to better surgical outcomes. Early findings suggest that using Nociscan improves recovery at 6, 12, and 24 months for those with this type of back pain. Thus, Nociscan could be a promising tool for guiding treatment plans to achieve better outcomes. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with discogenic low back pain, who have not improved after at least 6 months of non-surgical treatments. They must be planning to undergo spine surgery using FDA-approved devices and have specific scores on pain and disability assessments. Pregnant individuals or those unable to follow the study protocol are excluded.

Inclusion Criteria

I plan to have surgery for my back pain not related to this study.

My back pain severely limits my daily activities.

Subject has signed the IRB approved Informed Consent Form

Exclusion Criteria

Subject is contraindicated for a standard lumbar MRI exam

Subject is currently receiving worker's compensation or is involved in any litigation for personal injury, medical negligence, trauma, or worker's compensation

I have a diagnosed spine condition confirmed by X-rays.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

NOCISCAN is completed pre-operatively to distinguish between painful and nonpainful discs in the lumbar spine

1-2 weeks

Treatment

Participants undergo surgical treatment for discogenic low back pain, with blinded and unblinded cohorts compared

Varies per patient

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

24 months

Follow-up visits at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Nociscan

Trial Overview The trial examines NOCISCAN, a software tool that uses MR spectroscopy to differentiate between painful and nonpainful spinal discs. It aims to see if knowing which discs are causing pain before surgery leads to better outcomes than not having this information.

How Is the Trial Designed?

Group I: Unblinded-to-NOCISCAN Experimental Treatment 1 Intervention

NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment.

Group II: Blinded-to-NOCISCAN Experimental Treatment 1 Intervention

NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result.

Who Is Running the Clinical Trial?

Aclarion

Lead Sponsor

Trials

1

Recruited

300+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Published Research Related to This Trial

Percutaneous biacuplasty has strong evidence (Level I) supporting its efficacy in treating chronic, refractory discogenic pain, making it a recommended first-line treatment option based on the review of 49 studies, including 4 randomized controlled trials (RCTs).

Intradiscal electrothermal therapy (IDET) shows moderate evidence (Level III) for efficacy in treating the same condition, while the evidence for discTRODE is limited (Level V), indicating that more research is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain. Helm Ii, S., Simopoulos, TT., Stojanovic, M., et al.[2019]

Citations

1. investors.aclarion.com investors.aclarion.com/news/aclarion-announces-publication-of-2yr-outcomes-in-groundbreaking-clinical-trial

Aclarion Announces Publication of 2YR Outcomes in ... Success rate at 2 years for discogenic low back pain surgeries was 85% for patients whose treatment strategy was consistent with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04015791?term=AREA%5BConditionSearch%5D(Leigh%20syndrome%20OR%20%22infantile%20necrotizing%20encephalomyelopathy%22%20OR%20%22%20infantile%20subacute%20necrotizing%20encephalopathy%22%20OR%20%22%20juvenile%20subacute%20necrotizing%20encephalomyelopathy%22%20OR%20%22%20Leigh%20disease%22%20OR%20%22%20Leigh%20syndrome%20spectrum%22%20OR%20%22%20Leigh's%20disease%22%20OR%20%22%20LS%22%20OR%20%22%20LSS%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=9

NOCISCAN-Lumbar Spine (LS) Clinical Evaluation Study Clinical Evaluation of NOCISCAN-Lumbar Spine ( LS ) Disc MR Spectroscopy (MRS) for Diagnosis of Discogenic Low Back Pain and Correlation With Surgical Outcomes.

3. withpower.com withpower.com/trial/phase-back-pain-11-2024-cb727

Nociscan for Discogenic Low Back Pain (CLARITY Trial) This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37014434/

Magnetic resonance spectroscopy (MRS) identification of ... Magnetic resonance spectroscopy (MRS) identification of chemically painful lumbar discs leads to improved 6-, 12-, and 24-month outcomes for discogenic low back ...

5. investors.aclarion.com investors.aclarion.com/news/aclarion-to-present-2-year-follow-up-data-on-pivotal-clinical-trial-linking-nociscan-to-better-surgical-outcomes-for-discogenic-low-back-pain

Aclarion to Present 2-year Follow Up Data on Pivotal ... Aclarion to Present 2-year Follow Up Data on Pivotal Clinical Trial Linking Nociscan to Better Surgical Outcomes for Discogenic Low Back Pain.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38413238/

Establishing a Gold Standard for Noninvasive Identification ... NOCISCAN is an adoptable, noninvasive, and objectively quantitative test to improve management of low back pain patients.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06661850/examination-of-nociscan-impact-on-discogenic-low-back-pain-surgical-outcomes

Examination of Nociscan Impact on Discogenic Low Back ... This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance ...

8. ctv.veeva.com ctv.veeva.com/study/examination-of-nociscan-impact-on-discogenic-low-back-pain-surgical-outcomes

Examination of Nociscan Impact on Discogenic Low Back ... This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy.