Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes (CLARITY)

A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain

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. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient."

Study Overview

• Status: Recruiting
• Conditions: Discogenic Low Back Pain
• Intervention / Treatment: Procedure: Fusion or TDR determined by investigator.

• Study Type: Observational
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan Bond; Phone Number: 724-991-3369; Email: rbond@aclarion.com
• Study Contact Backup: Name: Andy Murillo; Email: amurillo@aclarion.com

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Recruiting
      • Todd H. Lanman, M.D Inc
      • Principal Investigator: Todd Lanman, MD
      • Contact: Nicole Phillips; Phone Number: 310-385-7766; Email: research@spine.md
    • La Jolla, California, United States, 92037
      • Recruiting
      • Scripps Health
      • Contact: Joy Biggers; Phone Number: 354-5273 858-554-5273; Email: Biggers.joy@scrippshealth.org
      • Principal Investigator: Hani Malone, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC Keck Medical Center
      • Contact: Edgar Martinez Sanchez; Phone Number: 323-442-5300; Email: edgar.msanchez@med.usc.edu
      • Principal Investigator: Patrick Hsieh, MD
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami/ Jackson Health System
      • Contact: Adriana Saravia; Phone Number: 305-243-3048; Email: a.saravia@med.miami.edu
      • Principal Investigator: Gregory Basil, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Lidia Hrvojevic; Phone Number: 312-695-4463; Email: lidia.hrvojevic@nm.org
      • Principal Investigator: Alpesh Patel, MD
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • Advocate Aurora Research Institute
      • Contact: Victor Arroyo; Phone Number: 847-723-7950; Email: victor.arroyo@aah.org
      • Principal Investigator: Patrick Sugrue, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Medicine
      • Contact: Daniel Davidar; Phone Number: 6673067925; Email: adavida1@jhmi.edu
      • Principal Investigator: Daniel Lubelski, MD
  • Texas
    • Plano, Texas, United States, 75093
      • Recruiting
      • Texas Back Institute
      • Contact: Shannon Rusch; Phone Number: 972-608-5181; Email: srusch@texasback.com
      • Principal Investigator: Alexander Satin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with back pain potentially caused by lumbar degenerative disc disease. Patients may be symptomatic at one level or two levels. Patients must be indicated for surgical treatment of their discogenic low back pain. Patients must also meet all study inclusion criteria and none of the study exclusion criteria.

Description

Inclusion Criteria:

1. Subject is a skeletally mature male or female (non-pregnant) aged 18 to 70 years (inclusive);
2. Subject plans to undergo surgical treatment of their discogenic back pain independent of this research protocol;
3. Subject is to be treated with on-label use of FDA-cleared or FDA-approved devices independent of this research protocol;
4. Subject has a diagnosis of discogenic back pain that requires treatment in up to two lumbar levels caused by degenerative disc disease (identified via MRI);
5. Subject has a preoperative Oswestry Disability Questionnaire score ≥35 out of 100 points (35/100);
6. Subject has a VAS back pain score of ≥40mm and that is greater than the worst VAS leg pain score;
7. Subject has failed at least ≥ 6 months of non-operative treatment (for example: physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs) OR requires urgent surgical treatment per the investigator;
8. Subject has signed the IRB approved Informed Consent Form; and
9. Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.

Exclusion Criteria:

1. Subject has a primary diagnosis of spinal condition other than degenerative disc disease at the involved level (i.e., facet joint pain/SI pain);
2. Subject has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy, decompression, or laminectomy patients greater than 6 months postop are not excluded);
3. Surgery is planned for more than 2 lumbar levels.
4. Subject has severe spinal canal stenosis as assessed by the Investigator;
5. Subject has a motor strength deficit(s) in lower extremities

6. Subject has a lumbar spine diagnosis, based on radiographic evidence, of clinically relevant lumbar vertebral abnormalities (except Modic end-plate changes, which are not excluded), including:

   • Spondylolisthesis Grade 2 or greater (up to Grade 1 is accepted)
   • Pars fracture, at the involved level
   • Spondylolysis
   • Lumbar scoliosis with a Cobb angle of greater than 15°
   • Evidence of prior fracture or trauma to the L1, L2, L3, L4, or L5 levels in either compression or burst
   • Lumbar kyphosis
7. Subject has radiologic evidence of an uncontained lumbar disc herniation or lumbar disc extrusion.
8. Subject is contraindicated for a standard lumbar MRI exam
9. Women who are currently pregnant (or believe they may be at risk of being or becoming pregnant), or are breast feeding, during the study period when scans will be performed
10. Subject is currently receiving worker's compensation or is involved in in any litigation for personal injury, medical negligence, trauma, or worker's compensation.
11. Subject has a chronic disease (other than degenerative disc disease), chronic pain (other than discogenic low back pain), or psychological dysfunction, which may, in the opinion of the Principal Investigator, compromise a subject's ability to comply with study procedures, and/or may confound data
12. Subject has a BMI > 40

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blinded-to-NOCISCAN; NOCISCAN completed pre-operatively. Investigator will not have access to NOCISCAN result.	Procedure: Fusion or TDR determined by investigator.; The surgical treatment will be decided by the treating investigator based on their clinical judgement.
Unblinded-to-NOCISCAN; NOCISCAN completed pre-operatively. Investigator will have access to the NOCISCAN result after completing initial treatment plan but before treatment.	Procedure: Fusion or TDR determined by investigator.; The surgical treatment will be decided by the treating investigator based on their clinical judgement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment	The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline. VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
20 mm improvement in back pain on 100mm Visual Analog Scale (VAS) Pain Assessment	VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.	From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
20 mm improvement in worst leg pain on a 100mm Visual Analog Scale (VAS) Pain Assessment	VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.	From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Patient reported treatment satisfaction survey	Patient Satisfaction survey is a self-reported questionnaire to measure the subject's satisfaction of the treatment under the protocol.	Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Patient-Reported Outcome Measurement Information System (PROMIS) 29 score	The PROMIS-29 v2. 0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.	Each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Cumulative proportion of responders (CPRA) for 15 point Oswestry Disability Index (ODI) change (out of 100)	The Oswestry Disability Index (ODI) is a 10-item questionnaire that scores disability on a percentile scale from 0-100%. The ODI score is interpreted as follows: 0-20%: Minimal disability 20-40%: Moderate disability 40-60%: Severe disability 60-80%: Crippling effects 80-100%: Completely disabled and bedbound	From Baseline to each follow up visit (3-Months, 6-Months, 12- Months, and 24 Months)
Absence of Secondary surgical intervention	Secondary surgical interventions may include revision, reoperation, removal or supplemental fixation at any level in the lumbar spine.	From Baseline through study completion, 24-Months
Correlation of preoperative NOCISCAN Biomarkers with preoperative Visual Analog Scale (VAS) Pain Assessment Scores	VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain. Higher scores closer to the extreme pain range indicate worse outcome.	From Baseline through study completion, 24-Months

Collaborators and Investigators

• Sponsor: Aclarion
• Collaborators: MCRA

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: MRI; back pain; MR Spectroscopy; Nociscan
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Genetic Phenomena; Recombination, Genetic; Gene Fusion
• Other Study ID Numbers: Clarity

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No