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

A prospective, double blinded, multi-center study to assess the validity and clinical utility of the pre-operative NOCISCAN-LS software in the identification of painful lumbar discs, and the correlation with improved surgical outcomes at 3, 6, 12 and 24 months (follow-up) following spine surgery in a single enrollment arm of subjects with chronic symptomatic single level degenerative disc disease (DDD) at L3 to S1, but with two evaluation groups- Match Group and Miss Group,of subjects based on the association between the NOCISCORE results of treated and untreated disc levels.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Disc Disease
• Intervention / Treatment: Other: NOCISCAN-LS Disc MR Spectroscopy

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Ryan Bond; Phone Number: 650-241-1741; Email: rbond@nocimed.com

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Back Institute
      • Contact: Donna Ohnmeiss; Email: dohnmeiss@texasback.com
      • Principal Investigator: Jack Zigler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Up to 240 subjects that are approved and scheduled for surgery at a single level from L3 to S1 to treat chronic, severe, primary axial, discogenic, low back pain via maximum of 14 sites

Description

Inclusion Criteria:

1. Has history consistent with degenerative disc disease as noted by back pain of discogenic origin with or without leg pain

2. Has one of more of the following conditions as documented by CT or MRI and plain X-rays:

   1. Modic changes
   2. High intensity zones in the annulus
   3. Loss of discogenic height
   4. Decreased hydration of the disc
3. Has single level symptomatic degenerative involvement from L3 to S1 in which surgical treatment is indicated
4. Skeletally mature male or female (non-pregnant) between 18 and 70 years of age
5. Pre-operative score ≥ 40% on Oswestry Disability Index
6. VAS back pain score ≥ 40 mm and that is greater than the VAS leg pain scores
7. Patient has failed at least ≥6 months of non-operative treatment that may have included physical therapy, bed rest, anti-inflammatory or analgesic medications, chiropractic care, acupuncture, massage therapy or home-directed lumbar exercise programs
8. In subject who receives pre-operative provocative discography (PD), the PD was performed more than 6 week prior to the scheduled NOCISCAN- LS Exam OR Is scheduled to be conducted after the Nociscan exam
9. Subject is willing to sign an Institutional Review Board approved Informed Consent and HIPAA Authorization forms, and is physically and mentally able to complete study forms and otherwise willingly adhere to the requirements of the protocol in the opinion of the investigator

Exclusion Criteria:

1. Has primary diagnosis of spinal condition other than degenerative disc disease at the involved level;
2. Has had prior lumbar back surgery or intradiscal treatments at any lumbar level (Note: diagnostic provocative or anesthetic discography are not excluded; micro-discectomy +- laminectomy patients greater than 6 months postop are not excluded)
3. Surgery planned at more than one level

4. Radiographic evidence of clinically relevant lumbar vertebral abnormalities, including

   • Greater than Grade 1 spondylolisthesis according to Meyerding classification at the involved level;
   • Any posterior lumbar element insufficiency (e.g. Spondylolysis, pars fracture, or prior facet resection;
   • Lumbar scoliosis with a Cobb angle of greater than 11 degree
   • Symptomatic kyphosis or flat black syndrome
   • Evidence of prior fracture or trauma to the L1, L2,L3, L4 or L5 levels in either compression or burst; Note: Modic end plate changes will not be excluded
5. Radiographic evidence of lumbar disc herniation with extrusion
6. Clinically significant spinal canal stenosis as assessed by the Investigator
7. Any significant motor strength deficit in lower extremities
8. Suspicion of Sacro Iliac and/ or Facet joint pain as the primary pain generator;
9. Has a condition that requires post-operative medications that interfere with fusion, such as immunosuppressive drugs, steroids or prolonged use of non-steroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation
10. Has active bacterial infection, either local or systemic and/or potential for bacteremia
11. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin) during the past 5 years
12. Chronic disease (other than degenerative disc disease), chronic pain syndrome (other than discogenic low back pain), or psychological dysfunction, which may , in the opinion of the Investigator compromise a subject's ability to comply with study procedures, and/ or may confound data;
13. Applicable exclusionary criteria for standard lumbar MRI exam;
14. Has pending litigation, except where required by the insurer as condition of coverage;
15. BMI > 40kg/m2

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Match Group; Surgery conducted at the disc level corresponding with the highest level of NOCISCORE value in the subject and that is classified as either NOCI + or NOCI mild	Other: NOCISCAN-LS Disc MR Spectroscopy; The investigational Nociscan Suite is a software suite that works with existing high field MR systems and MRS pulse sequence via and optimized protocol to conduct MRS exam of lumbar discs. The software suite post-processes the NOCISCAN-LS disc MRS exam data to calculate ratios of spectroscopic signals at regions along the MRS frequency spectrum associated with certain chemicals that change with degeneration and pain; Other Names: MR Spectroscopy (MRS)
Miss Group; Surgery conducted at a disc that: (a) corresponds with a low relative NOCISCORE value in the subject and that is classifies as NOCI - or (b) excludes the disc level with the highest NOCISCORE value in the subject and that is classifies as NOCI+ or NOCI mild	Other: NOCISCAN-LS Disc MR Spectroscopy; The investigational Nociscan Suite is a software suite that works with existing high field MR systems and MRS pulse sequence via and optimized protocol to conduct MRS exam of lumbar discs. The software suite post-processes the NOCISCAN-LS disc MRS exam data to calculate ratios of spectroscopic signals at regions along the MRS frequency spectrum associated with certain chemicals that change with degeneration and pain; Other Names: MR Spectroscopy (MRS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index Assessment to assess improvement in lumbar pain	Oswestry Disability Index is an index derived from Oswestry Low Back Pain Questionnaire used in several studies to quantify disability for low back pain. Each of the 10 items is scored from 0-5. The maximum score is therefore 50. This will be completed at 12 month follow up to see if there is an improvement of at least 15 points at 12 months Follow-up for Match Group versus Miss Group subjects. Mean Oswestry Disability Index score changes at 3, 6 and 24 months post-operative follow-up will be evaluated for Match versus Miss Group	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) to assess the intensity of pain	Visual Analog Scale for pain is a validated tool used in determining the subjective level of pain in an individual. It will be completed at Mean Visual Analog Scale score changes for back pain at 3,6, 12 and 24 months post-op follow up for Match versus Miss Group	2 years
Demonstrate correlation of NOSCISCORE results to Provocative Discography +/- results in subset of study subjects that receive pre-operative provocative discogram	Compare NOCISCORE results for Provocative discography positive discs versus Provocative discography negative discs in study subjects receiving pre-operative discogram	24 months

Collaborators and Investigators

• Sponsor: Nocimed, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 29, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: MR Spectroscopy; lumbar disc disease; Nociscan
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
• Other Study ID Numbers: NM005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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