NCT04015791

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Nocimed, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Lumbar Disc Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-09-30
• Completion: 2025-12-31
• First posted: 2019-07-11
• Last updated: 2022-07-29

Locations

1 site across 1 country: United States