NCT04571242: NOVA

SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)

Completed NA Results posted Last updated 15 July 2024

What this trial tests

NA trial testing DTM Programming in Chronic Back Pain in 126 participants. Completed in 12 April 2023.

Timeline

11 August 2020

Primary endpoint
17 August 2022

12 April 2023

Quick facts

Lead sponsor	SGX Nova LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	11 August 2020
Primary completion	17 August 2022
Estimated completion	12 April 2023
Sites	1 location across United States

Drugs / interventions tested

• DTM Programming
• Conventional SCS programming

Conditions studied

• Chronic Back Pain — all drugs for Chronic Back Pain →

Sponsor

SGX Nova LLC

Who can join

18 and older, any sex, with Chronic Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy Primary · 3 months

The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.

Group	Value	95% CI
DTM-SCS Programming Group	93.5	81.6 – 97.9
Conventional SCS Programming Group	36.4	23.6 – 51.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DTM-SCS Programming Group

Serious: 1/51 (2%)

Deaths: 0/51

Conventional SCS Programming Group

Serious: 2/54 (4%)

Deaths: 0/54

Serious adverse events (3 terms)

Reaction	System	DTM-SCS Programming Group	Conventional SCS Programmi…
Spinal Epidural Hematoma	Musculoskeletal and connective tissue disorders	—	—
Post Dural Puncture Headache	Nervous system disorders	—	—
Pocket Pain	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Spinal Epidural Hematoma, Post Dural Puncture Headache, Pocket Pain.

Data from ClinicalTrials.gov NCT04571242 adverse events section.

Sponsor's own description

This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.

The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Network Meta-analysis and Economic Evaluation of Neurostimulation Interventions for Chronic Nonsurgical Refractory Back Pain.
   Eldabe S, Nevitt S, Bentley A, Mekhail NA, et al · · 2024 · cited 15× · PMID 38751011 · DOI 10.1097/ajp.0000000000001223
2. Twelve-month results from a randomized controlled trial comparing differential target multiplexed spinal cord stimulation and conventional spinal cord stimulation in subjects with chronic refractory axial low back pain not eligible for spine surgery.
   White T, Justiz R, Almonte W, Micovic V, et al · · 2024 · cited 11× · PMID 39229594 · DOI 10.1016/j.xnsj.2024.100528