NCT04571242

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

Open-Label, Post Market Study: Study the Effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) Programs in Treating Intractable Chronic Back Pain in Subjects Without Prior History of Spine Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: SGX Nova LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach. Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: * Test treatment group with DTM-SCS programming approach * Control treatment group with Conventional SCS programming approach Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study. There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit. Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization. This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint. The expected total duration of this study is approximately 32 months.

Conditions

• Chronic Back Pain

Interventions

Type	Name	Description
DEVICE	DTM Programming	DTM-SCS programming
DEVICE	Conventional SCS programming	Conventional SCS programming

Timeline

• Start date: 2020-08-11
• Primary completion: 2022-08-17
• Completion: 2023-04-12
• First posted: 2020-09-30
• Last updated: 2024-07-15
• Results posted: 2023-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study