NCT05659836

Spinal Cord Stimulation Trial to Permanent Prediction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Spinal Cord Stimulation Trial to Permanent Prediction is a prospective, longitudinal, multi-center, non-randomized, multi-arm, open-label, clinical feasibility study designed to investigate whether objective data collected from chronic pain patients is predictive of subjective patient-reported outcomes and of adjustments to patient programming parameters.

Detailed description

The study will enroll up to 60 subjects at 10 sites in the United States. Follow-up will continue for a period of 6 months post-trial for subjects who choose not to receive a permanently-implanted system as well as 6 months post implant for subjects receiving a permanent implant.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Abbott SCS Systems	Patients will be implanted with Abbott spinal cord stimulation (SCS) systems (both trial and permanently-implanted systems) and provided with wearable sensors, and software applications presented on a mobile device.

Timeline

• Start date: 2021-05-27
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2022-12-21
• Last updated: 2023-09-26

Locations

7 sites across 1 country: United States