NCT05459324

Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording: Phase II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.

Conditions

• Chronic Pain
• Neuropathic Pain
• Failed Back Surgery Syndrome
• Complex Regional Pain Syndromes

Interventions

Type	Name	Description
DEVICE	HD Study Electrode	The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.

Timeline

• Start date: 2022-06-08
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-07-14
• Last updated: 2024-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study