Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

Albany Medical College

Status: Completed

Conditions: Complex Regional Pain Syndromes; Neuropathic Pain; Chronic Pain; Failed Back Surgery Syndrome

Treatments: Device: HD Study Electrode

Study type: Interventional

Funder types: Other

Identifiers

NCT05459324

6426 Microleads

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing a spinal cord stimulation procedure for neuropathic pain.
• have undergone a successful SCS trial and are determined eligible for a permanent SCS implant.
• Patients must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.-
• subjects must be able to give informed consent.

Exclusion criteria

• patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Study Group

Experimental group

Description:

Twenty-four patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care

Treatment:

Device: HD Study Electrode