Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

Not Applicable

Completed

• Conditions: Failed Back Surgery Syndrome; Chronic Pain; Neuropathic Pain; Complex Regional Pain Syndromes
• Interventions: Device: HD Study Electrode

• Registration Number: NCT05459324
• Lead Sponsor: Albany Medical College

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-08
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	HD Study Electrode	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

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	3 months	Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Index (BDI)	3 months	This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63
McGill Pain Questionnaire (MPQ)	3 month	Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15.
Oswestry Disability Index (ODI)	3 months	This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100.
Pain Catastrophizing Scale (PCS)	3 months	Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52.

Trial Locations

Locations (1)

Albany Medical College; 🇺🇸 Albany, New York, United States