Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Complex Regional Pain Syndromes; Neuropathic Pain; Failed Back Surgery Syndrome
• Intervention / Treatment: Device: HD Study Electrode

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

The subjects will be Albany Medical Center functional neurosurgery patients with chronic pain who are undergoing a spinal cord stimulation procedure. The subject population will include 12 adults ≥ 18 years old.

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
McGill Pain Questionnaire (MPQ)	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.	3 month
Oswestry Disability Index (ODI)	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.	3 months
Pain Catastrophizing Scale (PCS)	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.	3 months
Beck Depression Index (BDI)	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	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PainDetect	Ensures patient's pain is neuropathic in nature	Baseline

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; Spinal cord stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Back Pain; Syndrome; Chronic Pain; Neuralgia; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Failed Back Surgery Syndrome
• Other Study ID Numbers: 6426 Microleads

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No