Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

NCT05459324 | Completed DMC FDA Device

• 1 other identifier: 6426 Microleads
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Spinal cord stimulation; chronic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• McGill Pain Questionnaire (MPQ)

  3 month

• Oswestry Disability Index (ODI)

  3 months

• Pain Catastrophizing Scale (PCS)

  3 months

• Beck Depression Index (BDI)

  3 months

Other Outcomes (1)

• PainDetect

  Baseline

Study Arms (1)

Study Group

EXPERIMENTAL

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

Interventions

HD Study Electrode DEVICE

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.

Study Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

Related Publications (1)

• Berwal D, Quintero A, Telkes I, DiMarzio M, Harland T, Paniccioli S, Dalfino J, Iyassu Y, McLaughlin BL, Pilitsis JG. Improved Selectivity in Eliciting Evoked Electromyography Responses With High-Resolution Spinal Cord Stimulation. Neurosurgery. 2024 Aug 1;95(2):322-329. doi: 10.1227/neu.0000000000002878. Epub 2024 Feb 20.

  PMID: 38376181 DERIVED

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Failed Back Surgery Syndrome; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Back Pain; Autonomic Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Statistics will be performed comparing the HR-SCS to commercial SCS devices. Additionally, we will correlate patient reported outcomes and spinal measurements to IONM outcomes to determine overall device capabilities.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 14, 2022
• Study Start: June 8, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (1)