Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

HD Study Electrode

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.