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Intraoperative Neuromonitoring Recording With a Novel SCS Paddle

Primary Purpose

Chronic Pain, Neuropathic Pain, Failed Back Surgery Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HD Study Electrode
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Chronic Pain focused on measuring Spinal cord stimulation, chronic pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing a spinal cord stimulation procedure for neuropathic pain
  • 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

Sites / Locations

  • Albany Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Twelve 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

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS)
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

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.
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.
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.
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

Full Information

First Posted
September 7, 2021
Last Updated
February 6, 2023
Sponsor
Albany Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05045625
Brief Title
Intraoperative Neuromonitoring Recording With a Novel SCS Paddle
Official Title
Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albany Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Neuropathic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes
Keywords
Spinal cord stimulation, chronic pain

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Twelve 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
Intervention Type
Device
Intervention Name(s)
HD Study Electrode
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
McGill Pain Questionnaire (MPQ)
Description
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.
Time Frame
3 month
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
3 months
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
3 months
Title
Beck Depression Index (BDI)
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing a spinal cord stimulation procedure for neuropathic pain 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
Facility Information:
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

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Intraoperative Neuromonitoring Recording With a Novel SCS Paddle

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