- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05045625
Intraoperative Neuromonitoring Recording With a Novel SCS Paddle
February 6, 2023 updated by: Albany Medical College
Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Albany, New York, United States, 12208
- Albany Medical College
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Group
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Rating Scale (NRS)
Time Frame: 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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
McGill Pain Questionnaire (MPQ)
Time Frame: 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.
|
3 month
|
Oswestry Disability Index (ODI)
Time Frame: 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.
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3 months
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Pain Catastrophizing Scale (PCS)
Time Frame: 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.
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3 months
|
Beck Depression Index (BDI)
Time Frame: 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
|
3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2020
Primary Completion (Actual)
March 20, 2021
Study Completion (Actual)
March 20, 2021
Study Registration Dates
First Submitted
September 7, 2021
First Submitted That Met QC Criteria
September 7, 2021
First Posted (Actual)
September 16, 2021
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
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
- Microleads 5151
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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