Intraoperative Neuromonitoring Recording With a Novel SCS Paddle

Chronic Pain Clinical Trial

Official title:

Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045625
• Other study ID #: Microleads 5151
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: March 20, 2021

Study information

• Verified date: February 2023
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• Failed Back Surgery Syndrome
• Neuralgia
• Neuropathic Pain
• Reflex Sympathetic Dystrophy
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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