Study on the Use of Intraoperative Neurophysiological Monitoring in Spinal Cord Stimulator Trials

NCT05540756 | Withdrawn

• 1 other identifier: IRB22-0275
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational pilot study. The spinal cord stimulator (SCS) procedure and neuromonitoring device is not under investigation. Neuromonitoring is typically performed on this patient population receiving SCS trials here. This study is collecting the data that is transmitted into EPIC from the device that is being collected as part of the patients standard of care. This study will specifically look at Boston Scientific SCS trials as those are the majority of SCS devices that are used here at this medical center Primary Objective - To evaluate the difference between observed intraoperative neuromonitoring readings and patient reported coverage for spinal cord stimulator trials and Secondary Objective(s) -

1. 1.To evaluate the safety and tolerability of intraoperative neuromonitoring during spinal cord stimulator trials and via documented adverse events and patient elicited feedback on follow up questionnaires.
2. 2.Patient satisfaction using PGIC from one week to 6-months post procedure
3. 3.Change in pain intensity using NRS from baseline to 6-months post procedure

Conditions

Pain, Chronic; Lumbar Radiculopathy; SCS

Keywords

Spinal Cord Stimulator; Neuromonitoring; Lumbar radiculopathy; ELECTROMYOGRAPHY; Lumbar Pain; Muscle Action Potential; Intraoperative Neurophysiological Monitoring

Outcome Measures

Primary Outcomes (1)

• Spinal Cord Stimulator (SCS) Coverage

  Compare SCS coverage between intraoperative neuromonitoring readings and subject self-report. By testing 18 different muscle groups and then asking the subject to self-report the same muscle groups after they are awake.

  2 Weeks

Secondary Outcomes (2)

• Numerical Rating Scale (NRS)

  2 Weeks

• Patient Global Impression of Change (PGIC)

  2 Weeks

Study Arms (1)

SCS

Patients undergoing a spinal cord stimulator trial who is planning to have intraoperative neuromonitoring performed during the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a SCS trial as part of thier standard of care who are diagnosed with lumbar radiculopathy.

You may qualify if:

• Diagnosis of Lumbar Radiculopathy
• Expected to receive a Spinal Cord Stimulator trial at at the university of Chicago Medical Center

You may not qualify if:

• Subject is part of a vulnerable population.
• Cannot consent for themselves

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Chronic Pain; Radiculopathy; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain

Study Officials

• Magdalena Anitescu, MD PHD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: December 10, 2022
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

US (1)