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

NCT05540756 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-04-28

No results posted yet for this study

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. 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. Patient satisfaction using PGIC from one week to 6-months post procedure
3. Change in pain intensity using NRS from baseline to 6-months post procedure

This study will follow subjects in conjunction with thier standard of care SCS clinic visits. This includes the one week wound check at the pain clinic and then a 2 week end of study phone call.

Conditions

  • Pain, Chronic
  • Lumbar Radiculopathy
  • SCS

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Magdalena Anitescu, MD PHD · University of Chicago

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-10
Primary Completion
2022-12-10
Completion
2022-12-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05540756 on ClinicalTrials.gov