Study on the Use of Intraoperative Neurophysiological Monitoring in Spinal Cord Stimulator Trials (SCS-Monitor)

Single-center, Observational Pilot Study on the Use of Intraoperative Neurophysiological Monitoring in Spinal Cord Stimulator Trials

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Chronic; Lumbar Radiculopathy; SCS

Detailed Description

Spinal cord stimulation (SCS) is a neuromodulation procedure that utilizes electrical stimulation via electrodes on the spinal cord for management of various chronic pain states. The most common indications for SCS placement include refractory neuropathic pain, complex regional pain syndromes (CRPS), post-laminectomy/failed back surgery syndrome, and ischemic limb pain related to peripheral vascular disease.1 Upon placing the percutaneous leads in the epidural space, the electrodes or the leads are activated with electrical currents and the patient is asked to report area of paresthesia in response to stimulation.

1. Hypothesis This study hypothesizes that one will be able to use percutaneous SCS leads and be able to properly map the dermatomal overlap with the myotomes recorded during the procedure using CMAP.
2. Objectives

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

Primary Study Endpoints The primary study endpoints will be the comparison between intraoperative neuromonitoring readings and patient reported coverage for spinal cord stimulator trials. This study will collect asleep tonic and sub-perception burst waveforms, as well as awake tonic and sub-perception burst waveforms. Also collected will be self-reported subject pain coverage with the subject awake and conversant.

2.5 Secondary Study Endpoints To evaluate the safety and tolerability of intraoperative neuromonitoring during spinal cord stimulator trials via documented adverse events and patient elicited feedback via NSR and PGIC.

SCS Neuromonitoring:

Subjects will be seen on the day of their procedure in the preoperative holding area. Once consent has been given, the patient will be taken to the OR and attached to monitors.

Once the subject is sedated, the IONM specialist will place subdermal needle electrodes in various muscle groups and begin testing to obtain baseline measurements. The muscle groups that will be monitored bilaterally are as follows: upper and lower intercostals, upper and lower abdomen, iliopsoas, vastus lateralis, biceps femoris, tibialis anterior, and gastrocnemius. Transcranial electrical stimulation electrodes will also be placed in the scalp with the patient mildly anesthetized to measure SSEPs and MEPs. Once IONM baselines are obtained, SCS leads will be placed.

Testing will begin with IONM with the patient under sedation. Intraoperatively, this study will employ the use of CMAP. After lead placement, the contacts of each lead will be activated with a sub-perception burst waveform and a tonic waveform. The study team will record the parameters and IONM response with the patients under sedation. Once confirmed with the IONM team, the anesthesia team will awaken the patient and cease sedation. With the patient awake, the coordinator will test the same regions while activating the same electrodes with the patient self-reporting their perceived areas of paresthesia. This will be done by asking the subject to confirm that the region being stimulated covers their region of pain.

Subjects will undergo the SCS trial as part of their standard of care and will be seen for follow-up 1 week post-trial, during which the leads will be pulled.

The patient will undergo SCS implant and be admitted for 24-hour postoperative observation. All follow-up visits and SCS procedures are part of standard of care.

Sequence and Duration of all Study Periods Total length for participation in this study is up to 2 weeks

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SCS; Patients undergoing a spinal cord stimulator trial who is planning to have intraoperative neuromonitoring performed during the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS)	Change in pain intensity using NRS from baseline to 2 weeks post procedure. NRS is an 11-point scale where 0 means no pain and 10 means the worst pain imaginable.	2 Weeks
Patient Global Impression of Change (PGIC)	Patient satisfaction using PGIC from baseline to 2 weeks post procedure	2 Weeks

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Magdalena Anitescu, MD PHD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Lumbar Pain; Intraoperative Neurophysiological Monitoring; Spinal Cord Stimulator; Neuromonitoring; Lumbar radiculopathy; ELECTROMYOGRAPHY; Muscle Action Potential
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Radiculopathy
• Other Study ID Numbers: IRB22-0275

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No