Pain, ChronicSCS-MonitorNCT05540756
Study on the Use of Intraoperative Neurophysiological Monitoring in Spinal Cord Stimulator Trials
An observational study of Pain, Chronic and Lumbar Radiculopathy, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Lumbar Radiculopathy, SCS
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2022to 10 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing a SCS trial as part of thier standard of care who are diagnosed with lumbar radiculopathy.
Who may be able to join
- Diagnosis of Lumbar Radiculopathy
- Expected to receive a Spinal Cord Stimulator trial at at the university of Chicago Medical Center
Who cannot join
- Subject is part of a vulnerable population.
- Cannot consent for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: 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
Read more
Secondary Objective(s) -
- 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.
- Patient satisfaction using PGIC from one week to 6-months post procedure
- 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.
Read the 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.
- 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.
- 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) -
- 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.
- Patient satisfaction using PGIC from one week to 6-months post procedure
- 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
- Conditions
- Pain, Chronic, Lumbar Radiculopathy, SCS
- Keywords
- Spinal Cord Stimulator, Neuromonitoring, Lumbar radiculopathy, ELECTROMYOGRAPHY, Lumbar Pain, Muscle Action Potential, Intraoperative Neurophysiological Monitoring
- Medical subject headings
- Chronic Pain, Radiculopathy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SCS | Patients undergoing a spinal cord stimulator trial who is planning to have intraoperative neuromonitoring performed during the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Weeks
Secondary outcomes (2)
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.
Measured: 2 Weeks
Patient Global Impression of Change (PGIC)
Patient satisfaction using PGIC from baseline to 2 weeks post procedure
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start10 Dec 2022
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Why it stopped: lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdalena Anitescu, MD PHD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540756
- Sponsor's protocol ID
- IRB22-0275
- Acronym
- SCS-Monitor
- Status last verified
- Apr 2023
- First submitted
- 12 Sep 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Observational Pilot Study on the Use of Intraoperative Neurophysiological Monitoring in Spinal Cord Stimulator Trials
- ClinicalTrials.gov ID
- NCT05540756
- Acronym / sponsor ID
- SCS-Monitor / IRB22-0275
- Conditions
- Pain, Chronic, Lumbar Radiculopathy, SCS
- Keywords
- Spinal Cord Stimulator, Neuromonitoring, Lumbar radiculopathy, ELECTROMYOGRAPHY, Lumbar Pain, Muscle Action Potential, Intraoperative Neurophysiological Monitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) -
- 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.
- Patient satisfaction using PGIC from one week to 6-months post procedure
- 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.
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.
- 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.
- 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) -
- 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.
- Patient satisfaction using PGIC from one week to 6-months post procedure
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS | – | –Patients undergoing a spinal cord stimulator trial who is planning to have intraoperative neuromonitoring performed during the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a SCS trial as part of thier standard of care who are diagnosed with lumbar radiculopathy.
Key inclusion criteria (2 listed)
- Diagnosis of Lumbar Radiculopathy
- Expected to receive a Spinal Cord Stimulator trial at at the university of Chicago Medical Center
Key exclusion criteria (2 listed)
- Subject is part of a vulnerable population.
- Cannot consent for themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spinal Cord Stimulator (SCS) Coverage
Time frame: 2 Weeks
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 secondary outcomes
Numerical Rating Scale (NRS)
Time frame: 2 Weeks
Patient Global Impression of Change (PGIC)
Time frame: 2 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Anitescu, MD PHD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Lumbar Radiculopathy, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Stimulator (SCS) Coverage (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.