Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05540756 |
| Other study ID # |
IRB22-0275 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 10, 2022 |
| Est. completion date |
December 10, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
University of Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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
