Spinal Fusion, Spinal Stenosis
Conditions
Brief summary
The overarching aim of this project is to modulate the pulse-width during stimulation of pedicle screws and record the response thresholds associated with each PWM setting. During this initial phase of the investigation, no further data will be collected.
Detailed description
In vivo electrical stimulation of pedicle screws is a well-documented modality for evaluating potential breach of the pedicle wall. However, previous research has focused primarily on the stimulation threshold intensity required to elicit a neurophysiological response. Other stimulation parameters, such as pulse-width, remain uninvestigated. The goal is to obtain data on the pulse-width vs. CMAP relationship.
Interventions
DIAGNOSTIC_TESTPulse width modulation
Will be stimulating the pedicle screws utilizing three different pulse-width settings, 0.4 milliseconds, 0.2 milliseconds, and 0.05 milliseconds.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A patient will be eligible for study participation once they have been booked for a surgery involving pedicle screw placement and intraoperative neuromonitoring.
Exclusion criteria
* The study excludes neonates, minors, pregnant women, prisoners and cognitively impaired patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMAP response under three different pulse-width settings | Within operating room upon completion of pedicle screw placement. 1 day | Upon completion of the pedicle screw placements, each screw will be stimulated utilizing three different pulse-width settings, 0.4 milliseconds, 0.2 milliseconds, and 0.05 milliseconds. The stimulation intensity required to elicit a compound muscle action potential (CMAP) will be recorded for each pulse-width parameter. This is measured in microvolts (uV). |
Countries
United States
Contacts
CONTACTLauren Sinks, MPH
PRINCIPAL_INVESTIGATORLinton Evans, Dr.
Dartmouth-Hitchcock Medical Center
Outcome results
None listed