Pulse-Width Modulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A patient will be eligible for study participation once they have been booked for a surgery involving pedicle screw placement and intraoperative neuromonitoring.
Disqualifiers
The study excludes neonates, minors, pregnant women, prisoners and cognitively impaired patients.
Trial design
Design model
Single group
Treatments tested in this trial
Pulse width modulation
Diagnostic testWill be stimulating the pedicle screws utilizing three different pulse-width settings, 0.4 milliseconds, 0.2 milliseconds, and 0.05 milliseconds.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Pedicle Screw Stimulation ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CMAP response under three different pulse-width settings
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).
Time frame
Within operating room upon completion of pedicle screw placement. 1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov