Pulse-Width Modulation Study for Spinal Fusion and Stenosis

This study is looking at a new way to check the placement of screws during spinal fusion surgery. Researchers will use "pulse-width modulation" (a way to change electrical signals) to stimulate the pedicle screws (screws placed in the spine) with three different settings: 0.4 milliseconds, 0.2 milliseconds, and 0.05 milliseconds. The goal is to see how these different settings affect the body's response, specifically the CMAP (Compound Muscle Action Potential, a measure of nerve activity). You might be able to join if you are 18 or older, having surgery that involves pedicle screw placement, and will have your nerves monitored during the operation. This study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to include 50 participants.
What's involved
You would have the pedicle screws stimulated with different pulse-width settings during your surgery, after the screws are placed.
Compensation
Not stated in the trial record.
Follow-up
The main measurement (CMAP response) is taken within the operating room, on the day of surgery.

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NCT06120231

Pulse-Width Modulation

Recruiting
NAAges 18+Interventional
Dartmouth-Hitchcock Medical Center
~50 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Pulse width modulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CMAP response under three different pulse-width settings
Measured over Within operating room upon completion of pedicle screw placement. 1 day
Spinal Fusion
Spinal Stenosis
1 sites across 1 states
New Hampshire1
  • Linton Evans, Dr. · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

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Eligibility criteria

Inclusion

A patient will be eligible for study participation once they have been booked for a surgery involving pedicle screw placement and intraoperative neuromonitoring.

Exclusion

The study excludes neonates, minors, pregnant women, prisoners and cognitively impaired patients.
  • CMAP response under three different pulse-width settingsWithin 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).