NCT06120231

Pulse-Width Modulation

Pulse-width Modulation During Pedicle Screw Stimulation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Fusion
• Spinal Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pulse width modulation	Will be stimulating the pedicle screws utilizing three different pulse-width settings, 0.4 milliseconds, 0.2 milliseconds, and 0.05 milliseconds.

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2023-11-07
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States