Pulse-Width Modulation

Not Applicable

Recruiting

• Conditions: Spinal Stenosis; Spinal Fusion
• Interventions: Diagnostic Test: Pulse width modulation

• Registration Number: NCT06120231
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Study Start: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2026-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pedicle Screw Stimulation Arm	Pulse width modulation	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Dartmouth-Health; 🇺🇸 Lebanon, New Hampshire, United States