Pulse-Width Modulation

Dartmouth Health

Status: Enrolling

Conditions: Spinal Stenosis; Spinal Fusion

Treatments: Diagnostic Test: Pulse width modulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06120231

STUDY02001964

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Pedicle Screw Stimulation Arm

Experimental group

Treatment:

Diagnostic Test: Pulse width modulation