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NCT Number: NCT06120231

Pulse-Width Modulation

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.

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Key information

Conditions

Spinal Fusion Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Health

Lebanon, New Hampshire, 03677, United States

Location status: Recruiting

Location contact

Beverly Allen, BS

CONTACT

[email protected]

603-653-9021

Linton Evans, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulse width modulation

Diagnostic Test

Will be stimulating the pedicle screws utilizing three different pulse-width settings, 0.4 milliseconds, 0.2 milliseconds, and 0.05 milliseconds.

Primary outcomes

  1. CMAP response under three different pulse-width settings

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Sinks, MPH

CONTACT

[email protected]

6036179909

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Pulse-width Modulation During Pedicle Screw Stimulation

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 7, 2023
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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