Pulse-Width Modulation

Spinal Stenosis Clinical Trial

Official title:

Pulse-width Modulation During Pedicle Screw Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120231
• Other study ID #: STUDY02001964
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: January 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Beverly Allen, BS
• Phone: 6036179909
• Email: Beverly..A.Allen[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Fusion
• Spinal Stenosis

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Health	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMAP response under three different pulse-width settings	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).	Within operating room upon completion of pedicle screw placement. 1 day