Recruiting

Observational Study

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06120231

Conditions

Spinal Fusion

Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulse width modulation

Study Details

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.

Conditions

Spinal Fusion

Spinal Stenosis

Study ID

NCT06120231

Start date

Dec 1, 2023

Status verified date

Jul, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Jun 1, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Pedicle Screw Stimulation Arm

Interventions

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.

Primary outcome measure

  • CMAP response under three different pulse-width settings [ Time Frame: Within operating room upon completion of pedicle screw placement. 1 day ]

Central Contacts and Locations

Central contacts

Lauren Sinks, MPH

6036179909Lauren.J.Sinks@hitchcock.org

Locations

Dartmouth-Health

Recruiting

Lebanon, New Hampshire, United States, 03677

Contacts

Beverly Allen, BS

603-653-9021Beverly.A.Allen@hitchcock.org

Principal Investigator:

Linton Evans, MD

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-07-09.