NCT06120231

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Dec 2023Jun 2027

First Submitted

Initial submission to the registry

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 5, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

November 1, 2023

Last Update Submit

June 3, 2025

Conditions

Spinal FusionSpinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Pedicle Screw Stimulation Arm

EXPERIMENTAL
Diagnostic Test: Pulse width modulation

Interventions

Pulse width modulationDIAGNOSTIC_TEST

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

Pedicle Screw Stimulation Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A patient will be eligible for study participation once they have been booked for a surgery involving pedicle screw placement and intraoperative neuromonitoring.

You may not qualify if:

  • The study excludes neonates, minors, pregnant women, prisoners and cognitively impaired patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Health

Lebanon, New Hampshire, 03677, United States

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Linton Evans, Dr.

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beverly Allen, BS

CONTACT

6036179909Beverly..A.Allen@hitchcock.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Linton Evans

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

June 5, 2025

Record last verified: 2025-03

Locations

US(1)