Pulse-Width Modulation
Part of paid clinical trials in Lebanon, New Hampshire.
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Study ID
- NCT06120231
- Status
- Recruiting
Conditions
- Spinal Fusion
- Spinal Stenosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pulse width modulation — DIAGNOSTIC_TESTWill be stimulating the pedicle screws utilizing three different pulse-width settings, 0.4 milliseconds, 0.2 milliseconds, and 0.05 milliseconds.
Study Details
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.
Key Dates
- Start date
- Dec 1, 2023
- Status verified
- Mar 2025
- Primary completion
- Jun 1, 2026
- Completion
- Jun 1, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Pedicle Screw Stimulation Arm
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
- Beverly Allen, BS6036179909
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dartmouth-Health | Lebanon | New Hampshire | 03677 | Linton Evans, MD (PRINCIPAL_INVESTIGATOR) |
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