Pulse-Width Modulation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06120231
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dartmouth-Hitchcock Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Linton Evans, Dr.
Principal Investigator Affiliation	Dartmouth-Hitchcock Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Fusion, Spinal Stenosis

Additional Details

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.#46; CMAP relationship.

Arms & Interventions

Arms

Experimental: Pedicle Screw Stimulation Arm

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dartmouth-Health, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Health

Lebanon, New Hampshire, 03677

Site Contact

Beverly Allen, BS

[email protected]

603-653-9021

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