By InvitationNot Applicable

Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery

United States500 participantsStarted 2020-05-01

Plain-language summary

Intraoperative Neuromonitoring (IONM) is a tool used by neurophysiologists during spine surgery to prevent irreversible damage to the spinal cord during procedures through a system of alerts. This study investigates the effectiveness of IONM in 300 participants receiving spine surgery. The goal of this study is to refine the alert criteria for procedures in which IONM is used.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must be 18+ years old * Patients must be undergoing cervical and/or thoracic spine surgical procedure at Abbott Northwestern Hospital in Minneapolis, MN Exclusion Criteria: * Patients who are non-English speakers * Patients with ongoing psychiatric concerns are excluded * Patients unwilling to be contacted for a 6-month follow-up

What they're measuring

Nature of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions

Timeframe: 1 day

Nature of changes in free-run smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulation and recording.

Timeframe: 1 day

The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.

Timeframe: 1 day

Trial details

NCT IDNCT05110833

SponsorAllina Health System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04

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