Spinal Stenosis Clinical Trial
— IONMOfficial title:
Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery
Verified date | February 2024 |
Source | Allina Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 500 |
Est. completion date | April 2026 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Allina Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nature of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions | Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuation in amplitude and/or frequency, will be recorded. | 1 day | |
Primary | Nature of changes in free-run smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulation and recording. | Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuation in amplitude and/or frequency, will be recorded. | 1 day | |
Primary | The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations. | 1 day | ||
Secondary | Short Form (36) Health Survey | A self-report survey of patient health | 1 year |
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