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

NCT05110833 | Enrolling By Invitation

• 1 other identifier: 1557758
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Spinal Curvatures; Spinal Stenosis; Spondylitis; Spondylosis

Keywords

IONM

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Short Form (36) Health Survey

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Anyone 18 or older of any sex undergoing cervical and/or thoracic spine surgical proceudre with intraoperative neuromonitoring at Abbott Northwestern Hospital in Minneapolis, MN

You may qualify if:

• Must be 18+ years old
• Patients must be undergoing cervical and/or thoracic spine surgical procedure at Abbott Northwestern Hospital in Minneapolis, MN

You may not qualify if:

• Patients who are non-English speakers
• Patients with ongoing psychiatric concerns are excluded
• Patients unwilling to be contacted for a 6-month follow-up

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55447, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Spinal Curvatures; Spinal Stenosis; Spondylitis; Spondylosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bone Diseases, Infectious; Infections

Study Officials

• Stanley A Skinner, MD

  Allina Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: November 8, 2021
• Study Start: May 1, 2020
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)