Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes

May 20, 2022 updated by: Jonathan Norton, University of Saskatchewan
Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression.

Study Overview

Status

Completed

Conditions

Detailed Description

Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression. Tests will include the pre and post decompression MEP (motor evoked potential) latency and pre and post surgery walking speed and quality of life assessments.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with central spinal stenosis scheduled for surgical decompression.

Description

Inclusion Criteria:

  • Central spinal stenosis
  • Ability to ambulate prior to onset of symptoms

Exclusion Criteria:

  • Arthritis affecting walking ability (hip, knee or ankle).
  • Diabetes
  • Implanted pacemaker or other electrostimulator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Surgery Group
Consecutive patients from a two surgeon practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Evoked Potential Latency
Time Frame: Day 0
MEP latency at induction and completion of decompression
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 m Timed Walking speed
Time Frame: pre-surgery and 3 months post surgery
10m timed walk
pre-surgery and 3 months post surgery
Quality of Life measured in SF-36
Time Frame: pre-surgery and 3 months post surgery
SF-36
pre-surgery and 3 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: Jonathan Norton, PhD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

October 1, 2021

Study Completion (ACTUAL)

May 1, 2022

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (ESTIMATE)

August 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Norton15_05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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