NCT02529943

Brief Summary

Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

5.4 years

First QC Date

August 13, 2015

Last Update Submit

May 20, 2022

Conditions

Spinal Stenosis

Keywords

Spinal StenosisMotor Evoked Potential

Outcome Measures

Primary Outcomes (1)

  • Motor Evoked Potential Latency

    MEP latency at induction and completion of decompression

    Day 0

Secondary Outcomes (2)

  • 10 m Timed Walking speed

    pre-surgery and 3 months post surgery

  • Quality of Life measured in SF-36

    pre-surgery and 3 months post surgery

Study Arms (1)

Surgery Group

Consecutive patients from a two surgeon practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with central spinal stenosis scheduled for surgical decompression.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Jonathan Norton, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 20, 2015

Study Start

May 1, 2016

Primary Completion

October 1, 2021

Study Completion

May 1, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations

CA(1)