Changes in Motor Latency During Spinal Decompression: Rel... | NCT02529943

Studies
Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes

NCT02529943

Sponsor

University of Saskatchewan

Status

Completed

Last Update Posted

May 24, 2022Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Spinal Stenosis

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Oct 2021Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Aug 13, 2015

First Submission Date that Met QC Criteria

Aug 19, 2015

First Posted Date

Aug 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2022

Last Update Posted Date

May 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
Surgery Group		Consecutive patients from a two surgeon practice

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients with central spinal stenosis scheduled for surgical decompression.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan Norton, PhD	University of Saskatchewan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal University Hospital		Saskatoon	Saskatchewan	S7N 0W8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D013130	Spinal Stenosis

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided