Spinal StenosisNCT02529943
Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes
An observational study of Spinal Stenosis, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with central spinal stenosis scheduled for surgical decompression.
Who may be able to join
- Central spinal stenosis
- Ability to ambulate prior to onset of symptoms
Who cannot join
- Arthritis affecting walking ability (hip, knee or ankle).
- Diabetes
- Implanted pacemaker or other electrostimulator.
Trial locations and contacts
1 site in 1 country.
About this study
Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression.
Read the 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.
- Conditions
- Spinal Stenosis
- Keywords
- Spinal Stenosis, Motor Evoked Potential
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Group | Consecutive patients from a two surgeon practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Evoked Potential Latency
MEP latency at induction and completion of decompression
Measured: Day 0
Secondary outcomes (2)
10 m Timed Walking speed
10m timed walk
Measured: pre-surgery and 3 months post surgery
Quality of Life measured in SF-36
SF-36
Measured: pre-surgery and 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startMay 2016
- Primary completionOct 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Norton, University of Saskatchewan
- Investigators
- Jonathan Norton, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529943
- Sponsor's protocol ID
- Norton15_05
- Status last verified
- May 2022
- First submitted
- 13 Aug 2015
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes
- ClinicalTrials.gov ID
- NCT02529943
- Acronym / sponsor ID
- Norton15_05
- Conditions
- Spinal Stenosis
- Keywords
- Spinal Stenosis, Motor Evoked Potential
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery Group | – | –Consecutive patients from a two surgeon practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with central spinal stenosis scheduled for surgical decompression.
Key inclusion criteria (2 listed)
- Central spinal stenosis
- Ability to ambulate prior to onset of symptoms
Key exclusion criteria (3 listed)
- Arthritis affecting walking ability (hip, knee or ankle).
- Diabetes
- Implanted pacemaker or other electrostimulator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor Evoked Potential Latency
Time frame: Day 0
MEP latency at induction and completion of decompression
2 secondary outcomes
10 m Timed Walking speed
Time frame: pre-surgery and 3 months post surgery
Quality of Life measured in SF-36
Time frame: pre-surgery and 3 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Norton, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Evoked Potential Latency (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.