NCT03892356

Brief Summary

This is a prospective longitudinal study which aims to compare oculomotor function and visual scanning behaviour (VSB) of participants who suffered concussion with healthy controls with no concussion. This study also aims to investigate the pattern of change in oculomotor function and visual scanning behaviour (VSB) in the participants over a 6-month period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

2.1 years

First QC Date

March 21, 2019

Last Update Submit

September 24, 2019

Conditions

Keywords

Concussion, Oculomotor function

Outcome Measures

Primary Outcomes (1)

  • self-paced saccade

    Number of self paced saccadic eye movements in 60 seconds

    2 years

Study Arms (2)

Concussion Group

Participants (age group 18-60) who presents to the emergency department in the University Health Network within 7 days of concussion

Healthy Controls Group

Participants (age group 18-60) with no previous history of concussions who are age, education and sex-matched to the patients' group will be recruited from the community.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

100 participants who suffered concussions and present to the emergency department in the University Health Network within 7 days of concussion will be compared with 20 healthy volunteers who have no history of concussions.

You may qualify if:

  • Participants (age group 18-60) who present to the emergency department in the University Health Network within 7 days of concussion

You may not qualify if:

  • Age less than 18
  • Any other neurological disorder (e.g. seizures)
  • Any systemic illness known to affect the brain (e.g. diabetes and lupus)
  • History of major psychiatric disorder (e.g. bipolar, schizophrenia)
  • History of known developmental disorders (e.g. attention deficit disorder, dyslexia)
  • Any lesion detected by MRI prior to the study
  • Any previous vision disorder that prevents the participant from performing the self-paced saccade task
  • Any brain injury more severe than concussion
  • Controls:
  • Participants (age group 18-60) with no previous history of concussions who are age, education and sex-matched to the patients' group will be recruited from the community.
  • Healthy Controls:
  • Participants (age group 18-60) with no previous history of concussions who are age, education and sex-matched to the patients' group will be recruited from the community.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canadian Concussion Centre, Toronto Western Hospital, University Health Network

Toronto, Ontario, M6J 3S3, Canada

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Central Study Contacts

Mozhgan Khodadadi, MA

CONTACT

Carmela Tartaglia, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marion and Gerald Soloway Chair in Brain Injury and Concussion Research Associate Professor, University of Toronto

Study Record Dates

First Submitted

March 21, 2019

First Posted

March 27, 2019

Study Start

March 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations