Concussion, Brain Clinical Trial
Official title:
Oculomotor Function Testing in Patients Who Suffered Concussions
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.
Primary Objective
- To identify differences in oculomotor function and visual scanning behaviour (VSB)
between participant with and without acute concussion
- To investigate patterns of change and recovery in oculomotor function and VSB in
participants who suffered a concussion
Secondary Objective
• To investigate the association between the oculomotor function and concussion-related
symptoms
This is a prospective longitudinal study which aims to evaluate differences in oculomotor
function and visual scanning behaviour (VSB) between participants who suffered acute
concussion and 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.
Health information and concussion history: After obtaining informed consents, during the
first visit, participants will be asked about their health history such as past medical
history, medication history, substance use history, and family history. They will also be
asked about their concussion history which includes number of concussions in the past, any
comorbidity with the concussions, mechanism of injury, and any change in their levels of
consciousness at the time of concussion.
Self-reported outcomes: During each visit, participants will be asked on the presence or
absence of concussion-related symptoms and the extent to which these symptoms affect their
everyday functioning if present. The symptoms the participants will be questioned using the
Rivermead Post-concussive Symptom Questionnaire (RPQ) as a standardized assessment
(https://www.commondataelements.ninds.nih.gov/TBI.aspx#tab=Data_Standards) at each visit .
Oculomotor function testing and visual scanning behaviour (VSB): During each visit,
oculomotor data will be collected using Visual Attention Scanning Technology (VAST, EL-MAR
Inc.). VAST is a technology that was developed to support advanced eye-tracking research
application. Over the past 10 years the technology has been used in research studies in the
University of Toronto, and University Health Network hospitals. Participants will be seated
65 cm from the monitor, and their binocular gaze positions will be estimated 30 times/sec
with an accuracy of 0.5º in visual angle. Following a calibration procedure, the participants
will be instructed to look at a series of slides presented on the monitor, and their eye
positions will be recorded. The eye positions will be segmented into fixations that are
linked to the displayed images. Oculomotor functions testing includes testing self-paced
saccadic (SPS) eye movements, fixation, anti-saccadic eye movements. Visual scanning
behaviour (VSB) will be assessed using a set of images which require patients to look at the
images and match them according to the instruction at the beginning of each test.
Patients will be assessed at baseline (i.e. within 7 days of concussion) and three follow-up
(f/u) visits (i.e. 1, 3, and 6 months after concussion).
Healthy controls will be assessed at baseline and one follow-up visit (i.e. 6 months after
the baseline).
The entire assessment in each visit takes 30-45 minutes.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04109677 -
AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball
|
||
| Recruiting |
NCT04932278 -
The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
|
N/A | |
| Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
N/A | |
| Recruiting |
NCT05682677 -
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
|
N/A | |
| Recruiting |
NCT04992130 -
Sport Concussion Performance-Based Prevention Program
|
N/A | |
| Completed |
NCT05095012 -
RECOVER Clinical Pathway for Pediatric Concussion
|
N/A | |
| Recruiting |
NCT05886400 -
The Effects of Environmental Distractions on SCAT6 Outcomes
|
N/A | |
| Active, not recruiting |
NCT05400551 -
Craneofacial Injuries in Rink Hockey Athletes
|
||
| Recruiting |
NCT04121780 -
Growth Hormone Replacement Therapy for Retried Professional Football Players
|
Phase 2 | |
| Withdrawn |
NCT03575741 -
Postural Control in Children and Adolescents After Suffering From a Concussion
|
||
| Active, not recruiting |
NCT05471791 -
Development of a Concussion Management Platform for Children and Youth
|
N/A | |
| Completed |
NCT04730167 -
The Monaco Initiative for Concussion in Motorsport Pilots
|
||
| Completed |
NCT03478059 -
Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
|
N/A | |
| Recruiting |
NCT05685121 -
A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents
|
N/A | |
| Completed |
NCT04122274 -
Comparing and Interactive Concussion Education Platform to Current Education Standards
|
N/A | |
| Completed |
NCT04558346 -
Ghrelin (OXE--103) for Acute Concussion Management
|
Phase 2 | |
| Completed |
NCT04074486 -
Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
|
||
| Not yet recruiting |
NCT05562232 -
The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms
|
N/A | |
| Recruiting |
NCT05326555 -
Dynamic Vision Testing and Concussion Management Dream Team 65
|
||
| Completed |
NCT03671083 -
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
|