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Behavioral Intervention
Online Spatial Navigation Training for Traumatic Brain Injury (m-sTBI Trial)
N/A
Recruiting
Led By William Panenka, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have functional use of one upper extremity
An acute care diagnosis of TBI as determined by a medical professional, indicated by: Post-traumatic amnesia duration of 24 hours or more, and/or lowest Glasgow Coma Scale score of < 13
Must not have
Experiencing language impairments (i.e., aphasia) from the injury
A neurological disorder other than TBI impairing baseline awareness, cognition, or validity of follow-up and outcome assessment (e.g., stroke, dementia, tumor, neurodevelopmental disorder)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time-point 1: 7 months post-injury and time-point 2: 12 months post-injury
Awards & highlights
Summary
This trial will help researchers understand if it's possible to improve memory in patients with m-sTBI, and what effect the intervention has on the brain.
Who is the study for?
This trial is for adults aged 18-65 who've had a moderate or severe traumatic brain injury (m-sTBI), confirmed by CT or MRI scans. Participants must speak English, be able to give informed consent, have basic computer skills and internet access, and can use one upper extremity. Those with MRI contraindications, other neurological disorders, systemic conditions like diabetes or language impairments from the injury cannot join.
What is being tested?
The study tests an online spatial navigation training program aimed at improving memory in patients with m-sTBI. It will also assess how this intervention affects brain structures related to memory and cognitive function.
What are the potential side effects?
Since the intervention involves non-invasive online training exercises, no direct physical side effects are expected from participating in this clinical trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can use one of my arms or hands.
Select...
I have been diagnosed with a severe brain injury.
Select...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have trouble speaking or understanding language due to an injury.
Select...
I do not have any neurological conditions affecting my awareness or thinking, other than TBI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time-point 1: 7 months post-injury and time-point 2: 12 months post-injury
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time-point 1: 7 months post-injury and time-point 2: 12 months post-injury
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Online Spatial Navigation Intervention Test Scores: Change in Cognitive Map Formation
Online Spatial Navigation Intervention Test Scores: Change in Pattern Completion
Online Spatial Navigation Intervention Test Scores: Change in Pattern Separation
+1 moreSecondary study objectives
Gliosis and inflammation biomarker predictors in serum samples
Tumor Markers
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
For the treatment arm, the participants will complete the intervention protocol following the first in-person study visit 7 months post-injury. The intervention involves 16 weeks of online, in-home spatial navigation training. During the 16 weeks, the participant will complete exercises for 1 hour/day, 5 days a week.
Group II: ControlActive Control1 Intervention
The control arm participants will receive their typical standard of care; they will not complete the intervention but will complete all of the in-person visits at the same post-injury time-points as the treatment group.
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,165 Total Patients Enrolled
University Health Network, TorontoOTHER
1,514 Previous Clinical Trials
500,180 Total Patients Enrolled
William Panenka, MDPrincipal InvestigatorUniversity of British Columbia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can use one of my arms or hands.I can make my own medical decisions within 6 months after my injury.I have been diagnosed with a severe brain injury.I do not have a condition like lupus, diabetes, or arthritis affecting my awareness or thinking.I am between 18 and 65 years old.I have trouble speaking or understanding language due to an injury.I do not have any neurological conditions affecting my awareness or thinking, other than TBI.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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