← Back to Search

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

No Placebo-Only Group

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and time-point 1: 7 months post-injury and time-point 2: 12 months post-injury for reporting.

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 more

Secondary study objectives

Gliosis and inflammation biomarker predictors in serum samples

Tumor Markers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met