Online memory intervention for people with traumatic brain injury
Remotely Delivered Environmental Enrichment Intervention for Traumatic Brain Injury: a Randomized Controlled Trial
This study tests whether an online memory training program can help people with moderate to severe traumatic brain injury improve their memory and brain health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Toronto Rehabilitation Institute Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04331392 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and feasibility of an online spatial navigation intervention aimed at improving memory and brain health in individuals with moderate to severe traumatic brain injury. Participants will engage in a structured program that involves learning new routes and creating mental maps for one hour a day, five days a week over 16 weeks. The study will compare outcomes between those participating in the intervention and an active control group watching educational videos. Assessments will include MRI scans and cognitive measures focused on memory and spatial navigation before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 who have sustained a moderate to severe traumatic brain injury and have the ability to engage with computer-based interventions.
Not a fit: Patients with neurological disorders other than TBI, systemic comorbidities, or those ineligible for MRI due to metal implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance memory function and brain health in individuals recovering from traumatic brain injuries.
How similar studies have performed: While the approach is innovative, similar studies focusing on cognitive rehabilitation in TBI have shown promising results, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * acute care diagnosis of m-sTBI * PTA of 24 hours or more and/or lowest GCS \<13 * positive CT or MRI; (4) between 18 to 55 years of age * fluency in English; (6) competency to provide informed consent or availability of a legal decision maker * basic computer skills (use of internet/email, mouse and arrow keys) * functional use of at least one upper extremity for computer use * resident of Greater Toronto Area (to facilitate access to the MRI). Exclusion Criteria: * neurological disorder other than TBI (e.g., dementia, stroke) * diagnosis of a neurodevelopmental disorder * TBI sustained before age 18 * systemic comorbidities (e.g., lupus, diabetes) * current diagnosis of aphasia * presence of metal inside the body (e.g., surgical clips, pacemaker) leading to ineligibility for an MRI.
Where this trial is running
Toronto, Ontario
- Toronto Rehabilitation Institute — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Robin E Green, PhD; CPsych — Toronto Rehabilitation Institute
- Study coordinator: Kadeen Johns, BA
- Email: kadeen.johns@uhn.ca
- Phone: 416-597-3422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.