Rapid MRI assessment for traumatic brain injury outcomes
Developing a Rapid Objective Functional MRI Assessment and Report to Characterize Functional Abilities and Predict Persistent Symptoms Following Traumatic Brain Injury
Queen's University · NCT06454591
This study is testing a fast MRI method to see if it can help doctors understand the brain injuries and recovery of people who have had a traumatic brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's University (other) |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT06454591 on ClinicalTrials.gov |
What this trial studies
This project aims to develop a quick MRI assessment that combines functional and structural imaging to provide insights into neurological impairments following traumatic brain injury (TBI). It includes two sub-studies: one that prospectively evaluates TBI patients with MRI in the sub-acute phase and follows their clinical assessments for up to 90 days, and another that gathers input from stakeholders to refine the report format and content. The goal is to link MRI biomarkers to persistent symptoms of TBI and improve understanding of recovery trajectories.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with TBI in the sub-acute phase or those with chronic TBI lasting over a year.
Not a fit: Patients with a history of major neurologic, psychiatric, or substance use disorders, or those unable to undergo MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the diagnosis and treatment of TBI, leading to better patient outcomes and quality of life.
How similar studies have performed: Preliminary evidence suggests that combining novel MRI techniques has shown promise in similar studies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Sub-acute MRI study Inclusion Criteria: \- Diagnosis of TBI Exclusion Criteria: * Self-reported history of brain surgery * Self-reported history of major neurologic, psychiatric or substance use disorder * Contraindications to MRI * Inability to follow-up at 30 and 90 days Focus group study Individuals with chronic TBI Inclusion Criteria: \- Diagnosis of TBI greater than one year prior Exclusion Criteria: \- Major neurologic, psychiatric or substance use disorder Caregivers of individuals with chronic TBI Inclusion Criteria: \- Relation who was diagnosed with TBI greater than one year prior that individual was the primary caregiver for Exclusion Criteria: \- Major neurologic, psychiatric or substance use disorder Clinicians who treat TBI Inclusion Criteria: \- Employment as a physician or allied health professional who has spent greater than 50% of their time treating TBI patients for at least two years of their career Exclusion Criteria: -N/A Inclusion Criteria: \- Employment as a personal injury lawyer or insurance adjuster who has spent greater than 50% of their time on TBI cases for at least two years of their career Exclusion Criteria: -N/A
Where this trial is running
Calgary, Alberta and 1 other locations
- University of Calgary — Calgary, Alberta, Canada (RECRUITING)
- Queen's University — Kingston, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Douglas J Cook, MD, PhD — Queen's University
- Study coordinator: Douglas J Cook, MD, PhD
- Email: dj.cook@queensu.ca
- Phone: 1-613-549-6666
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.
Conditions: Traumatic Brain Injury