Rapid MRI for Assessing Functional Abilities and Predicting TBI Outcomes

NCT06454591 | Recruiting

• 1 other identifier: 6041393
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Our project aims to develop a rapidly acquired and communicated MRI assessment and report that incorporates functional and structural imaging to convey information about functional neurological insults following traumatic brain injury (TBI) that are not typically visible on clinical imaging. Within this framework, there are two sub-studies. The first is a prospective study of patients with TBI who will have an MRI in the sub-acute period after their injury, followed by clinical assessments up to 90 days post-injury. A model will be developed to link MRI biomarkers to persistent symptoms of TBI. The second sub-study will use a focus group methodology to develop the report content and format with input from several groups of stakeholders.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Model performance for prediction of post-concussion symptom scale (PCSS) score

  R-squared and mean absolute error for model performance for mild TBI and moderate/severe TBI models

  Model predicts 90-day PCSS score

Study Arms (5)

TBI patients

Individuals with chronic TBI

Caregivers of individuals with chronic TBI

Clinicians who treat individuals with TBI

Legal and insurance personnel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sub-acute MRI study Individuals with mTBI within previous 7 days and individuals with moderate or severe TBI in previous 90 days Focus group study Individuals with chronic TBI Caregivers of individuals with chronic TBI Clinicians who treat TBI Legal and insurance personnel who handle TBI cases

You may qualify if:

• \- Diagnosis of TBI

You may not qualify if:

• 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
• \- Diagnosis of TBI greater than one year prior
• \- Major neurologic, psychiatric or substance use disorder
• Caregivers of individuals with chronic TBI
• \- Relation who was diagnosed with TBI greater than one year prior that individual was the primary caregiver for
• \- Major neurologic, psychiatric or substance use disorder
• Clinicians who treat TBI
• \- 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
• N/A
• \- 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
• N/A

Sponsors & Collaborators

• D.J Cook: lead
• University of Calgary: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N1N4, Canada

RECRUITING

Queen's University

Kingston, Ontario, K7L3N6, Canada

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Douglas J Cook, MD, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas J Cook, MD, PhD

CONTACT

1-613-549-6666; dj.cook@queensu.ca

Chantel Debert, MD, MSc

CONTACT

1-403-944-4224; cdebert@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CA (2)