Recruiting

Observational Study

Sponsor:

D.J Cook

Code:

NCT06454591

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06454591

Start date

Nov, 2024

Status verified date

Oct, 2024

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

TBI patients

Individuals with chronic TBI

Caregivers of individuals with chronic TBI

Clinicians who treat individuals with TBI

Legal and insurance personnel

Primary outcome measure

  • Model performance for prediction of post-concussion symptom scale (PCSS) score [ Time Frame: Model predicts 90-day PCSS score ]

Central Contacts and Locations

Central contacts

Douglas J Cook, MD, PhD

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

Chantel Debert, MD, MSc

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

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N1N4

Contacts

Chantel Debert

4032205110cdebert@ucalgary.ca

Queen's University

Recruiting

Kingston, Ontario, Canada, K7L3N6

Contacts

DJ Cook

61354966666dj.cook@queensu.ca

More Information

Sponsor

D.J Cook

Last update posted

Oct 18, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by D.J Cook on 2024-10-18.