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Traumatic Brain InjuryNCT06454591

Rapid MRI for Assessing Functional Abilities and Predicting TBI Outcomes

An observational study of Traumatic Brain Injury, run by D.J Cook at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
How many people
300 participants
Where
2 sitesCanada
Study dates
Nov 2024to Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Diagnosis of TBI
  • Diagnosis of TBI greater than one year prior
  • Relation who was diagnosed with TBI greater than one year prior that individual was the primary caregiver for
  • 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
  • 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

Who cannot join

  • 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
  • Major neurologic, psychiatric or substance use disorder
Show all 11Show fewer
  • Caregivers of individuals with chronic TBI
  • Major neurologic, psychiatric or substance use disorder
  • Clinicians who treat TBI
  • -N/A
  • -N/A

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Douglas J Cook, MD, PhD contact

1-613-549-6666 ext. 3696

dj.cook@queensu.ca

Chantel Debert, MD, MSc contact

1-403-944-4224

cdebert@ucalgary.ca

Canada2 sites, 2 recruiting
  • University of Calgary

    Calgary, Alberta, T2N1N4

    Chantel Debert, 4032205110, cdebert@ucalgary.ca

    Recruiting
  • Queen's University

    Kingston, Ontario, K7L3N6

    DJ Cook, 61354966666 ext. 3696, dj.cook@queensu.ca

    Recruiting

Other trials in Canada

About this study

Official title: Developing a Rapid Objective Functional MRI Assessment and Report to Characterize Functional Abilities and Predict Persistent Symptoms Following Traumatic Brain Injury

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.

Read the detailed description

Traumatic brain injury (TBI) can range from mild (mTBI) to moderate and severe (msTBI), and 69 million individuals worldwide sustain a TBI annually. There are many unanswered questions related to the diagnosis of TBI, the prediction of recovery, and the selection of effective treatments. For a subset of patients with TBI, persistent symptoms (PS) can substantially reduce quality of life. Particularly for mTBI, these impairments occur frequently without evidence of structural damage to the brain on MRI or CT. The lack of objective evidence of damage can limit a patient's access to clinical resources, insurance coverage and compensation related to their injury.

Furthermore, clinicians often have difficulty predicting TBI patients' course and extent of recovery. Preliminary evidence suggests that combining several novel types of MRI techniques may enable the detection of changes in individuals with TBI and provide information about patient recovery. Therefore, our proposed research project will assess individuals with TBI using novel MRI and a battery of assessments that examine how they function (functional assessments) in the acute stages after injury with a complete reassessment of function three months after injury. These procedures will be performed in 200 patients. Overall, this project will incorporate TBI survivors, family members/caregivers, clinicians, and members of the legal/insurance community to address four goals:

  1. To develop reports for survivors and their supporters to communicate MRI and functional assessment findings. This report will help survivors understand their injuries and symptoms and suggest treatments. Additionally, a more technical report will be developed for clinicians and legal/insurance personnel to support diagnosis, direct testing, and aid in choosing therapeutic approaches. Focus groups will be conducted for each group to develop the report content and format.
  2. To link MRI findings to neurological function and symptoms. The use of several MRI sequences increases our ability to identify deficits. However, this large amount of information may be difficult for a clinician to review, synthesize and use to predict patient function. The investigators developed a method to summarize the MRI data into intuitive outputs to address this. These outputs are linked to function and allow clinicians and patients to connect the damage detected by MRI to impairments in function.
  3. To develop a tool to assess the risk of PS 90 days after injury using MRI and clinical data collected early after injury.
  4. To develop a comprehensive MRI protocol that can be performed within the shortest possible time on any clinical MRI scanner to make this testing widely accessible. For the complete MRI protocol used in this study, the total time will be 45 minutes, with five types of MRI collected. The investigators will perform analyses where one or more MRI types is removed from the analysis to understand whether all types collected are necessary to achieve the outcome. This will allow us to reduce the scan time as the clinical protocol is developed.

Findings from this work will be impactful for the following reasons: (1) the development of a report will allow patients and caregivers to be more informed about their path to recovery; (2) the development of an accessible clinical protocol and report will allow clinicians to access functional neuroimaging; (3) a protocol that links functional neuroimaging changes to functional impairment will provide evidence that injury is linked to signs/symptoms in TBI; (4) identification of patients at risk for PS combined with a comprehensive functional evaluation in the acute stages of injury will allow clinicians to focus on early therapy to prevent PS; and (5) development of the shortest possible protocol for data acquisition that increases patient comfort and increases accessibility to functional neuroimaging in the clinical setting.

Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06454591
Study groupRoleWhat they receive
TBI patientsNot described
Individuals with chronic TBINot described
Caregivers of individuals with chronic TBINot described
Clinicians who treat individuals with TBINot described
Legal and insurance personnelNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Model predicts 90-day PCSS score

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study startNov 2024 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06454591
Sponsor's protocol ID
6041393
Status last verified
Oct 2024
First submitted
6 Jun 2024
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury, run by D.J Cook at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Douglas J Cook, MD, PhD (1-613-549-6666 ext. 3696, dj.cook@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Model performance for prediction of post-concussion symptom scale (PCSS) score (time frame: Model predicts 90-day PCSS score). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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