Rapid MRI for Assessing Functional Abilities and Predicting TBI Outcomes

October 16, 2024 updated by: D.J Cook

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Douglas J Cook, MD, PhD
  • Phone Number: 3696 1-613-549-6666
  • Email: dj.cook@queensu.ca

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N1N4
        • Recruiting
        • University of Calgary
        • Contact:
    • Ontario
      • Kingston, Ontario, Canada, K7L3N6
        • Recruiting
        • Queen's University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
TBI patients
Individuals with chronic TBI
Caregivers of individuals with chronic TBI
Clinicians who treat individuals with TBI
Legal and insurance personnel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Model performance for prediction of post-concussion symptom scale (PCSS) score
Time Frame: Model predicts 90-day 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
D.J Cook

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Calgary

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Douglas J Cook, MD, PhD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6041393

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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