Long-Term Outcomes Following HBOT
NCT07732374
Behavior, Brain Concussion
Boise, Idaho, United States
View Trial DetailsNCT Number: NCT06454591
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
University of Calgary, Calgary, Alberta, Canada
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Sub-acute MRI study
Inclusion criteria
Exclusion criteria
Focus group study Individuals with chronic TBI
Inclusion criteria
Exclusion criteria
Caregivers of individuals with chronic TBI
Inclusion criteria
Exclusion criteria
Clinicians who treat TBI
Inclusion criteria
Exclusion criteria
-N/A
Inclusion criteria
Exclusion criteria
-N/A
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
Contact information is provided by the study sponsor or research team.
D.J Cook
Other
Developing a Rapid Objective Functional MRI Assessment and Report to Characterize Functional Abilities and Predict Persistent Symptoms Following Traumatic Brain Injury
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