Acute Concussion Management in Emergency Medicine with 7T MRI: a Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 7T MRI brain.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury (TBI); Concussion, Initial Encounter. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to learn about the brain imaging changes associated with concussion using a very detailed (7T) MRI scanner. To do this, the investigators will study 7T MRI brain imaging in patients aged 18-40 who present to the Emergency Department within 96 hours of a head injury. Patients will be eligible if they have had a normal CT brain as part of their usual care. The investigators will compare brain imaging from patients who have completely recovered from an episode of concussion to patients who still have significant symptoms at approximately 28 days after a head injury. The study attempts to answer the following questions: 1. Do patients with ongoing symptoms after concussion show greater 7T MRI brain imaging evidence of changes to the blood vessels at approximately 28 days after their injury in comparison to patients who have recovered fully? 2. Do patients with ongoing symptoms after concussion show greater 7T MRI brain imaging evidence of changes in brain signaling pathways at approximately 28 days after their injury, in comparison to patients who have recovered fully?
Detailed description
Evaluation of symptoms will be conducted at presentation in the Emergency Department and at 25 +/- 3 days after head injury. This will be assessed using 2 validated questionnaires: the Neurological Assessment Questionnaire (NAQ) and the Post Concussion Symptom Scale (PCSS).
Lifetime incidence of concussion will be assessed at 7T MRI using the a modified version of the Brain Injury Screening Questionnaire (BISQ).
Information will also be collected regarding painkiller use, anticoagulation, return to work, and any related further unscheduled care admissions or CT head imaging.
Interventions
- Diagnostic test 7T MRI brain
A very detailed MRI scan of the brain using a 7T MRI scanner.
Primary outcome measures
- Microvascular Pathology (Blood Vessel Changes) on 7T MRI brain [Time frame: 28 +/- 14 days from head injury]
Secondary outcome measures (1)
- Changes in Brain Signalling Pathways on 7T MRI [Time frame: At 28 +/- 14 days from head injury]
Eligibility criteria
Inclusion criteria
- Isolated head trauma
- Initial review within 96h of injury
- No acute findings on CT head
- Aged 18-40 years
Exclusion criteria
- Patient unable to give informed consent
- Patient unable to speak and understand English
- Patients where alternative diagnosis cannot be excluded
- Polytrauma
- Contra-indication to MRI
- BMI >40 or unable to comfortably lie on MRI scanner
- Pregnant
- Major confounding neurological disease e.g Multiple sclerosis, Stroke, Parkinson's Disease.
- Patient participation in other research studies concurrently
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06830616 · INGN24HS153