Acute Concussion Management in Emergency Medicine with 7T MRI: a Feasibility Study

ConditionTraumatic Brain Injury (TBI); Concussion, Initial Encounter

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-40

SponsorNHS Greater Glasgow and Clyde

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Isolated head trauma

Initial review within 96h of injury

No acute findings on CT head

Aged 18-40 years

Disqualifiers

Patient unable to give informed consent

Patient unable to speak and understand English

Patients where alternative diagnosis cannot be excluded

Polytrauma

Trial population

Patients will be recruited from the Emergency Department at the Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

7T MRI brain
Diagnostic test
A very detailed MRI scan of the brain using a 7T MRI scanner.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Patients who have completely recovered from concussion1 intervention

Group B: Patients who have ongoing symptoms from concussion1 intervention

Trial outcomes

Primary outcomes

Microvascular Pathology (Blood Vessel Changes) on 7T MRI brain

To explore whether patients with ongoing symptoms after a concussion show greater 7T MRI brain imaging evidence of microvascular pathology (blood vessel changes) at 28 (± 14) days after their injury in comparison to patients who have recovered fully.

Time frame

28 +/- 14 days from head injury

Secondary outcomes

Changes in Brain Signalling Pathways on 7T MRI

To explore whether patients with ongoing symptoms after concussion show greater 7T MRI brain imaging evidence of ongoing metabolic disturbance in brain signalling pathways at 28 (± 14) days after their injury, in comparison to patients who have recovered fully.

Time frame

At 28 +/- 14 days from head injury

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: