Acute Concussion Management in Emergency Medicine with 7T MRI: a Feasibility Study (ACME-7T)
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:
- 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?
- 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?
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Prof Stewart
- Phone Number: (0141) 354 9535
- Email: william.stewart@glasgow.ac.uk
Study Contact Backup
- Name: Prof Lowe
- Phone Number: (0141) 452 2932
- Email: david.lowe@glasgow.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients who have completely recovered from concussion
Recovery from concussion will be assessed at 25 +/- 3 days using a validated symptom score, the Post Concussion Symptom Scale (PCSS).
This group will have a PCSS = 0.
|
A very detailed MRI scan of the brain using a 7T MRI scanner.
|
|
Patients who have ongoing symptoms from concussion
Recovery from concussion will be assessed at 25 +/- 3 days using a validated symptom score, the Post Concussion Symptom Scale (PCSS).
This group will have a PCSS > 10.
|
A very detailed MRI scan of the brain using a 7T MRI scanner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microvascular Pathology (Blood Vessel Changes) on 7T MRI brain
Time Frame: 28 +/- 14 days from head injury
|
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.
|
28 +/- 14 days from head injury
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Brain Signalling Pathways on 7T MRI
Time Frame: At 28 +/- 14 days from head injury
|
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.
|
At 28 +/- 14 days from head injury
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INGN24HS153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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