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:

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury (TBI); Concussion, Initial Encounter
• Intervention / Treatment: Diagnostic test: 7T MRI brain

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: Observational
• Enrollment (Estimated): 20

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: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Isolated head trauma
2. Initial review within 96h of injury
3. No acute findings on CT head
4. Aged 18-40 years

Exclusion Criteria:

1. Patient unable to give informed consent
2. Patient unable to speak and understand English
3. Patients where alternative diagnosis cannot be excluded
4. Polytrauma
5. Contra-indication to MRI
6. BMI >40 or unable to comfortably lie on MRI scanner
7. Pregnant
8. Major confounding neurological disease e.g Multiple sclerosis, Stroke, Parkinson's Disease.
9. Patient participation in other research studies concurrently

Study Plan

How is the study designed?

Number of groups / cohorts

2

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.	Diagnostic test: 7T MRI brain; 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.	Diagnostic test: 7T MRI brain; 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	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	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: NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: head injury; concussion; MRI brain; 7T MRI; mildTBI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries
• Other Study ID Numbers: INGN24HS153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No