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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06830616
Acronym
ACME-7T
Enrollment
20
Registered
2025-02-17
Start date
2025-02-28
Completion date
2025-11-30
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury (TBI); Concussion, Initial Encounter

Keywords

concussion, 7T MRI, head injury, mildTBI, MRI brain

Brief summary

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_TEST7T MRI brain

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

Sponsors

NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Microvascular Pathology (Blood Vessel Changes) on 7T MRI brain28 +/- 14 days from head injuryTo 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.

Secondary

MeasureTime frameDescription
Changes in Brain Signalling Pathways on 7T MRIAt 28 +/- 14 days from head injuryTo 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.

Contacts

Primary ContactProf Stewart
william.stewart@glasgow.ac.uk(0141) 354 9535
Backup ContactProf Lowe
david.lowe@glasgow.ac.uk(0141) 452 2932

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026