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NCT Number: NCT06830616

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

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?

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Key information

Conditions

Traumatic Brain Injury (TBI); Concussion, Initial Encounter Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7T MRI brain

Diagnostic Test

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

Primary outcomes

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.

Secondary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof Lowe

CONTACT

[email protected]

(0141) 452 2932

Prof Stewart

CONTACT

[email protected]

(0141) 354 9535

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Registry information

Acronym: ACME-7T

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 17, 2025
Registry last updated: Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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