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Not yet recruitingNCT06830616ACME-7TUpdated Feb 20, 2025

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

An observational study in Traumatic Brain Injury (TBI); Concussion, Initial Encounter, sponsored by NHS Greater Glasgow and Clyde. Not yet recruiting. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by NHS Greater Glasgow and Clyde · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 40 Years
Sex
All
01

Study 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?
Read the 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.

02

Conditions studied

  • Traumatic Brain Injury (TBI); Concussion, Initial Encounter

Keywords

  • concussion
  • 7T MRI
  • head injury
  • mildTBI
  • MRI brain
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Diagnostic test7T MRI brain

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06830616
Lead sponsor
NHS Greater Glasgow and Clyde
Responsible party
Sponsor
First posted
Feb 17, 2025
Start date
Feb 2025 (estimated)
Primary completion
Aug 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Feb 20, 2025

Study contacts

Prof Stewart
Contact
william.stewart@glasgow.ac.uk
(0141) 354 9535
Prof Lowe
Contact
david.lowe@glasgow.ac.uk
(0141) 452 2932

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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