Traumatic Brain Injury (TBI); Concussion, Initial EncounterACME-7TNCT06830616
Acute Concussion Management in Emergency Medicine with 7T MRI: a Feasibility Study
An observational study of Traumatic Brain Injury (TBI); Concussion, Initial Encounter, run by NHS Greater Glasgow and Clyde.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Traumatic Brain Injury (TBI); Concussion, Initial Encounter
- What is being tested?
- 7T MRI brain
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients will be recruited from the Emergency Department at the Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde.
Who may be able to join
- Isolated head trauma
- Initial review within 96h of injury
- No acute findings on CT head
- Aged 18-40 years
Who cannot join
- 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
Show all 9Show fewer
- Pregnant
- Major confounding neurological disease e.g Multiple sclerosis, Stroke, Parkinson's Disease.
- Patient participation in other research studies concurrently
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
Read more
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?
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.
- Being tested
- 7T MRI brain
- Keywords
- concussion, 7T MRI, head injury, mildTBI, MRI brain
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRI brainDiagnostic test
A very detailed MRI scan of the brain using a 7T MRI scanner.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: 7T MRI brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 28 +/- 14 days from head injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI); Concussion, Initial EncounterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830616
- Sponsor's protocol ID
- INGN24HS153
- Acronym
- ACME-7T
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Concussion Management in Emergency Medicine with 7T MRI: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06830616
- Acronym / sponsor ID
- ACME-7T / INGN24HS153
- Keywords
- concussion, 7T MRI, head injury, mildTBI, MRI brain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who have completely recovered from concussion | – | Diagnostic Test: 7T MRI brainRecovery 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. |
| Patients who have ongoing symptoms from concussion | – | Diagnostic Test: 7T MRI brainRecovery 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from the Emergency Department at the Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde.
Key inclusion criteria (4 listed)
- Isolated head trauma
- Initial review within 96h of injury
- No acute findings on CT head
- Aged 18-40 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7T MRI brainA very detailed MRI scan of the brain using a 7T MRI scanner. | Diagnostic test | Patients who have completely recovered from concussion, Patients who have ongoing symptoms from concussion |
Primary outcome
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.
1 secondary outcome
Changes in Brain Signalling Pathways on 7T MRI
Time frame: At 28 +/- 14 days from head injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury (TBI); Concussion, Initial Encounter, run by NHS Greater Glasgow and Clyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Stewart ((0141) 354 9535, william.stewart@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular Pathology (Blood Vessel Changes) on 7T MRI brain (time frame: 28 +/- 14 days from head injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.