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

NCT06830616 | Not Yet Recruiting

• 1 other identifier: INGN24HS153
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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. 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. 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?

Conditions

Traumatic Brain Injury (TBI); Concussion, Initial Encounter

Keywords

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

Outcome Measures

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.

  28 +/- 14 days from head injury

Secondary Outcomes (1)

• Changes in Brain Signalling Pathways on 7T MRI

  At 28 +/- 14 days from head injury

Study Arms (2)

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

7T MRI brain DIAGNOSTIC_TEST

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

Patients who have completely recovered from concussion; Patients who have ongoing symptoms from concussion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Isolated head trauma
• Initial review within 96h of injury
• No acute findings on CT head
• Aged 18-40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Central Study Contacts

Prof Stewart

CONTACT

(0141) 354 9535; william.stewart@glasgow.ac.uk

Prof Lowe

CONTACT

(0141) 452 2932; david.lowe@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share