Status:
UNKNOWN
The Role of MEG in Assessment and Diagnosis In mTBI
Lead Sponsor:
University of Nottingham
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
18-35 years
Brief Summary
Head injuries are responsible for 1.4 million visits to hospital each year in the United Kingdom (UK). Most patients are allowed home the same day and make a full recovery, but some will have persiste...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged 18-35
- In the Investigator's opinion, is able and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner to be notified of participation in the study
- Two groups will be recruited:
- Diagnosed by the clinical ED team with mTBI (without abnormality on standard brain structural imaging, LOC ≤30mins, amnesia for ≤24hours, GCS ≥13 at all times and recovery to GCS 15 within 24hours)
- Diagnosed by the clinical ED team with non-head trauma, matched for age and sex with the mTBI group.
- Exclusion criteria
- Patient requiring hospitalisation for ≥24 hours at presentation
- Any contraindication to undergo 7T MRI scan
- Pregnancy
- Other neurological, developmental or psychiatric disorders e.g. brain tumour, stroke, epilepsy, Alzheimer disease, schizophrenia, post-traumatic stress disorder, major depressive disorder, bipolar disorder or history of learning disability
- Previous hospital attendance with TBI
- Substance or alcohol abuse within six months of enrolment
- Taking certain medications thought to alter MEG signals: opioids and synthetic opioids (excluding codeine and dihydrocodeine), anti-epileptic drugs, sedatives, neuroleptics, and hypnotics
- Extensive metal dental hardware e.g. braces and large metal dentures (excluding fillings), implanted medical devices or other metal objects in the head, neck, or face areas that although they hold no risk to participants during a MEG recording may cause non-removable artefacts in the MEG data.
- Participants who have participated in another research study involving an investigational product in the past 12 weeks.
- Any other significant disease or disorder, which, in the opinion of the Investigator, may put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Exclusion
Key Trial Info
Start Date :
November 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 5 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03867513
Start Date
November 6 2019
End Date
November 5 2022
Last Update
November 19 2020
Active Locations (1)
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1
University of Nottingham
Nottingham, United Kingdom