Clinical trial NCT03867513: The Role of MEG in Assessment and Diagnosis In mTBI
Official title: MEGAbIT The Role of OPM MEG in Assessment and Diagnosis In mTBI. An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries, Traumatic
Keywords: Magnetoencephalography
Magnetic Resonance Imaging
Mild traumatic brain injury
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be identified form those attending the Emergency department of the Queen's Medical Centre, Nottingham

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 persistent symptoms. The investigators aim to use the latest generation of imaging technology to investigate those with mild traumatic brain injury (mTBI) to better assess them.

The investigators will invite patients presenting following trauma to the Emergency Department at Queen's Medical Centre, Nottingham, UK to participate. The investigators will compare those who have a suffered an mTBI to those who have non-head traumatic injuries. The investigators will use two magnetoencephalogram (MEG) systems and ultra-high field magnetic resonance imaging (MRI) to record the functioning and structure of the brain within days of participants' injury. The investigators will test memory and thinking skills, then follow participants for six months, record the severity of participants' symptoms, and find out who does not make a full recovery.

Multimodal imaging will consist of a standard MEG device using Superconducting Quantum Interference Device (SQUID) sensors, a novel MEG device using Optically Pumped Magnetometer (OPM) sensors and seven Tesla MRI. The investigators will test whether these innovative imaging techniques are more sensitive to the acute damage that mTBI causes than routine imaging. The investigators will also test whether early imaging can reveal who is most seriously affected, identifying those who will not recover without additional support. It is currently not clear what the predominant mechanism of damage that causes these long-term problems is and the investigators hope this study will address this. The Medical Research Council is funding this work


Eligibility criteria: 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:

  1. 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)
  2. 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.

Primary outcomes:
measure: Can mTBI participants be differentiated from non-head injured controls by measuring brain wave activity?
timeFrame: Within two weeks of injury
Secondary outcomes:
measure: Is the SQUID or OPM MEG system preferred by participants for tolerability and ease of use?
timeFrame: Within two weeks of injury
Other outcomes:
measure: What novel imaging measures best differentiate mTBI participants?
timeFrame: Assessment within two weeks of injury, follow up for six months
measure: Does abnormal slow wave activity on MEG arise from areas with SWI or DTI abnormalities?
timeFrame: Assessment within two weeks of injury, follow up for six months
measure: Does early imaging provide prognostic information?
timeFrame: Assessment within two weeks of injury, follow up for six months
measure: Is there a failure of the network responsible for attention switching in mTBI and is this correlated with objective deficits?
timeFrame: Assessment within two weeks of injury, follow up for six months
measure: Is there a failure of the network responsible for working memory in mTBI and is this correlated with objective deficits?
timeFrame: Assessment within two weeks of injury, follow up for six months
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK
name: Nikos Evangelou, MD
role: PRINCIPAL_INVESTIGATOR
References: