The Role of MEG in Assessment and Diagnosis In mTBI

NCT03867513 | Unknown

• 2 other identifiers: 19008256907
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Brain Injuries, Traumatic

Keywords

Magnetoencephalography; Magnetic Resonance Imaging; Mild traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Can mTBI participants be differentiated from non-head injured controls by measuring brain wave activity?

  To measure and localize abnormal resting-state slow wave activity in an mTBI population in the acute stage (\< 2 weeks post injury). Voxel-wise source reconstruction of MEG resting state data using a beamforming approach will be used to generate a normative database of brain activity in the cohort of age and sex matched non-head injured trauma participants. The investigators will compare the oscillatory power in the theta and alpha frequency band between the mTBI cohort and the normative database to generate statistical maps of abnormal brain activity on a per participant basis. These will be assessed for statistically significant loci of abnormal slow wave power.

  Within two weeks of injury

Secondary Outcomes (1)

• Is the SQUID or OPM MEG system preferred by participants for tolerability and ease of use?

  Within two weeks of injury

Other Outcomes (5)

• What novel imaging measures best differentiate mTBI participants?

  Assessment within two weeks of injury, follow up for six months

• Does abnormal slow wave activity on MEG arise from areas with SWI or DTI abnormalities?

  Assessment within two weeks of injury, follow up for six months

• Does early imaging provide prognostic information?

  Assessment within two weeks of injury, follow up for six months

Study Arms (2)

mTBI cases

Those diagnosed with mild traumatic brain injury (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)

Other: Multimodal imaging

Acute trauma controls

Non-head trauma controls matched for age and sex with the mTBI group

Other: Multimodal imaging

Interventions

Multimodal imaging OTHER

All participants will attend the Sir Peter Mansfield Imaging Centre for a scanning session using three imaging systems (SQUID MEG, OPM MEG and 7T MRI), cognitive testing and symptom questionnaires. Remote symptom monitoring and cognitive testing at three and six months.

Acute trauma controls; mTBI cases

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Nikos Evangelou, MD

  Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 8, 2019
• Study Start: November 6, 2019
• Primary Completion: May 5, 2021
• Study Completion: November 5, 2022
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

GB (1)