Brain Injuries, TraumaticMEGAbITNCT03867513
The Role of MEG in Assessment and Diagnosis In mTBI
An observational study of Brain Injuries, Traumatic, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Multimodal imaging
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2019to 5 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Potential participants will be identified form those attending the Emergency department of the Queen's Medical Centre, Nottingham
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MEGAbIT The Role of OPM MEG in Assessment and Diagnosis In mTBI. An Observational Study
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
- Being tested
- Multimodal imaging
- Keywords
- Magnetoencephalography, Magnetic Resonance Imaging, Mild traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal imagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Multimodal imaging | |
| Acute trauma controls | Non-head trauma controls matched for age and sex with the mTBI group Receives: Other: Multimodal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within two weeks of injury
Secondary outcomes (1)
Is the SQUID or OPM MEG system preferred by participants for tolerability and ease of use?
Participant preference for the SQUID or OPM MEG system will be recorded after both scanning sessions have been completed.
Measured: Within two weeks of injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start6 Nov 2019
- Primary completion5 May 2021 (estimated)
- Study completion5 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikos Evangelou, MD, Principal investigator, Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867513
- Sponsor's protocol ID
- 19008
- Other IDs
- 256907
- Acronym
- MEGAbIT
- Status last verified
- Nov 2020
- First submitted
- 25 Feb 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEGAbIT The Role of OPM MEG in Assessment and Diagnosis In mTBI. An Observational Study
- ClinicalTrials.gov ID
- NCT03867513
- Acronym / sponsor ID
- MEGAbIT / 19008
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Magnetoencephalography, Magnetic Resonance Imaging, Mild traumatic brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 5 May 2021 (estimated)
- Study completion
- 5 Nov 2022 (estimated)
- First posted
- 8 Mar 2019 (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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mTBI cases | – | Other: Multimodal imagingThose 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) |
| Acute trauma controls | – | Other: Multimodal imagingNon-head trauma controls matched for age and sex with the mTBI group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Potential participants will be identified form those attending the Emergency department of the Queen's Medical Centre, Nottingham
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Multimodal imagingAll 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. | Other | Acute trauma controls, mTBI cases |
Primary outcome
Can mTBI participants be differentiated from non-head injured controls by measuring brain wave activity?
Time frame: Within two weeks of injury
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.
1 secondary outcome
Is the SQUID or OPM MEG system preferred by participants for tolerability and ease of use?
Time frame: Within two weeks of injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Nikos Evangelou, MD principal investigator
Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by University of Nottingham at 1 site in United Kingdom.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can mTBI participants be differentiated from non-head injured controls by measuring brain wave activity? (time frame: Within two weeks of 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 19 Nov 2020.