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The Role of MEG in Assessment and Diagnosis In mTBI (MEGAbIT)

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ClinicalTrials.gov Identifier: NCT03867513
Recruitment Status : Enrolling by invitation
First Posted : March 8, 2019
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Tracking Information
First Submitted Date February 25, 2019
First Posted Date March 8, 2019
Last Update Posted Date November 19, 2020
Actual Study Start Date November 6, 2019
Estimated Primary Completion Date May 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 5, 2019)
Is the SQUID or OPM MEG system preferred by participants for tolerability and ease of use? [ Time Frame: Within two weeks of injury ]
Participant preference for the SQUID or OPM MEG system will be recorded after both scanning sessions have been completed.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2019)
  • What novel imaging measures best differentiate mTBI participants? [ Time Frame: Assessment within two weeks of injury, follow up for six months ]
    To measure whole-brain connectivity in the resting state between regions defined via the automated anatomical labeling atlas. This will be achieved using amplitude envelope correlation between all signals originating from each region. Measures of node strength and overall connectivity will be calculated to investigate the efficiency of communication between brain regions in the participants' brains. The investigators will also measure structural connectivity using a diffusion tensor imaging (DTI) MRI sequence and structural damage using high-resolution susceptibility weighted imaging (SWI) MRI sequence. DTI will generate volumetric maps of fractional anisotropy.
  • Does abnormal slow wave activity on MEG arise from areas with SWI or DTI abnormalities? [ Time Frame: Assessment within two weeks of injury, follow up for six months ]
    Compare per participant theta and alpha MEG power maps generated in the primary analysis with DTI and SWI MRI scans. Using volumetric quantitative techniques compare which MRI sequence better explains the variation in MEG signal.
  • Does early imaging provide prognostic information? [ Time Frame: Assessment within two weeks of injury, follow up for six months ]
    Using a multivariate statistical model explore if baseline neuropsychological testing scores or memory task ability and symptom scales at six months correlate with baseline MEG and imaging abnormalities.
  • Is there a failure of the network responsible for attention switching in mTBI and is this correlated with objective deficits? [ Time Frame: Assessment within two weeks of injury, follow up for six months ]
    Using a visual attention MEG protocol the investigators will assess participants' ability to switch their attention to different areas of their visual field during a task. The investigators anticipate the normally observed relative reduction in alpha and increase in gamma power over the contralateral occipital lobe will be disrupted in the mTBI participants compared to controls. The investigators hypothesis that this will be linked to worse task performance and they will compare whether both failure to modulate power and task performance are correlated with objective clinical measures.
  • Is there a failure of the network responsible for working memory in mTBI and is this correlated with objective deficits? [ Time Frame: Assessment within two weeks of injury, follow up for six months ]
    Using an N-back working memory MEG protocol the investigators will assess participants' memory for worse task performance in the acute mTBI cohort and they will compare whether both MEG signal change and task performance are correlated with objective clinical measures.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Brain Injuries, Traumatic
Intervention Other: Multimodal imaging
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 Groups/Cohorts
  • 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)
    Intervention: Other: Multimodal imaging
  • Acute trauma controls
    Non-head trauma controls matched for age and sex with the mTBI group
    Intervention: Other: Multimodal imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: March 5, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 5, 2022
Estimated Primary Completion Date May 5, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03867513
Other Study ID Numbers 19008
256907 ( Other Identifier: IRAS Project ID )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Nottingham
Study Sponsor University of Nottingham
Collaborators Not Provided
Investigators
Principal Investigator: Nikos Evangelou, MD Clinical Neurology, Division of Clinical Neuroscience, University of Nottingham, UK
PRS Account University of Nottingham
Verification Date November 2020