Clinical Trials Directory

Trials / Unknown

UnknownNCT03867513

The Role of MEG in Assessment and Diagnosis In mTBI

MEGAbIT The Role of OPM MEG in Assessment and Diagnosis In mTBI. An Observational Study

Status
Unknown
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
University of Nottingham · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERMultimodal 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.

Timeline

Start date
2019-11-06
Primary completion
2021-05-05
Completion
2022-11-05
First posted
2019-03-08
Last updated
2020-11-19

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03867513. Inclusion in this directory is not an endorsement.