Whole-head helium-4 optically pumped magnetometer (OPM He4) brain scanner for faster brain recordings
Towards a New Generation of Magnetoencephalographs: Evaluation of the FYNA Research (Mag4Health 48 Sensors MEG's Name) System (Full-head Magnetoencephalographs System With Optically Pumped Magnetometers)
This project will test whether a new whole-head brain scanner using helium-4 sensors can pick up and map brain activity in healthy adults and athletes with mild concussion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT06244472 on ClinicalTrials.gov |
What this trial studies
This interventional project uses a new generation of non-invasive magnetoencephalography (MEG) sensors based on helium-4 optically pumped magnetometers to record brain magnetic activity. Investigators will record responses in healthy volunteers during visual, auditory, somatosensory, motor, language, and rest tasks and will also record athletes who experienced a mild concussion. The main comparison is signal-to-noise ratio between the new OPM He4 MEG and a conventional MEG system, and a secondary comparison will test whether brain activity maps reconstructed from OPM He4 data match those from conventional MEG. All recordings are performed on-site at Hospices Civils de Lyon facilities using standardized tasks to permit direct device-to-device comparison.
Who should consider this trial
Good fit: Ideal candidates are motivated adults aged 18–70 who are either healthy volunteers or athletes with a history of mild concussion and who have no neurological, psychiatric, or MRI/MEG contraindications.
Not a fit: People with implanted metal devices or other MEG/MRI contraindications, pregnant women, those with major cognitive or psychiatric disorders, or legally protected/incarcerated individuals would not be expected to benefit or be eligible.
Why it matters
Potential benefit: If successful, the new OPM He4 MEG could enable faster, more sensitive, and more flexible non-invasive brain recordings that improve detection and mapping of brain activity after concussion.
How similar studies have performed: Other optically pumped magnetometer MEG systems (mostly rubidium-based) have shown promising results in humans, but whole-head helium-4 OPM MEG is a novel approach with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
Healthy volunteers: Inclusion Criteria: * Age 18 to 70 * Strongly motivated to participate to the study * Signed informed consent for the study Exclusion Criteria: * major cognitive deficit and unable to understand the instructions * previous neurology or psychiatric or sleep pathologies * Woman with a positive pregnancy test during the inclusion. * Subjects under guardianship, curatorship or safeguard of justice protection * Subjects deprived of their liberty * Subject not affiliated to a social security system. * Subject with common contraindications to MEG and MRI examination : * Metal in the body incompatible with performance of the examination (pacemaker, implantable pump, neurostimulator, cochlear implant, auditory prothesis, metalic prothesis, intracerebral clip, implantable defibrillator, any metalic parts in the brain or upper part of the body, ventriculoperitoneal valve, dental appliance or steel pivot for root canal, ferromagnetic foreign body in the upper part of the upper part of the body) * Claustrophobia Subjects who suffered a mild concussion: Inclusion Criteria: * Male aged from 18 to 40 * Strongly motivated to participate to the study * Signed informed consent for the study * Mild concussion confirmed by the club doctor and a neurologist neurologist in the three weeks preceding the experiment Exclusion Criteria: * major cognitive deficit and unability to understand the instructions * previous neurology or psychiatric or sleep pathologies except mild concussion * Woman with a positive pregnancy test during the inclusion. * Subjects under guardianship, curatorship or safeguard of justice protection * Subjects deprived of their liberty * Subject not affiliated to a social security system * Subject with common contraindications to MEG and MRI examination : * Metal in the body incompatible with performance of the examination (pacemaker, implantable pump, neurostimulator, cochlear implant, auditory prothesis, metalic prothesis, intracerebral clip, implantable defibrillator, any metalic parts in the brain or upper part of the body, ventriculoperitoneal valve, dental appliance or steel pivot for root canal, ferromagnetic foreign body in the upper part of the upper part of the body) * Claustrophobia
Where this trial is running
Bron and 1 other locations
- Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon — Bron, France (Recruiting)
- Centre Orthopédique Paul Santy — Lyon, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Julien JUNG, MD — Service d'Epilepsie et Explorations fonctionnelles neurologiques,Hôpital Neurologique P. Wertheimer, Groupement Hospitalier Est, HCL
- Study coordinator: Julien JUNG, MD
- Email: julien.jung@chu-lyon.fr
- Phone: 04.72.35.79.00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.