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Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging

Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04615637
Acronym
NEW MEG
Enrollment
45
Registered
2020-11-04
Start date
2021-03-01
Completion date
2023-07-01
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Subject, Patient With Pharmaco-resistant Epilepsy

Keywords

MEG, OPM, epilepsy, normal brain activity

Brief summary

Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. The investigator will compare the signal to noise ratio of the normal or pathological activities between classical MEG sensors and our OPM He4 prototype.

Interventions

DEVICEMEG recordings

1. Classical MEG recordings (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli). 2. MEG recordings with our OPM He4 prototype (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Volunteers: * Age 18+ * Right handed * Medical insurance * Strongly motivated to participate to the study * Signed informed consent for the study * No previous neurology or psychiatric pathologies * No major cognitive deficit and able to understand the instructions Patients: * Age 18+ * Right handed * Medical insurance * Strongly motivated to participate to the study * Signed informed consent for the study * No previous neurology or psychiatric pathologies (except epilepsy) * Epilepsy evolving during at least two years * No major cognitive deficit and able to understand the instructions

Exclusion criteria

Volunteers: * Age \< 18 years or \> 60 * previous neurology or psychiatric pathologies * Child bearing women * Subject having one of the following mettalic parts : * (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve) * Claustrophobia Woman with a positive pregnancy test during the inclusion. Patients: Age \< 18 years or \> 60 * previous neurology or psychiatric pathologies except epilepsy * Child bearing women * Subject having one of the following mettalic parts : * (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve) * Claustrophobia Woman with a positive pregnancy test during the inclusion.

Design outcomes

Primary

MeasureTime frameDescription
Signal to Noise Ratio of the recorded brain activities1 monthVolunteers: The signal to noise ratio of normal brain activity following a stimulus will be computed with respect to the pre-stimulus baseline -100ms to -10 ms. Epileptic patient: The signal to noise ratio of abnormal epileptic brain activity will be computed with respect to a 100 ms baseline not containing any abnormal activity.

Secondary

MeasureTime frameDescription
Signal to Noise Ratio of pre-frontal auditory activityone monthevaluate the capacities of MPO to record pre-frontal auditory activities which are not recorded by classical MEG. EEG will be the reference
Signal to Noise Ratio of high frequency epileptic activityone month.evaluate the capacities of our MPO to record high frequency epileptic signal which are not recorded by current generation of MPO
Comfort of the subject during the MPO He4 recordings for epileptic patient through a short verbal questionary5 minutes after the end the recording sessionThe evaluation will be done verbally through a short questionary. This questionary evaluates the overall comfort of the MPO system with two questions: 1) An evaluation of the overall comfort thanks to a scale with five steps from very uncomfortable to very comfortable and 2) A comparison with the classical MEG system thanks to a 5 steps scale from much less comfortable than the classical MEG system to much more comfortable.
Comfort of the subject during the MPO He4 recordings for volunteers through a short verbal questionary5 minutes after the end of each recording sessionThe evaluation will be done verbally through a short questionary. This questionary evaluates the overall comfort of the MPO system with two questions: 1) An evaluation of the overall comfort thanks to a scale with five steps from very uncomfortable to very comfortable and 2) A comparison with the classical MEG system thanks to a 5 steps scale from much less comfortable than the classical MEG system to much more comfortable.

Countries

France

Contacts

Primary ContactJulien JUNG, MD
julien.jung@chu-lyon.fr04.72.35.79.00
Backup ContactDenis SCHWARTZ, MD
denis.schwartz@inserm.fr04.72.13.89.61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026