Clinical trial NCT04615637: Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging
Official title: Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Subject
Patient With Pharmaco-resistant Epilepsy
Keywords: MEG
OPM
epilepsy
normal brain activity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Signal to Noise Ratio of the recorded brain activities
timeFrame: 1 month
Secondary outcomes:
measure: Signal to Noise Ratio of pre-frontal auditory activity
timeFrame: one month
measure: Signal to Noise Ratio of high frequency epileptic activity
timeFrame: one month.
measure: Comfort of the subject during the MPO He4 recordings for epileptic patient through a short verbal questionary
timeFrame: 5 minutes after the end the recording session
measure: Comfort of the subject during the MPO He4 recordings for volunteers through a short verbal questionary
timeFrame: 5 minutes after the end of each recording session
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Julien JUNG, MD
role: PRINCIPAL_INVESTIGATOR
References: