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

Civil Hospices of Lyon

Status: Unknown

Conditions: Patient With Pharmaco-resistant Epilepsy; Normal Subject

Treatments: Device: MEG recordings

Study type: Interventional

Funder types: Other

Identifiers

NCT04615637

2020-A00634-35 (Registry Identifier)

69HCL20_0191

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Sensors

Experimental group

Description:

All subjects will follow the same experimental procedure: a recording using classical MEG followed by a recording in the same condition with the OPM He4 prototype.

Treatment:

Device: MEG recordings