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

Not Applicable

• Conditions: Patient With Pharmaco-resistant Epilepsy; Normal Subject
• Interventions: Device: MEG recordings

• Registration Number: NCT04615637
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16
• Study Start: 2021-03-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sensors	MEG recordings	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.

Primary Outcome Measures

Name	Time	Method
Signal to Noise Ratio of the recorded brain activities	1 month	Volunteers: 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 Outcome Measures

Name	Time	Method
Signal to Noise Ratio of pre-frontal auditory activity	one month	evaluate 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 activity	one 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 questionary	5 minutes after the end the recording session	The 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 questionary	5 minutes after the end of each recording session	The 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.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France