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

Primary Purpose

Normal Subject, Patient With Pharmaco-resistant Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MEG recordings
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Normal Subject focused on measuring MEG, OPM, epilepsy, normal brain activity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sensors

Arm 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.

Outcomes

Primary Outcome Measures

Signal to Noise Ratio of the recorded brain activities
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

Signal to Noise Ratio of pre-frontal auditory activity
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
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
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
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.

Full Information

First Posted
July 8, 2020
Last Updated
February 15, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04615637
Brief Title
Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging
Acronym
NEW MEG
Official Title
Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Subject, Patient With Pharmaco-resistant Epilepsy
Keywords
MEG, OPM, epilepsy, normal brain activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sensors
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
MEG recordings
Intervention Description
Classical MEG recordings (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli). MEG recordings with our OPM He4 prototype (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).
Primary Outcome Measure Information:
Title
Signal to Noise Ratio of the recorded brain activities
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Signal to Noise Ratio of pre-frontal auditory activity
Description
evaluate the capacities of MPO to record pre-frontal auditory activities which are not recorded by classical MEG. EEG will be the reference
Time Frame
one month
Title
Signal to Noise Ratio of high frequency epileptic activity
Description
evaluate the capacities of our MPO to record high frequency epileptic signal which are not recorded by current generation of MPO
Time Frame
one month.
Title
Comfort of the subject during the MPO He4 recordings for epileptic patient through a short verbal questionary
Description
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.
Time Frame
5 minutes after the end the recording session
Title
Comfort of the subject during the MPO He4 recordings for volunteers through a short verbal questionary
Description
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.
Time Frame
5 minutes after the end of each recording session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien JUNG, MD
Phone
04.72.35.79.00
Email
julien.jung@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Denis SCHWARTZ, MD
Phone
04.72.13.89.61
Email
denis.schwartz@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien JUNG, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien JUNG, MD
Phone
04 72 35 79 00
Email
julien.jung@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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