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

February 15, 2021 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensors
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.
Device: MEG 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal to Noise Ratio of the recorded brain activities
Time Frame: 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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal to Noise Ratio of pre-frontal auditory activity
Time Frame: 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
one month
Signal to Noise Ratio of high frequency epileptic activity
Time Frame: one month.
evaluate the capacities of our MPO to record high frequency epileptic signal which are not recorded by current generation of MPO
one month.
Comfort of the subject during the MPO He4 recordings for epileptic patient through a short verbal questionary
Time Frame: 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.
5 minutes after the end the recording session
Comfort of the subject during the MPO He4 recordings for volunteers through a short verbal questionary
Time Frame: 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.
5 minutes after the end of each recording session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Julien JUNG, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_0191
  • 2020-A00634-35 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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