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Clinical Trials/NCT04615637
NCT04615637UnknownNot Applicable

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

Hospices Civils de Lyon1 site in 1 country45 target enrollmentStarted: March 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
45
Locations
1
Primary Endpoint
Signal to Noise Ratio of the recorded brain activities

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Volunteers:
  • •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
  • •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.
  • •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.

Arms & Interventions

Sensors

Experimental

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: MEG recordings (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Signal to Noise Ratio of pre-frontal auditory activity(one month)
  • Signal to Noise Ratio of high frequency epileptic activity(one month.)
  • 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)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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