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

NCT04615637 | Unknown

• 2 other identifiers: 69HCL20_01912020-A00634-35
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Subject; Patient With Pharmaco-resistant Epilepsy

Keywords

MEG; OPM; epilepsy; normal brain activity

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Device: MEG recordings

Interventions

MEG recordings DEVICE

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).

Sensors

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Julien JUNG, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien JUNG, MD

CONTACT

04.72.35.79.00; julien.jung@chu-lyon.fr

Denis SCHWARTZ, MD

CONTACT

04.72.13.89.61; denis.schwartz@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: November 4, 2020
• Study Start: March 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)