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Magnetoencephalography by Optical Pumping Magnetometer (MEG OPM)

Primary Purpose

Magnetoencephalography, Optical Pump Magnetometer, Neonate

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetoencephalography
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Magnetoencephalography focused on measuring Magnetoencephalography, optical pump magnetometer, neonate, Premature

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For healthy adult volunteers Age between 18 and 65 No pathology, no treatment No toxicant intake For term newborns Child between 38 and 42 weeks gestational age on the day of registration No pathology, no treatment For children born prematurely Child between 28 and 36 weeks gestational age on the day of registration No pathology, no treatment apart from routine care related to prematurity For pregnant women Pregnant with between 28 to 40 weeks gestational age on the day of registration No pathology, no treatment Exclusion Criteria: Subject and Patients "not compatible" MEG. Wearers of prosthesis or pacemaker likely to generate artefacts interfering with the measurement. There is no danger to the subject, but the measurement itself may be impossible. Patients who cannot stand to stand still for a few minutes. Newborn on ventilatory assistance or infusion Newborn baby not meeting the age criteria

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Adults

full term neonates

premature neonates

pregnant women

Arm Description

Outcomes

Primary Outcome Measures

Signal to noise ratio of the MEG OPM
Signal to noise ratio of the MEG OPM is in dB
Signal to noise ratio of HR EEG
Signal to noise ratio of HR EEG is in dB
Number of dB between Signal to noise ratio of the MEG OPM and Signal to noise ratio of HR EEG

Secondary Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
April 26, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05835817
Brief Title
Magnetoencephalography by Optical Pumping Magnetometer
Acronym
MEG OPM
Official Title
Magnetoencephalography by Optical Pumping Magnetometer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

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
MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling. The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetoencephalography, Optical Pump Magnetometer, Neonate, Premature
Keywords
Magnetoencephalography, optical pump magnetometer, neonate, Premature

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults
Arm Type
Experimental
Arm Title
full term neonates
Arm Type
Experimental
Arm Title
premature neonates
Arm Type
Experimental
Arm Title
pregnant women
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Magnetoencephalography
Intervention Description
40 minutes of Magnetoencephalography with Optical Pump Magnetometer
Primary Outcome Measure Information:
Title
Signal to noise ratio of the MEG OPM
Description
Signal to noise ratio of the MEG OPM is in dB
Time Frame
1 day
Title
Signal to noise ratio of HR EEG
Description
Signal to noise ratio of HR EEG is in dB
Time Frame
1 day
Title
Number of dB between Signal to noise ratio of the MEG OPM and Signal to noise ratio of HR EEG
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For healthy adult volunteers Age between 18 and 65 No pathology, no treatment No toxicant intake For term newborns Child between 38 and 42 weeks gestational age on the day of registration No pathology, no treatment For children born prematurely Child between 28 and 36 weeks gestational age on the day of registration No pathology, no treatment apart from routine care related to prematurity For pregnant women Pregnant with between 28 to 40 weeks gestational age on the day of registration No pathology, no treatment Exclusion Criteria: Subject and Patients "not compatible" MEG. Wearers of prosthesis or pacemaker likely to generate artefacts interfering with the measurement. There is no danger to the subject, but the measurement itself may be impossible. Patients who cannot stand to stand still for a few minutes. Newborn on ventilatory assistance or infusion Newborn baby not meeting the age criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Wallois, Pr
Phone
03 22 08 80 51
Email
wallois.fabrice@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Wallois, Pr
Phone
(33)322087775
Email
fabrice.wallois@u-picardie.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Magnetoencephalography by Optical Pumping Magnetometer

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