Magnetoencephalography by Optical Pumping Magnetometer (MEG OPM)

May 22, 2025 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

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 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adults
Other: Magnetoencephalography
40 minutes of Magnetoencephalography with Optical Pump Magnetometer
Experimental: full term neonates
Other: Magnetoencephalography
40 minutes of Magnetoencephalography with Optical Pump Magnetometer
Experimental: premature neonates
Other: Magnetoencephalography
40 minutes of Magnetoencephalography with Optical Pump Magnetometer
Experimental: pregnant women
Other: Magnetoencephalography
40 minutes of Magnetoencephalography with Optical Pump Magnetometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal to noise ratio of the MEG OPM
Time Frame: 1 day
Signal to noise ratio of the MEG OPM is in dB
1 day
Signal to noise ratio of HR EEG
Time Frame: 1 day
Signal to noise ratio of HR EEG is in dB
1 day
Number of dB between Signal to noise ratio of the MEG OPM and Signal to noise ratio of HR EEG
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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 (Actual)

April 11, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2021_843_0205

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

product manufactured in and exported from the U.S.

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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