NCT05835817

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

April 13, 2023

Last Update Submit

May 22, 2025

Conditions

MagnetoencephalographyOptical Pump MagnetometerNeonatePremature

Keywords

Magnetoencephalographyoptical pump magnetometerneonatePremature

Outcome Measures

Primary Outcomes (3)

  • Signal to noise ratio of the MEG OPM

    Signal to noise ratio of the MEG OPM is in dB

    1 day

  • Signal to noise ratio of HR EEG

    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

    1 day

Study Arms (4)

Adults

EXPERIMENTAL
Other: Magnetoencephalography

full term neonates

EXPERIMENTAL
Other: Magnetoencephalography

premature neonates

EXPERIMENTAL
Other: Magnetoencephalography

pregnant women

EXPERIMENTAL
Other: Magnetoencephalography

Interventions

MagnetoencephalographyOTHER

40 minutes of Magnetoencephalography with Optical Pump Magnetometer

Adultsfull term neonatespregnant womenpremature neonates

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Magnetoencephalography

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

Central Study Contacts

Fabrice Wallois, Pr

CONTACT

03 22 08 80 51wallois.fabrice@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 28, 2023

Study Start

April 11, 2023

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)