Magnetoencephalography by Optical Pumping Magnetometer

Premature Clinical Trial

— MEG OPM  

Official title:

Magnetoencephalography by Optical Pumping Magnetometer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835817
• Other study ID #: PI2021_843_0205
• Status: Recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: April 2026

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Fabrice Wallois, Pr
• Phone: 03 22 08 80 51
• Email: wallois.fabrice[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day and older

Eligibility

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

Related Conditions & MeSH terms

• Neonate
• Premature
• Premature Birth

Intervention

Other:
• Magnetoencephalography
40 minutes of Magnetoencephalography with Optical Pump Magnetometer

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal to noise ratio of the MEG OPM	Signal to noise ratio of the MEG OPM is in dB	1 day
Primary	Signal to noise ratio of HR EEG	Signal to noise ratio of HR EEG is in dB	1 day
Primary	Number of dB between Signal to noise ratio of the MEG OPM and Signal to noise ratio of HR EEG		1 day