Using advanced magnetoencephalography to study brain development in newborns and adults
Magnetoencephalography by Optical Pumping Magnetometer
This study is testing a new way to measure brain activity in healthy adults, term newborns, and premature infants to better understand how their brains develop.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 1 Day and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05835817 on ClinicalTrials.gov |
What this trial studies
This project aims to utilize Magnetoencephalography (MEG) with Optical Pumping Magnetometers (OPM) to identify biomarkers of normal brain development in healthy adults, term newborns, and premature infants. The study seeks to overcome the limitations of traditional MEG methods that rely on costly Super Quantum Interference Devices (SQUID) by employing OPM sensors, which do not require helium cooling. Participants will include healthy adults aged 18-65, term newborns, and premature infants within specified gestational age ranges, all without any pathologies. The study will involve recording brain activity to enhance understanding of brain development.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18-65, term newborns between 38-42 weeks gestational age, and premature infants between 28-36 weeks gestational age.
Not a fit: Patients with pathologies, those requiring ventilatory assistance, or individuals with prosthetics that interfere with MEG measurements will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into brain development, potentially leading to improved diagnostic and therapeutic strategies for premature infants.
How similar studies have performed: While the use of OPM in MEG is a promising approach, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Fabrice Wallois, Pr
- Email: wallois.fabrice@chu-amiens.fr
- Phone: 03 22 08 80 51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.