MagnetoencephalographyMEG OPMNCT05835817
Magnetoencephalography by Optical Pumping Magnetometer
A study testing Magnetoencephalography in people with Magnetoencephalography and Optical Pump Magnetometer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Magnetoencephalography, Optical Pump Magnetometer, Neonate
- What is being tested?
- Magnetoencephalography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Fabrice Wallois, Pr, (33)322087775, fabrice.wallois@u-picardie.fr
About this study
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.
- Conditions
- Magnetoencephalography, Optical Pump Magnetometer, Neonate, Premature
- Being tested
- Magnetoencephalography
- Keywords
- Magnetoencephalography, optical pump magnetometer, neonate, Premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetoencephalographyOther
40 minutes of Magnetoencephalography with Optical Pump Magnetometer
| Study group | Role | What they receive |
|---|---|---|
| Adults | Experimental | Not described Receives: Other: Magnetoencephalography |
| full term neonates | Experimental | Not described Receives: Other: Magnetoencephalography |
| premature neonates | Experimental | Not described Receives: Other: Magnetoencephalography |
| pregnant women | Experimental | Not described Receives: Other: Magnetoencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal to noise ratio of the MEG OPM
Signal to noise ratio of the MEG OPM is in dB
Measured: 1 day
Signal to noise ratio of HR EEG
Signal to noise ratio of HR EEG is in dB
Measured: 1 day
Number of dB between Signal to noise ratio of the MEG OPM and Signal to noise ratio of HR EEG
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start11 Apr 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MagnetoencephalographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835817
- Sponsor's protocol ID
- PI2021_843_0205
- Acronym
- MEG OPM
- Status last verified
- May 2025
- First submitted
- 13 Apr 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetoencephalography by Optical Pumping Magnetometer
- ClinicalTrials.gov ID
- NCT05835817
- Acronym / sponsor ID
- MEG OPM / PI2021_843_0205
- Conditions
- Magnetoencephalography, Optical Pump Magnetometer, Neonate, Premature
- Keywords
- Magnetoencephalography, optical pump magnetometer, neonate, Premature
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adults | Experimental | Other: Magnetoencephalography |
| full term neonates | Experimental | Other: Magnetoencephalography |
| premature neonates | Experimental | Other: Magnetoencephalography |
| pregnant women | Experimental | Other: Magnetoencephalography |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- For healthy adult volunteers
- Age between 18 and 65
- No pathology, no treatment
- No toxicant intake
- For term newborns
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetoencephalography40 minutes of Magnetoencephalography with Optical Pump Magnetometer | Other | Adults, full term neonates, pregnant women, premature neonates |
Primary outcome
Signal to noise ratio of the MEG OPM
Time frame: 1 day
Signal to noise ratio of the MEG OPM is in dB
Signal to noise ratio of HR EEG
Time frame: 1 day
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
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetoencephalography in people with Magnetoencephalography and Optical Pump Magnetometer, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Wallois, Pr (03 22 08 80 51, wallois.fabrice@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal to noise ratio of the MEG OPM (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.