Evaluation of Optical Pumping Magnetometer Sensors for Ma... | NCT04694313

Studies
Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging

NCT04694313

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Apr 15, 2026Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Epilepsy

Interventions

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A01830-39	Other Identifier	ID-RCD

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2021Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 1, 2022Actual

First Submitted Date

Dec 30, 2020

First Submission Date that Met QC Criteria

Jan 4, 2021

First Posted Date

Jan 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2026

Last Update Posted Date

Apr 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research is a feasibility study on a new generation of brain magnetic activity sensor which should allow the development of this modality, until now limited by its cost to a few large university centers.

The measurement of magnetic activity allows the detection and localization of abnormal activities such as paroxysmal events occurring between seizures in patients with epilepsy as well as research into brain function. It is the only one, along with EEG and related techniques, to provide data related to the speed of the brain. MEG, by virtue of the properties of magnetic fields, has a greater potential than EEG for the detection and localization of the neuronal sources which cause it.

The MEG sensors used until now use Superconducting Quantum Interference Devices (SQUID) components that are extremely sensitive but require complex instrumentation and only operate under superconducting conditions, resulting in prohibitive maintenance and cost.

The alternative could come from a new magnetic activity sensor: the optical pumping magnetometers of the alkaline type.

This preliminary study proposes to compare SQUID sensors with MPO He4 sensors for their ability to detect abnormal activities recorded in epileptic patients. Measurements that cannot be recorded simultaneously Two types of measurement will be compared with the reference that constitutes in-depth recording (Stereotactic-EEG or SEEG) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures.

The expected results are a capacity of this type of sensors to detect epileptic activities equivalent to that of SQUIDs.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OPM	Experimental	Two types of measurement will be compared (SQUID and OPM) with the reference that constitutes the in-depth recordings (Stereotactic-EEG or SEEG) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures.	Device: OPM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPM	Device	Simultaneous MEG SQUID + SEEG acquisition followed by a simultaneous MEG OPM + SEEG acquisition.	OPM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Signal to noise ratio visible on the sensors	Interictal peaks or oscillations in different frequency bands (gamma, ripples, fast ripples)	Visit 0 at month 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient (≥ 18 years old)
Patient with drug-resistant focal epilepsy, undergoing SEEG exploration
Healthy subject, devoid of central neurological pathology, major ((≥ 18 years)
Patient or healthy subject capable of giving informed consent for the study

Exclusion Criteria:

MEG "incompatible" healthy patients or volunteers.
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 or healthy volunteers who cannot stand standing still for a few minutes.
Pregnant or breastfeeding women
Adults under guardianship or under legal protection
People deprived of their liberty
People who have not signed the informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
François CREMIEUX	Assistance Publique Hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM		Marseille		13885	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37932045	Result	Badier JM, Schwartz D, Benar CG, Kanzari K, Daligault S, Romain R, Mitryukovskiy S, Fourcault W, Josselin V, Le Prado M, Jung J, Palacios-Laloy A, Romain C, Bartolomei F, Labyt E, Bonini F. Helium Optically Pumped Magnetometers Can Detect Epileptic Abnormalities as Well as SQUIDs as Shown by Intracerebral Recordings. eNeuro. 2023 Dec 22;10(12):ENEURO.0222-23.2023. doi: 10.1523/ENEURO.0222-23.2023. Print 2023 Dec.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases