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Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging (OPM)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OPM
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPM

Arm Description

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.

Outcomes

Primary Outcome Measures

Signal to noise ratio visible on the sensors
Interictal peaks or oscillations in different frequency bands (gamma, ripples, fast ripples)

Secondary Outcome Measures

Full Information

First Posted
December 30, 2020
Last Updated
July 19, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04694313
Brief Title
Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging
Acronym
OPM
Official Title
Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
OPM
Intervention Description
Simultaneous MEG SQUID + SEEG acquisition followed by a simultaneous MEG OPM + SEEG acquisition.
Primary Outcome Measure Information:
Title
Signal to noise ratio visible on the sensors
Description
Interictal peaks or oscillations in different frequency bands (gamma, ripples, fast ripples)
Time Frame
Visit 0 at month 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CREMIEUX
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM
City
Marseille
ZIP/Postal Code
13885
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging

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