Normal SubjectNEW MEGNCT04615637
Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging
A study testing MEG recordings in people with Normal Subject and Patient With Pharmaco-resistant Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Subject, Patient With Pharmaco-resistant Epilepsy
- What is being tested?
- MEG recordings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers:
- Age 18+
- Right handed
- Medical insurance
- Strongly motivated to participate to the study
- Signed informed consent for the study
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- No previous neurology or psychiatric pathologies
- No major cognitive deficit and able to understand the instructions
- Patients:
- Age 18+
- Right handed
- Medical insurance
- Strongly motivated to participate to the study
- Signed informed consent for the study
- No previous neurology or psychiatric pathologies (except epilepsy)
- Epilepsy evolving during at least two years
- No major cognitive deficit and able to understand the instructions
Who cannot join
- Volunteers:
- Age < 18 years or > 60
- previous neurology or psychiatric pathologies
- Child bearing women
- Subject having one of the following mettalic parts :
- (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve)
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- Claustrophobia Woman with a positive pregnancy test during the inclusion.
- Patients:
- Age < 18 years or > 60
- previous neurology or psychiatric pathologies except epilepsy
- Child bearing women
- Subject having one of the following mettalic parts :
- (pacemaker, implentable pump, neurosimulator, chochlear implant, auditory prothesis, mettalic prothesis, intracerebral clip, implantable defibrilator, any mettalic parts in the brain or upper part of the body, ventriculoperitoneal valve)
- Claustrophobia Woman with a positive pregnancy test during the inclusion.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon
Bron, 69500
Julien JUNG, MD, 04 72 35 79 00, julien.jung@chu-lyon.fr
About this study
Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. The investigator will compare the signal to noise ratio of the normal or pathological activities between classical MEG sensors and our OPM He4 prototype.
- Being tested
- MEG recordings
- Keywords
- MEG, OPM, epilepsy, normal brain activity
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEG recordingsDevice
- Classical MEG recordings (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).
- MEG recordings with our OPM He4 prototype (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).
| Study group | Role | What they receive |
|---|---|---|
| Sensors | Experimental | All subjects will follow the same experimental procedure: a recording using classical MEG followed by a recording in the same condition with the OPM He4 prototype. Receives: Device: MEG recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal to Noise Ratio of the recorded brain activities
Volunteers: The signal to noise ratio of normal brain activity following a stimulus will be computed with respect to the pre-stimulus baseline -100ms to -10 ms.
Epileptic patient: The signal to noise ratio of abnormal epileptic brain activity will be computed with respect to a 100 ms baseline not containing any abnormal activity.
Measured: 1 month
Secondary outcomes (4)
Signal to Noise Ratio of pre-frontal auditory activity
evaluate the capacities of MPO to record pre-frontal auditory activities which are not recorded by classical MEG. EEG will be the reference
Measured: one month
Signal to Noise Ratio of high frequency epileptic activity
evaluate the capacities of our MPO to record high frequency epileptic signal which are not recorded by current generation of MPO
Measured: one month.
Comfort of the subject during the MPO He4 recordings for epileptic patient through a short verbal questionary
The evaluation will be done verbally through a short questionary. This questionary evaluates the overall comfort of the MPO system with two questions: 1) An evaluation of the overall comfort thanks to a scale with five steps from very uncomfortable to very comfortable and 2) A comparison with the classical MEG system thanks to a 5 steps scale from much less comfortable than the classical MEG system to much more comfortable.
Measured: 5 minutes after the end the recording session
Comfort of the subject during the MPO He4 recordings for volunteers through a short verbal questionary
The evaluation will be done verbally through a short questionary. This questionary evaluates the overall comfort of the MPO system with two questions: 1) An evaluation of the overall comfort thanks to a scale with five steps from very uncomfortable to very comfortable and 2) A comparison with the classical MEG system thanks to a 5 steps scale from much less comfortable than the classical MEG system to much more comfortable.
Measured: 5 minutes after the end of each recording session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal SubjectStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien JUNG, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615637
- Sponsor's protocol ID
- 69HCL20_0191
- Other IDs
- 2020-A00634-35
- Acronym
- NEW MEG
- Status last verified
- Feb 2021
- First submitted
- 8 Jul 2020
- Last updated
- 16 Feb 2021
- 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 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helium 4 Optically Pumped Magnetometers : a New Generation of Sensors for High Speed Functional Brain Imaging
- ClinicalTrials.gov ID
- NCT04615637
- Acronym / sponsor ID
- NEW MEG / 69HCL20_0191
- Keywords
- MEG, OPM, epilepsy, normal brain activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 4 Nov 2020 (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.
Our goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography sensors (OPM He4) to record brain magnetic activities. The investigator will record 1) normal subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) epileptic patient. The investigator will compare the signal to noise ratio of the normal or pathological activities between classical MEG sensors and our OPM He4 prototype.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensors | Experimental | Device: MEG recordingsAll subjects will follow the same experimental procedure: a recording using classical MEG followed by a recording in the same condition with the OPM He4 prototype. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age 18+
- Right handed
- Medical insurance
- Strongly motivated to participate to the study
- Signed informed consent for the study
Key exclusion criteria (14 listed)
- Age < 18 years or > 60
- Age < 18 years or > 60
- previous neurology or psychiatric pathologies except epilepsy
- Child bearing women
- Subject having one of the following mettalic parts :
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 |
|---|---|---|
| MEG recordings1. Classical MEG recordings (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli). 2. MEG recordings with our OPM He4 prototype (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli). | Device | Sensors |
Primary outcome
Signal to Noise Ratio of the recorded brain activities
Time frame: 1 month
Volunteers: The signal to noise ratio of normal brain activity following a stimulus will be computed with respect to the pre-stimulus baseline -100ms to -10 ms. Epileptic patient: The signal to noise ratio of abnormal epileptic brain activity will be computed with respect to a 100 ms baseline not containing any abnormal activity.
4 secondary outcomes
Signal to Noise Ratio of pre-frontal auditory activity
Time frame: one month
Signal to Noise Ratio of high frequency epileptic activity
Time frame: one month.
Comfort of the subject during the MPO He4 recordings for epileptic patient through a short verbal questionary
Time frame: 5 minutes after the end the recording session
Comfort of the subject during the MPO He4 recordings for volunteers through a short verbal questionary
Time frame: 5 minutes after the end of each recording session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- 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. This study is not recruiting at the moment.
Julien JUNG, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEG recordings in people with Normal Subject and Patient With Pharmaco-resistant Epilepsy, run by Hospices Civils de Lyon 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 17 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien JUNG, MD (04.72.35.79.00, julien.jung@chu-lyon.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 recorded brain activities (time frame: 1 month). 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 16 Feb 2021.