Healthy VolunteersMAP-EFNINCT02790411
Adjustment Exploratory Protocols and Functional Evaluation of New Non Invasive Devices in Healthy Volunteers
A study testing Imaging devices and New Non Invasive Devices in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Imaging devices and New Non Invasive Devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2013to 21 May 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Male or female aged over 18 years
- Registered in the French social security scheme
- Signed informed consent
Who cannot join
- Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
- Contraindication to Magnetic resonance imaging (MRI)
- All categories of protected persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjustment Exploratory Protocols (MagnetoEncephaloGraphy Study : MEG, ElectroEncephaloGram : EEG, Magnetic Resonance Imaging : MRI, Functional MRI : MRIf, Motor Platform) and Functional Evaluation of New Non Invasive Devices (REX BIONICS Exoskeleton) in Healthy Volunteers
Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement.
Read the detailed description
Various tests are needed for methodological optimization of the several devices (per-operative MRI, MEG, EEG, SPECT-CT, motor platform) of the technological platform.
- Conditions
- Healthy Volunteers
- Being tested
- Imaging devices, New Non Invasive Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging devicesDevice
technological adjustment tests
New Non Invasive DevicesDevice
Tests with REX BIONICS Exoskeleton
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Imaging devices New Non Invasive Devices Receives: Device: Imaging devices; Device: New Non Invasive Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic brain activity
MEG records
Measured: 2 hours
Brain imaging
MRI and SPECT-CT records
Measured: 2 hours
Electrical brain activity
EEG records
Measured: 2 hours
Motor activity parameters
Motor platform records
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start21 May 2013
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790411
- Sponsor's protocol ID
- MAP-EFNI
- Acronym
- MAP-EFNI
- Status last verified
- Nov 2022
- First submitted
- 12 May 2016
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustment Exploratory Protocols (MagnetoEncephaloGraphy Study : MEG, ElectroEncephaloGram : EEG, Magnetic Resonance Imaging : MRI, Functional MRI : MRIf, Motor Platform) and Functional Evaluation of New Non Invasive Devices (REX BIONICS Exoskeleton) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02790411
- Acronym / sponsor ID
- MAP-EFNI / MAP-EFNI
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 21 May 2013 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 3 Jun 2016 (estimated)
- 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.
Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement.
Detailed description
Various tests are needed for methodological optimization of the several devices (per-operative MRI, MEG, EEG, SPECT-CT, motor platform) of the technological platform.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Device: Imaging devices, Device: New Non Invasive DevicesImaging devices New Non Invasive Devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Male or female aged over 18 years
- Registered in the French social security scheme
- Signed informed consent
Key exclusion criteria (3 listed)
- Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
- Contraindication to Magnetic resonance imaging (MRI)
- All categories of protected persons
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 |
|---|---|---|
| Imaging devicestechnological adjustment tests | Device | healthy volunteers |
| New Non Invasive DevicesTests with REX BIONICS Exoskeleton | Device | healthy volunteers |
Primary outcome
Magnetic brain activity
Time frame: 2 hours
MEG records
Brain imaging
Time frame: 2 hours
MRI and SPECT-CT records
Electrical brain activity
Time frame: 2 hours
EEG records
Motor activity parameters
Time frame: 2 hours
Motor platform records
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging devices and New Non Invasive Devices in people with Healthy Volunteers, run by University Hospital, Grenoble 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic brain activity (time frame: 2 hours). The study lists 4 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 14 Nov 2022.