Functional Brain MappingPhase 1TAPFINGERNCT02574026
Tapfinger Psychomotor Target
A Phase 1 study testing Psychomotor tasks in people with Functional Brain Mapping, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal volunteers by tapping the finger . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Brain Mapping
- What is being tested?
- Psychomotor tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2010to 31 Jul 2020
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female between 18 and 70 years
- Informed consent
- Benefiting from Social Security
- French or english speaking, to understand study procedure
- Tetraplegic patients : traumatic injury of the cervical spine with retained respiratory autonomy and without associated head injury
Who cannot join
- Contra-indication to MRI
- Claustrophobia
- Mental disorders
- Pregancy
- All categories of protected persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MagnetoEncephaloGraphy Study of Cerebral Activations Induced by Psychomotor Tasks for Target Localisation in View of BCI Clinical Trial
The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal volunteers by tapping the finger .
Read the detailed description
Normal healthy (20) volunteers and tetraplegic patients(10) will be submitted to the temporo-spatial mapping of their brain activity, both sensory and motor, induced by a simple behavioral task, consisting on tapping with the finger on a detection pad. This will be done in a light and then dark environment, on a rythm spontaneous and then paced by sound bips. Accelerometric recording will provide the three dimensionnal displacements of the finger as well as the time code.
Brain activity is simultaneously recorded using MEG (306 channels) and EEG (64 channels. Data will be processed by an INPLS algorithm to detect the predictors of activity, their location and time-course.
3D mapping data will be matched with the patient's anatomy provided by 1.5T MRI previously performed.
The aim of the study is to prepare the strategy of implantation of multielectrodes ECoG implants to restore motility in tetraplegic patients in a human BCI protocol currently under development.
- Conditions
- Functional Brain Mapping
- Being tested
- Psychomotor tasks
- Keywords
- MEG, EEG, MRI, Brain mapping, functional imaging, brain computer interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychomotor tasksBehavioural
the acquisition of data will be performed in one unique session no drug administration no surgery
| Study group | Role | What they receive |
|---|---|---|
| Psychomotor tasks | Experimental | 20 healthy subjects and 10 tetraplegic patients will participate to acquisition of MEG, EEG, MRI data during a motor tasks Receives: Behavioral: Psychomotor tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEG records for functional brain mapping
This study is not a therapeutic clinical study. No treatment is being delivered.
Measured: one hour study
Secondary outcomes (2)
MEG measurements during psychomotor tasks
MEG records induced by finger tapping will be performed either randomly or following sound bips pacing.
Measured: one hour study
EEG measurements during psychomotor tasks
EEG records induced by finger tapping will be performed either randomly or following sound bips pacing.
Measured: one hour study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startAug 2010
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Brain MappingStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Responsible party
- Sponsor
- Investigators
- Alim L Benabid, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574026
- Sponsor's protocol ID
- 2010-A00421-38
- Acronym
- TAPFINGER
- Status last verified
- May 2022
- First submitted
- 5 Oct 2015
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MagnetoEncephaloGraphy Study of Cerebral Activations Induced by Psychomotor Tasks for Target Localisation in View of BCI Clinical Trial
- ClinicalTrials.gov ID
- NCT02574026
- Acronym / sponsor ID
- TAPFINGER / 2010-A00421-38
- Conditions
- Functional Brain Mapping
- Keywords
- MEG, EEG, MRI, Brain mapping, functional imaging, brain computer interface
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Study start
- Aug 2010
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 Oct 2015 (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.
The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal volunteers by tapping the finger .
Detailed description
Normal healthy (20) volunteers and tetraplegic patients(10) will be submitted to the temporo-spatial mapping of their brain activity, both sensory and motor, induced by a simple behavioral task, consisting on tapping with the finger on a detection pad. This will be done in a light and then dark environment, on a rythm spontaneous and then paced by sound bips. Accelerometric recording will provide the three dimensionnal displacements of the finger as well as the time code.
Brain activity is simultaneously recorded using MEG (306 channels) and EEG (64 channels. Data will be processed by an INPLS algorithm to detect the predictors of activity, their location and time-course.
3D mapping data will be matched with the patient's anatomy provided by 1.5T MRI previously performed.
The aim of the study is to prepare the strategy of implantation of multielectrodes ECoG implants to restore motility in tetraplegic patients in a human BCI protocol currently under development.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychomotor tasks | Experimental | Behavioral: Psychomotor tasks20 healthy subjects and 10 tetraplegic patients will participate to acquisition of MEG, EEG, MRI data during a motor tasks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female between 18 and 70 years
- Informed consent
- Benefiting from Social Security
- French or english speaking, to understand study procedure
- Tetraplegic patients : traumatic injury of the cervical spine with retained respiratory autonomy and without associated head injury
Key exclusion criteria (5 listed)
- Contra-indication to MRI
- Claustrophobia
- Mental disorders
- Pregancy
- 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 |
|---|---|---|
| Psychomotor tasksthe acquisition of data will be performed in one unique session no drug administration no surgery | Behavioural | Psychomotor tasks |
Primary outcome
MEG records for functional brain mapping
Time frame: one hour study
This study is not a therapeutic clinical study. No treatment is being delivered.
2 secondary outcomes
MEG measurements during psychomotor tasks
Time frame: one hour study
EEG measurements during psychomotor tasks
Time frame: one hour study
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 24 May 2022.
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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.
Alim L Benabid, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psychomotor tasks in people with Functional Brain Mapping, 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 5 inclusion and 5 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 24 May 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MEG records for functional brain mapping (time frame: one hour study). 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 24 May 2022.