Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2013-02-28
2018-01-31
Brief Summary
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Detailed Description
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When a subject meets all the eligibility criteria and is not discarded by any non-inclusion criteria, he is included in the study. The order of the two techniques to be compared is randomized.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Tetraplegic patients
Scanning device RoBIK Brain-Computer Interface
Scanning device
Patients will be asked to spell a text with a specific scanning device. The most appropriate contactor or clicking device will be chosen by a senior therapist.
RoBIK Brain-Computer Interface
Patients will be asked to spell a text with the BCI
Healthy volunteers
RoBIK Brain-Computer Interface
RoBIK Brain-Computer Interface
Patients will be asked to spell a text with the BCI
Interventions
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Scanning device
Patients will be asked to spell a text with a specific scanning device. The most appropriate contactor or clicking device will be chosen by a senior therapist.
RoBIK Brain-Computer Interface
Patients will be asked to spell a text with the BCI
Eligibility Criteria
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Inclusion Criteria
* Informed consent
* Adults aged more than 18yo
* Passed complete medical check-up (heart-rate, blood pressure,...)
* Negative pregnancy test
Quadripleagic patients:
* Informed consent
* Adults aged more than 18years
* Passed medical exam
* Negative pregnancy test
* Full medical checkup
* haemodynamic stability
Exclusion Criteria
* history of epilepsy or seizure
* auditory or visual deficit
* atopic scalp dermatitis
* hypersensitivity to gold
* curator/guardianship/under protection of judicial authority
* unable to understand the information note and/or to cooperate
* no social security
* can't read
Quadripleagic patients:
* history of epilepsy or seizure
* auditory or visual deficit
* cerebral lesion
* atopic scalp dermatitis
* hypersensitivity to gold
* curator/guardianship/under protection of judicial authority
* unable to understand the information note and/or to cooperate
* no social security
* can't read
* included in a different clinical trial with exclusion period
18 Years
ALL
Yes
Sponsors
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University of Versailles
OTHER
Centre d'Investigation Clinique et Technologique 805
OTHER
Responsible Party
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david orlikowski
PROFESSOR
Principal Investigators
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LOUIS MAYAUD, ENGINEER
Role: STUDY_DIRECTOR
CIC IT 805
Locations
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Hopital Raymond Poincare
Garches, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2012-A00613-40
Identifier Type: -
Identifier Source: org_study_id
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