Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)
Primary Purpose
Quadraplegia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scanning device
RoBIK Brain-Computer Interface
Sponsored by
About this trial
This is an interventional other trial for Quadraplegia focused on measuring BCI, TETRAPLEGIA, COMMUNICATION, P300, ASSISTIVE TECHNOLOGIE
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers:
- 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:
Healthy volunteers:
- 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
Sites / Locations
- Hopital Raymond PoincareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tetraplegic patients
Healthy volunteers
Arm Description
Scanning device RoBIK Brain-Computer Interface
RoBIK Brain-Computer Interface
Outcomes
Primary Outcome Measures
BIT RATE IN BIT PER MINUTE(bpm)
Bitrate (bpm): transfer of information from patient to computer in bits per minutes. This is a reference measurement to compare P300 speller Brain Computer Interfaces. It uses: number of choices on the interface (N), the average time to select one key (t) and the error rate (e)
Secondary Outcome Measures
Installation time (seconds)
Installation time (seconds), Number of caracters spelt in a pre-defined time, Error rate: Area Under the Receiver Operating Curve (AUROC), Balanced Error Rate (BER), Visual Analogous Scale for tiredness (before, after the use) and overall satisfaction.
Full Information
NCT ID
NCT01707498
First Posted
October 5, 2012
Last Updated
January 31, 2018
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
University of Versailles
1. Study Identification
Unique Protocol Identification Number
NCT01707498
Brief Title
Robust Intelligent Keyboard for Quadraplegic Patients
Acronym
PVCRoBIK
Official Title
Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
University of Versailles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is multi-center prospective randomized trial evaluating the effectiveness of a new brain-computer interface for communication of quadriplegic patients in a clinical context. This performance of this will compared to traditional assistive technology (scanning system) and to performance of a healthy volunteer population.
Detailed Description
The evaluation aims to estimate the performance of BCIs in patient and healthy subjects in a clinical setting (primary objective) and to compare this performance with an existing assitive technology adapted to the target population of this study (scanning system). A quadriplegic patient population (n = 10) evaluated the two techniques and a population of healthy subjects (n = 10) evaluated the BCI only.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadraplegia
Keywords
BCI, TETRAPLEGIA, COMMUNICATION, P300, ASSISTIVE TECHNOLOGIE
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tetraplegic patients
Arm Type
Experimental
Arm Description
Scanning device RoBIK Brain-Computer Interface
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
RoBIK Brain-Computer Interface
Intervention Type
Procedure
Intervention Name(s)
Scanning device
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
RoBIK Brain-Computer Interface
Intervention Description
Patients will be asked to spell a text with the BCI
Primary Outcome Measure Information:
Title
BIT RATE IN BIT PER MINUTE(bpm)
Description
Bitrate (bpm): transfer of information from patient to computer in bits per minutes. This is a reference measurement to compare P300 speller Brain Computer Interfaces. It uses: number of choices on the interface (N), the average time to select one key (t) and the error rate (e)
Time Frame
15 MINUTES
Secondary Outcome Measure Information:
Title
Installation time (seconds)
Description
Installation time (seconds), Number of caracters spelt in a pre-defined time, Error rate: Area Under the Receiver Operating Curve (AUROC), Balanced Error Rate (BER), Visual Analogous Scale for tiredness (before, after the use) and overall satisfaction.
Time Frame
60 mns
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers:
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:
Healthy volunteers:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DAVID ORLIKOWSKI, MD PHD
Email
david.orlikowski@rpc.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOUIS MAYAUD, ENGINEER
Organizational Affiliation
CIC IT 805
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DAVID ORLIKOWSKI, MD PHD
Phone
(33)147107777
Email
david.orlikowski@rpc.aphp.fr
First Name & Middle Initial & Last Name & Degree
SANDRA POTTIER, CRA
Phone
(33)147104469
Email
sandra.pottier@rpc.aphp.fr
First Name & Middle Initial & Last Name & Degree
DAVID ORLIKOWSKI, MD PHD
First Name & Middle Initial & Last Name & Degree
ERIC AZZABOU, MD
First Name & Middle Initial & Last Name & Degree
CAROLINE HUGERON, MD
First Name & Middle Initial & Last Name & Degree
PHILIPPE TRONCHET, MD
12. IPD Sharing Statement
Learn more about this trial
Robust Intelligent Keyboard for Quadraplegic Patients
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