Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Quadraplegia
- Sponsor
- Centre d'Investigation Clinique et Technologique 805
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- BIT RATE IN BIT PER MINUTE(bpm)
- Last Updated
- 8 years ago
Overview
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.
Investigators
david orlikowski
PROFESSOR
Centre d'Investigation Clinique et Technologique 805
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
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:
Outcomes
Primary Outcomes
BIT RATE IN BIT PER MINUTE(bpm)
Time Frame: 15 MINUTES
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 Outcomes
- Installation time (seconds)(60 mns)