Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)

Centre d'Investigation Clinique et Technologique 805

Status: Unknown

Conditions: Quadraplegia

Treatments: Procedure: Scanning device; Procedure: RoBIK Brain-Computer Interface

Study type: Interventional

Funder types: Other

Identifiers

NCT01707498

2012-A00613-40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Tetraplegic patients

Experimental group

Description:

Scanning device RoBIK Brain-Computer Interface

Treatment:

Procedure: RoBIK Brain-Computer Interface

Procedure: Scanning device

Healthy volunteers

Experimental group

Description:

RoBIK Brain-Computer Interface

Treatment:

Procedure: RoBIK Brain-Computer Interface