Robust Intelligent Keyboard for Quadraplegic Patients

Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707498

Acronym

PVCRoBIK

Enrollment

Registered

2012-10-16

Start date

2013-02-28

Completion date

2018-01-31

Last updated

2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quadraplegia

Keywords

BCI, TETRAPLEGIA, COMMUNICATION, P300, ASSISTIVE TECHNOLOGIE

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.

Interventions

PROCEDUREScanning 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.

PROCEDURERoBIK Brain-Computer Interface

Patients will be asked to spell a text with the BCI

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
BIT RATE IN BIT PER MINUTE(bpm)	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

Measure	Time frame	Description
Installation time (seconds)	60 mns	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.

Countries

France

Contacts

Primary ContactDAVID ORLIKOWSKI, MD PHD

david.orlikowski@rpc.aphp.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026