Robust Intelligent Keyboard for Quadraplegic Patients

Quadraplegia Clinical Trial

— PVCRoBIK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01707498
• Other study ID #: 2012-A00613-40
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2012
• Last updated: January 31, 2018
• Start date: February 2013
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: DAVID ORLIKOWSKI, MD PHD
• Email: david.orlikowski[@]rpc.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quadraplegia
• Quadriplegia

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	University of Versailles

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	15 MINUTES
Secondary	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.	60 mns