Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)

• ClinicalTrials.gov Identifier: NCT01707498
• Recruitment Status: Unknown
• First Posted: October 16, 2012
• Last Update Posted: February 1, 2018
• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Collaborator: University of Versailles
• Information provided by (Responsible Party): david orlikowski, Centre d'Investigation Clinique et Technologique 805

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.

Condition or disease	Intervention/treatment	Phase
Quadraplegia	Procedure: Scanning device; Procedure: RoBIK Brain-Computer Interface	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients
• Actual Study Start Date: February 2013
• Estimated Primary Completion Date: January 2018
• Estimated Study Completion Date: January 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tetraplegic patients; Scanning device RoBIK Brain-Computer Interface	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.; Procedure: RoBIK Brain-Computer Interface; Patients will be asked to spell a text with the BCI
Experimental: Healthy volunteers; RoBIK Brain-Computer Interface	Procedure: RoBIK Brain-Computer Interface; Patients will be asked to spell a text with the BCI

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Installation time (seconds) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: DAVID ORLIKOWSKI, MD PHD; david.orlikowski@rpc.aphp.fr

Locations

France

Hopital Raymond Poincare; Recruiting

Garches, France, 92380

Contact: DAVID ORLIKOWSKI, MD PHD (33)147107777 david.orlikowski@rpc.aphp.fr

Contact: SANDRA POTTIER, CRA (33)147104469 sandra.pottier@rpc.aphp.fr

Principal Investigator: DAVID ORLIKOWSKI, MD PHD

Sub-Investigator: ERIC AZZABOU, MD

Sub-Investigator: CAROLINE HUGERON, MD

Sub-Investigator: PHILIPPE TRONCHET, MD

Sponsors and Collaborators

Centre d'Investigation Clinique et Technologique 805

University of Versailles

Investigators

• Study Director: LOUIS MAYAUD, ENGINEER; CIC IT 805

More Information

• Responsible Party: david orlikowski, PROFESSOR, Centre d'Investigation Clinique et Technologique 805
• ClinicalTrials.gov Identifier: NCT01707498
• Other Study ID Numbers: 2012-A00613-40
• First Posted: October 16, 2012
• Last Update Posted: February 1, 2018
• Last Verified: January 2018

Keywords provided by david orlikowski, Centre d'Investigation Clinique et Technologique 805:

BCI; TETRAPLEGIA; COMMUNICATION; P300; ASSISTIVE TECHNOLOGIE

Additional relevant MeSH terms:

Quadriplegia; Paralysis; Neurologic Manifestations; Nervous System Diseases