Clinical trial NCT02284022: Clinical Validation Protocol for BCI for the Communication of Patients Suffering From Neuromuscular Disorders.
Official title: Protocole de Validation Clinique du Logiciel d'Interface Cerveau-Ordinateur RoBIK Pour la Communication Des Patients Atteints de Maladie Neuromusculaires (MNM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Communication
Neuromuscular Disease
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Association Française contre les Myopathies (AFM), Paris
First posted: 2014-11-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: neuromuscular disease patients

Brief summary: the objective of this protocol is evaluate the safety and tolerance of a communication system for severely disable patients with myopathies. The system analyses the brain electric activity in real time and converts it into digital commands for a spelling device, which is refered to as the P300 speller in the scientific literature. The secondary objective is to compare the performance of such tool with a more traditional assistive technology for the communication of severely disabled patients : scanner systems.

Detailed description: This is a pilot study for which 15 patients with myopathies will be included. The primary objective of the study is to assess the safety and tolerance of a system for communication named P300 speller. The P3Speller is a brain computer interface (BCI) that records the brain electric activity with the use of electroencephalography (EEG) and analyzes it in real time in order to identify slight changes generated in relation to a visual stimulation (evoked potentials). The identification of such brain potentials is translated into a digital command for a spelling device. The secondary objective of this study is to compare the efficacy of this spelling device with a more traditional assisitve technology called scanner interface. A scanner interface uses single clicks that can be obtaines with an adequate interface which exploits the remaining muscular activity from a patients.

Every patient will use each interface (P300 sepller and Scanning) with a randomized order. Results will bec o,pared in terms of information flow from the patient to the computer expressed in bit rate per minute.

Eligibility criteria: Inclusion Criteria:

* Adult older than 18y.o., diagnosed with neuromuscular disease, stable vital signs and informed consent

Exclusion Criteria:

* History of seizure, brain damage, sight or auditory dysfunction, Atopic dermatitis, skin hypersensitivity to gold, patient under guardianship, illiterates or not able to cooperate , cognitive dysfunction
* Steinert disease, Merosine negative disease, Alpha-dystroglycanopathies

Primary outcomes:
measure: Bit rate (BR) the amount fo information that flows from the patient to the computer during the spelling session. This criterion is a combination of the number of symbols selected, the accuracy, and the time.
timeFrame: 30 minutes
Secondary outcomes:
measure: patient satisfaction (visual analogic scale)
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital R. Poincaré
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: David Orlikowski, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: