Clinical Validation Protocol for BCI for the Communication of Patients Suffering From Neuromuscular Disorders.

Communication Clinical Trial

— PVCAFM  

Official title:

Protocole de Validation Clinique du Logiciel d'Interface Cerveau-Ordinateur RoBIK Pour la Communication Des Patients Atteints de Maladie Neuromusculaires (MNM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284022
• Other study ID #: 14055
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: April 19, 2017
• Start date: October 2014
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication
• Neuromuscular Disease
• Neuromuscular Diseases

Intervention

Device:
• Brain computer interface
Recording the P300 Testing the device Using the device with a speller

Locations

Country	Name	City	State
France	Hôpital R. Poincaré	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Association Française contre les Myopathies (AFM), Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The comparison criteria for performance was the bitrate, br, that is defined by (Wolpow et al. 2000): ?br=log?_2 (M)+p.log_2 p+(1-p) ?log?_2 (1-p)/(M-1) where M=36 is the number of symbols p the spelling accuracy (the percentage of correctly identified symbols).	30 minutes
Secondary	patient satisfaction (visual analogic scale)		2 minutes