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Completed

NCT Number: NCT02284022

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital R. Poincaré

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Computer Interface

Device

Recording the P300 Testing the device Using the device with a speller

Primary outcomes

  1. 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.

    Time frame: 30 minutes

    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).

Secondary outcomes

  1. patient satisfaction (visual analogic scale)

    Time frame: 2 minutes

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • Association Française contre les Myopathies (AFM), Paris

Registry information

Official study title

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

Acronym: PVCAFM

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2014
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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