Status:

COMPLETED

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

Lead Sponsor:

Centre d'Investigation Clinique et Technologique 805

Collaborating Sponsors:

Association Française contre les Myopathies (AFM), Paris

Conditions:

Communication

Neuromuscular Disease

Eligibility:

All Genders

18+ years

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 tim...

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....

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2017

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT02284022

Start Date

October 1 2014

End Date

February 1 2017

Last Update

April 20 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hôpital R. Poincaré

Garches, France, 92380