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

NCT02284022 | Completed

• 1 other identifier: 14055
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Communication; Neuromuscular Disease

Outcome Measures

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.

  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 Outcomes (1)

• patient satisfaction (visual analogic scale)

  2 minutes

Study Arms (1)

Brain Computer Interface

Patients will test the brain computer interface system

Device: Brain computer interface

Interventions

Brain computer interface DEVICE

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

Brain Computer Interface

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

neuromuscular disease patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead
• Association Française contre les Myopathies (AFM), Paris: collaborator

Study Sites (1)

Hôpital R. Poincaré

Garches, 92380, France

Location

MeSH Terms

Conditions

Communication; Neuromuscular Diseases

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Behavior; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• David Orlikowski, MDPhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

FR (1)