Stable and Independent Communication Brain-computer Interfaces

Stable and Independent Non-invasive Communication Brain-computer Interfaces Based on Error-adaptive Decoding Algorithms

People with locked-in syndrome cannot move their limbs or talk because of a motor impairment, but remain conscious and intellectually awake. Restoring the ability to communicate to people with locked-in syndrome will have a positive effect on their quality of life, will enable them to reintegrate into society and increase their capacity to lead productive and fulfilling lives. This study sims to develop a new assisted communication device based on a brain-computer interface, a system that allows the user to control a computer with his brain activity. The investigators will develop this brain-computer system for long-term stability and independent use by using adaptive decoders. The investigators will test the long-term stability and independence of this system with healthy volunteers, people with tetraplegia and people with locked-in syndrome over time periods of several months.

Study Overview

• Status: Terminated
• Conditions: Healthy; Tetraplegia; Locked-in Syndrome
• Intervention / Treatment: Device: Stable and Independent Brain-computer Interfaces for Communication

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1202
    • University of Geneva, Campus Biotech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria for healthy persons:

• Older than 18
• Fluent in French, English, German or Italian
• Good visual acuity

Inclusion criteria for people with tetraplegia:

• Older than 18
• Fluent in French, English, German or Italian
• Good visual acuity
• Diagnosed with spinal cord injury, brainstem stroke, spinal stroke, muscular dystrophy or other non-degenerative motor neuron disorders
• Limited or no ability to use both hands - less than grade 4 muscle strength in elbow extension and wrist extension and less than grade 2 strength in finger flexor and abduction on both sides

Inclusion criteria for people with locked-in syndrome:

• Were fluent in French, English, German or Italian before losing the ability to speak
• Enough visual capability to see large letters from a distance of around 50cm according to caretaker's or guardian's opinion

Exclusion criteria for healthy persons:

• Smokers
• Substance or alcohol abuse
• Neurological or psychiatric illness
• History of cranio-facial surgery
• Metallic implants that would prohibit the subject from having a MRI scan
• Medications that may retard motor coordination and cognitive ability (such as sedatives)
• Seizure disorders
• Treated with anti-epileptic medications

Exclusion criteria for people with tetraplegia and locked-in syndrome:

• Disabling neurological illness other than tetraplegia or locked-in syndrome
• Disabling psychiatric illness
• History of cranio-facial surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stable and Independent Communication Brain-computer Interfaces; Each arm will receive the same intervention.

Device: Stable and Independent Brain-computer Interfaces for Communication; The participants will perform an MRI head scan, which the investigators will use to construct 3D head models of participants. The investigators will use these modele to reconstruct the activity of brain sources from EEG signals. The participants will then take part in a series of EEG recording sessions. During the initial "calibration" sessions, the participants will react with real or attempted movements to visual cues. The investigators will use the EEG signals from these sessions to calibrate the text-entry interface used in the validation sessions that follow. During the validation sessions, the participants will control the text-entry interface to write messages using their EEG signals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain-computer interface stability	The investigators will measure the text-entry rate achieved using the brain-computer interface in each session by the number of correct characters per minute (CCPM). At the end of the study, the investigators will calculate the average brain-computer interface performance, and the correlation between the performance and the duration of brain-computer interface use (performance-use correlation). Brain-computer interface stability will be established if the performance-use correlation is greater than -0.5 CCPM/year. Primary objective of the study will be met if the brain-computer interface performance is stable for 75% of participants or more in each of three study populations, and if the average brain-computer interface performance for participants that show stable performance is greater than 5 CCPM.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain-computer interface performance comparison	At the end of the study, the investigators will compare the brain-computer interface performance and the performance-use correlation between the three study populations.	3 years

Collaborators and Investigators

• Sponsor: Tomislav Milekovic
• Collaborators: University Hospital, Geneva; Centre Hospitalier Universitaire Vaudois; Wyss Center for Bio and Neuroengineering; University of Geneva, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Paralysis; Quadriplegia; Locked-In Syndrome
• Other Study ID Numbers: 2017-00639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No