Stable and Independent Communication Brain-computer Interfaces

NCT ID: NCT03213561

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2019-11-22

Brief Summary

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.

Conditions

Healthy; Tetraplegia; Locked-in Syndrome

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stable and Independent Communication Brain-computer Interfaces

Each arm will receive the same intervention.

Group Type: EXPERIMENTAL

Stable and Independent Brain-computer Interfaces for Communication

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Geneva, Switzerland

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Wyss Center for Bio and Neuroengineering

OTHER

Sponsor Role: collaborator

Tomislav Milekovic

OTHER

Sponsor Role: lead

Responsible Party

Tomislav Milekovic

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Geneva, Campus Biotech

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2017-00639

Identifier Type: -

Identifier Source: org_study_id