Clinical trial NCT03213561: Stable and Independent Communication Brain-computer Interfaces
Official title: Stable and Independent Non-invasive Communication Brain-computer Interfaces Based on Error-adaptive Decoding Algorithms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Tetraplegia
Locked-in Syndrome
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
name: Centre Hospitalier Universitaire Vaudois
name: University Hospital, Geneva
name: Wyss Center for Bio and Neuroengineering
First posted: 2017-07-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brain-computer interface stability
timeFrame: 3 years
Secondary outcomes:
measure: Brain-computer interface performance comparison
timeFrame: 3 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva, Campus Biotech
Study officials:
References: