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Stable and Independent Communication Brain-computer Interfaces

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ClinicalTrials.gov Identifier: NCT03213561
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
University of Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Wyss Center for Bio and Neuroengineering
Information provided by (Responsible Party):
Tomislav Milekovic, University of Geneva, Switzerland

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.

Condition or disease Intervention/treatment Phase
Healthy Tetraplegia Locked-in Syndrome Device: Stable and Independent Brain-computer Interfaces for Communication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Stable and Independent Non-invasive Communication Brain-computer Interfaces Based on Error-adaptive Decoding Algorithms
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Brain-computer interface stability [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Brain-computer interface performance comparison [ Time Frame: 3 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213561


Contacts
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Contact: Tomislav Milekovic, PhD +41 (0) 22 379 42 03 Tomislav.Milekovic@unige.ch

Locations
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Switzerland
University of Geneva, Campus Biotech Recruiting
Geneva, Switzerland, 1202
Contact: Tomislav Milekovic, PhD    +41 22 379 4203    tomislav.milekovic@unige.ch   
Sponsors and Collaborators
Tomislav Milekovic
University of Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Wyss Center for Bio and Neuroengineering

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Responsible Party: Tomislav Milekovic, Principal Investigator, University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT03213561     History of Changes
Other Study ID Numbers: 2017-00639
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms