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
|Condition or disease||Intervention/treatment||Phase|
|Healthy Tetraplegia Locked-in Syndrome||Device: Stable and Independent Brain-computer Interfaces for Communication||Not Applicable|
|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|
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.
- 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.
- 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.
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
|Contact: Tomislav Milekovic, PhD||+41 (0) 22 379 42 03||Tomislav.Milekovic@unige.ch|
|University of Geneva, Campus Biotech||Recruiting|
|Geneva, Switzerland, 1202|
|Contact: Tomislav Milekovic, PhD +41 22 379 4203 email@example.com|