Stable and Independent Communication Brain-computer Interfaces

Not Applicable

Terminated

• Conditions: Healthy; Tetraplegia; Locked-in Syndrome
• Interventions: Device: Stable and Independent Brain-computer Interfaces for Communication

• Registration Number: NCT03213561
• Lead Sponsor: Tomislav Milekovic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-07
• Study Start: 2017-07-11
• Study First Posted: 2017-07-11
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stable and Independent Communication Brain-computer Interfaces	Stable and Independent Brain-computer Interfaces for Communication	Each arm will receive the same intervention.

Primary Outcome Measures

Name	Time	Method
Brain-computer interface stability	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

Name	Time	Method
Brain-computer interface performance comparison	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.

Trial Locations

Locations (1)

University of Geneva, Campus Biotech; 🇨🇭 Geneva, Switzerland