- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03213561
Stable and Independent Communication Brain-computer Interfaces
March 26, 2020 updated by: Tomislav Milekovic
Stable and Independent Non-invasive Communication Brain-computer Interfaces Based on Error-adaptive Decoding Algorithms
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Geneva, Switzerland, 1202
- University of Geneva, Campus Biotech
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stable and Independent Communication Brain-computer Interfaces
Each arm will receive the same intervention.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain-computer interface stability
Time Frame: 3 years
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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.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2017
Primary Completion (Actual)
November 22, 2019
Study Completion (Actual)
November 22, 2019
Study Registration Dates
First Submitted
July 7, 2017
First Submitted That Met QC Criteria
July 7, 2017
First Posted (Actual)
July 11, 2017
Study Record Updates
Last Update Posted (Actual)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 26, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-00639
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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