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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Switzerland
      • Geneva, Switzerland, 1202
        • University of Geneva, Campus Biotech

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tomislav Milekovic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
Centre Hospitalier Universitaire Vaudois
Wyss Center for Bio and Neuroengineering
University of Geneva, Switzerland

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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