Back to results

Stable and Independent Communication Brain-computer Interfaces

Primary Purpose

Healthy, Tetraplegia, Locked-in Syndrome

Status

Terminated

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Stable and Independent Brain-computer Interfaces for Communication

About this trial

This is an interventional supportive care trial for Healthy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Geneva, Campus Biotech

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stable and Independent Communication Brain-computer Interfaces

Arm Description

Each arm will receive the same intervention.

Outcomes

Primary Outcome Measures

Brain-computer interface stability

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

Brain-computer interface performance comparison

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.

Full Information

NCT ID

NCT03213561

First Posted

July 7, 2017

Last Updated

March 26, 2020

Sponsor

Tomislav Milekovic

Collaborators

University of Geneva, Switzerland, Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva, Wyss Center for Bio and Neuroengineering

1. Study Identification

Unique Protocol Identification Number

NCT03213561

Brief Title

Stable and Independent Communication Brain-computer Interfaces

Official Title

Stable and Independent Non-invasive Communication Brain-computer Interfaces Based on Error-adaptive Decoding Algorithms

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Terminated

Why Stopped

We have not succeeded in developing an approach that uses hdEEG to control a communication interface at an accuracy needed to complete the protocol.

Study Start Date

July 11, 2017 (Actual)

Primary Completion Date

November 22, 2019 (Actual)

Study Completion Date

November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tomislav Milekovic

Collaborators

University of Geneva, Switzerland, Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva, Wyss Center for Bio and Neuroengineering

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Tetraplegia, Locked-in Syndrome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stable and Independent Communication Brain-computer Interfaces

Arm Type

Experimental

Arm Description

Each arm will receive the same intervention.

Intervention Type

Device

Intervention Name(s)

Stable and Independent Brain-computer Interfaces for Communication

Intervention Description

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 Measure Information:

Title

Brain-computer interface stability

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Brain-computer interface performance comparison

Description

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.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

University of Geneva, Campus Biotech

City

Geneva

ZIP/Postal Code

1202

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Stable and Independent Communication Brain-computer Interfaces

We'll reach out to this number within 24 hrs