HealthyNCT03213561
Stable and Independent Communication Brain-computer Interfaces
A study testing Stable and Independent Brain-computer Interfaces for Communication in people with Healthy and Tetraplegia, run by Tomislav Milekovic at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Tetraplegia, Locked-in Syndrome
- What is being tested?
- Stable and Independent Brain-computer Interfaces for Communication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jul 2017to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18
- Fluent in French, English, German or Italian
- Good visual acuity
- Older than 18
- Fluent in French, English, German or Italian
- Good visual acuity
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- 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
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy, Tetraplegia, Locked-in Syndrome
- Being tested
- Stable and Independent Brain-computer Interfaces for Communication
- Medical subject headings
- Quadriplegia, Locked-In Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable and Independent Brain-computer Interfaces for CommunicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Stable and Independent Communication Brain-computer Interfaces | Experimental | Each arm will receive the same intervention. Receives: Device: Stable and Independent Brain-computer Interfaces for Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start11 Jul 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomislav Milekovic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva, Wyss Center for Bio and Neuroengineering
- Responsible party
- Sponsor-investigator, Tomislav Milekovic, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213561
- Sponsor's protocol ID
- 2017-00639
- Other IDs
- 2017
- Status last verified
- Mar 2020
- First submitted
- 7 Jul 2017
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stable and Independent Non-invasive Communication Brain-computer Interfaces Based on Error-adaptive Decoding Algorithms
- ClinicalTrials.gov ID
- NCT03213561
- Acronym / sponsor ID
- 2017-00639
- Conditions
- Healthy, Tetraplegia, Locked-in Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tomislav MilekovicUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland, Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva, Wyss Center for Bio and Neuroengineering
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable and Independent Communication Brain-computer Interfaces | Experimental | Device: Stable and Independent Brain-computer Interfaces for CommunicationEach arm will receive the same intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Older than 18
- Fluent in French, English, German or Italian
- Good visual acuity
- Older than 18
- Fluent in French, English, German or Italian
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable and Independent Brain-computer Interfaces for CommunicationThe 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. | Device | Stable and Independent Communication Brain-computer Interfaces |
Primary outcome
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.
1 secondary outcome
Brain-computer interface performance comparison
Time frame: 3 years
Results and safety
The study was stopped early (reason given: We have not succeeded in developing an approach that uses hdEEG to control a communication interface at an accuracy needed to complete the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stable and Independent Brain-computer Interfaces for Communication in people with Healthy and Tetraplegia, run by Tomislav Milekovic at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We have not succeeded in developing an approach that uses hdEEG to control a communication interface at an accuracy needed to complete the protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain-computer interface stability (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.