Amyotrophic Lateral SclerosisTECH-ICOPANCT04380649
Development and Test of a Headset for BCI Until Obtaining an Efficient and Comfortable System That Can be Used in Daily Practice by ALS People
A study testing New headset prototype in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
"Brain-computer interfaces (BCIs) are computer-based systems that acquire brain signals, analyze them, and translate them into commands that are relayed to an output device to carry out a desired action. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Spinal Cord Diseases
- What is being tested?
- New headset prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2023to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- For women of childbearing potential, use of contraception for the duration of the study
- Diagnosis of suspected ALS, possible, probable with ENMG, probable, defined according to the criteria of the World Federation of Neurology (revised El Escorial criteria, Airlie House Conference 1998)
- Understanding of the objective of the study after describing the principle of the P300 Speller and the course of the study
- Ability to follow the study procedure and to comply with the schedule of visits when entering the study
- Expression of a P300 wave under the conditions of the study
Who cannot join
- Psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures
- History of photosensitive epilepsy
- Patient subject to protective measures
- Non-correctable visual disturbances
- Limited ability to concentrate.
- Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
- Persons deprived of their liberty by a judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS
"Brain-computer interfaces (BCIs) are computer-based systems that acquire brain signals, analyze them, and translate them into commands that are relayed to an output device to carry out a desired action. BCIs represent a very active and promising field of research among devices for people with severe motor disabilities. As the currently available systems correspond to research prototypes, they are not adapted to daily live situations. On the other hand, some systems have recently been commercialized, principally for video games but they are not satisfactory for use as a substitute technology in disability.
A BCI's prototype for alternative communication using a virtual keyboard, the P300 Speller, has been developed by the National Institute for Research in Digital Science and Technology (Athena team - Nice University). This prototype includes an EEG-cap with gel based active electrodes. A recent study conducted on 20 patients with ALS (University Hospital, Nice) demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility. To achieve a system that can be used in daily live in severely disabled patients, technical developments are necessary.
Read more
The investigators have conceptualized and developed an ergonomic, comfortable, headset, including dry electrodes to allow a prolonged use of the system.
The purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved. This study is a monocentric usability study conducted on ALS people.
- Conditions
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Spinal Cord Diseases, Alternative Communication Devices, Neurodegenerative Diseases, Nervous System Diseases
- Being tested
- New headset prototype
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Spinal Cord Diseases, Neurodegenerative Diseases, Nervous System Diseases, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New headset prototypeDevice
creation of a new headset prototype for using the P300 Speller, comfortable to use in everyday life by people with disabilities.
| Study group | Role | What they receive |
|---|---|---|
| ALS people with severe disability | Experimental | Not described Receives: Device: New headset prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
prototype set-up time
The time for setting up the prototype will be defined in seconds by the time elapsed between the start and stop of the stopwatch, the installation sequence being defined as follows:
- start of the stopwatch: patient seated, equipment positioned on the table
- patient or caregiver (depending on the patient's motor skills; 1 person): takes the prototype and positions it on the (patient's) skull
- stopwatch stop: when the prototype is set up ready to operate
Measured: at 6 months
Quality of the impedance of each electrode
The quality will be considered satisfactory if the impedance value of each of the electrodes is ≤ 1 000 kOhm, according to literature data.
Measured: at 6 months
Number of errors during calibration
The number of errors in copying the 10 letters during the calibration phase will be counted.
Measured: at 6 months
Patient/caregiver satisfaction
The evaluation of patient and caregiver satisfaction will be carried out using visual analogue scales (VAS rated from 0 to 10) on their feelings (patient/caregiver) of use.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start13 Feb 2023
- Primary completion12 Aug 2024
- Study completion12 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380649
- Sponsor's protocol ID
- 19-PP-18
- Acronym
- TECH-ICOPA
- Status last verified
- Nov 2025
- First submitted
- 22 Apr 2020
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS
- ClinicalTrials.gov ID
- NCT04380649
- Acronym / sponsor ID
- TECH-ICOPA / 19-PP-18
- Conditions
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Spinal Cord Diseases, Alternative Communication Devices, Neurodegenerative Diseases, Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2026 (estimated)
- First posted
- 8 May 2020 (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.
"Brain-computer interfaces (BCIs) are computer-based systems that acquire brain signals, analyze them, and translate them into commands that are relayed to an output device to carry out a desired action. BCIs represent a very active and promising field of research among devices for people with severe motor disabilities. As the currently available systems correspond to research prototypes, they are not adapted to daily live situations. On the other hand, some systems have recently been commercialized, principally for video games but they are not satisfactory for use as a substitute technology in disability.
A BCI's prototype for alternative communication using a virtual keyboard, the P300 Speller, has been developed by the National Institute for Research in Digital Science and Technology (Athena team - Nice University). This prototype includes an EEG-cap with gel based active electrodes. A recent study conducted on 20 patients with ALS (University Hospital, Nice) demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility. To achieve a system that can be used in daily live in severely disabled patients, technical developments are necessary.
The investigators have conceptualized and developed an ergonomic, comfortable, headset, including dry electrodes to allow a prolonged use of the system.
The purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved. This study is a monocentric usability study conducted on ALS people.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALS people with severe disability | Experimental | Device: New headset prototype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- For women of childbearing potential, use of contraception for the duration of the study
- Diagnosis of suspected ALS, possible, probable with ENMG, probable, defined according to the criteria of the World Federation of Neurology (revised El Escorial criteria, Airlie House Conference 1998)
- Understanding of the objective of the study after describing the principle of the P300 Speller and the course of the study
- Ability to follow the study procedure and to comply with the schedule of visits when entering the study
Key exclusion criteria (7 listed)
- Psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures
- History of photosensitive epilepsy
- Patient subject to protective measures
- Non-correctable visual disturbances
- Limited ability to concentrate.
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 |
|---|---|---|
| New headset prototypecreation of a new headset prototype for using the P300 Speller, comfortable to use in everyday life by people with disabilities. | Device | ALS people with severe disability |
Primary outcome
prototype set-up time
Time frame: at 6 months
The time for setting up the prototype will be defined in seconds by the time elapsed between the start and stop of the stopwatch, the installation sequence being defined as follows: * start of the stopwatch: patient seated, equipment positioned on the table * patient or caregiver (depending on the patient's motor skills; 1 person): takes the prototype and positions it on the (patient's) skull * stopwatch stop: when the prototype is set up ready to operate
Quality of the impedance of each electrode
Time frame: at 6 months
The quality will be considered satisfactory if the impedance value of each of the electrodes is ≤ 1 000 kOhm, according to literature data.
Number of errors during calibration
Time frame: at 6 months
The number of errors in copying the 10 letters during the calibration phase will be counted.
Patient/caregiver satisfaction
Time frame: at 6 months
The evaluation of patient and caregiver satisfaction will be carried out using visual analogue scales (VAS rated from 0 to 10) on their feelings (patient/caregiver) of use.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- 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 New headset prototype in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
prototype set-up time (time frame: at 6 months). The study lists 4 primary outcomes in all. 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 26 Nov 2025.