Amyotrophic Lateral SclerosisNCT01897818
Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
A study testing communication system P300 Speller in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- communication system P300 Speller
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jul 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 18
- have a diagnosis of ALS suspected, possible, probable with EMG
- be able to follow the study process and to comply with the schedule of visits upon entry into the study
- understand the purpose of the study
- expressing P300 wave in the conditions of the study
Who cannot join
- have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study
- have a significant history of photosensitive epilepsy
- have a history of allergy to the gel used for the electrodes
- Major protected by law (guardianship, curators)
- have uncorrectable visual disorders
- not being able to maintain a sitting position and focus on a computer screen for more than 30 min.
Trial locations and contacts
1 site in 1 country.
Claude DESNUELLE, Pr contact
France1 site, 1 recruiting
- Recruiting
Hôpital de l'Archet I
Nice, 06202
Claude DESNUELLE, Pr, desnuelle.c@chu-nice.fr
Claude DESNUELLE, Pr
About this study
ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- communication system P300 Speller
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication system P300 SpellerDevice
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Experimental | Not described Receives: Device: communication system P300 Speller |
What is being measured
The primary outcome is the main question the study is designed to answer.
the full achievement of "copy spelling" and "free spelling" tests session 1
Measured: 14 days after inclusion
the full achievement of "copy spelling" and "free spelling" tests session 2
Measured: 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2015 (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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT01897818
- Sponsor's protocol ID
- 12-PP-16
- Status last verified
- May 2013
- First submitted
- 9 Jul 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
- ClinicalTrials.gov ID
- NCT01897818
- Acronym / sponsor ID
- 12-PP-16
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (estimated)
- First posted
- 12 Jul 2013 (estimated)
- 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.
ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALS patients | Experimental | Device: communication system P300 Speller |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >= 18
- have a diagnosis of ALS suspected, possible, probable with EMG
- be able to follow the study process and to comply with the schedule of visits upon entry into the study
- understand the purpose of the study
- expressing P300 wave in the conditions of the study
Key exclusion criteria (6 listed)
- have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study
- have a significant history of photosensitive epilepsy
- have a history of allergy to the gel used for the electrodes
- Major protected by law (guardianship, curators)
- have uncorrectable visual disorders
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 |
|---|---|---|
| communication system P300 Speller | Device | ALS patients |
Primary outcome
the full achievement of "copy spelling" and "free spelling" tests session 1
Time frame: 14 days after inclusion
the full achievement of "copy spelling" and "free spelling" tests session 2
Time frame: 28 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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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.
Claude DESNUELLE, Pr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication system P300 Speller in people with Amyotrophic Lateral Sclerosis, 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jul 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claude DESNUELLE, Pr (desnuelle.c@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the full achievement of "copy spelling" and "free spelling" tests session 1 (time frame: 14 days after inclusion). The study lists 2 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 12 Jul 2013.