CommunicationPVCAFMNCT02284022
Clinical Validation Protocol for BCI for the Communication of Patients Suffering From Neuromuscular Disorders.
An observational study of Communication and Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
the objective of this protocol is evaluate the safety and tolerance of a communication system for severely disable patients with myopathies. The system analyses the brain electric activity in real time and converts it into digital commands for a spelling device, which is refered to as the P300 speller in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Neuromuscular Disease
- What is being tested?
- Brain computer interface
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Feb 2017
- Phase
- Observational
- 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
Study population: neuromuscular disease patients
Who may be able to join
- Adult older than 18y.o., diagnosed with neuromuscular disease, stable vital signs and informed consent
Who cannot join
- History of seizure, brain damage, sight or auditory dysfunction, Atopic dermatitis, skin hypersensitivity to gold, patient under guardianship, illiterates or not able to cooperate , cognitive dysfunction
- Steinert disease, Merosine negative disease, Alpha-dystroglycanopathies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocole de Validation Clinique du Logiciel d'Interface Cerveau-Ordinateur RoBIK Pour la Communication Des Patients Atteints de Maladie Neuromusculaires (MNM)
the objective of this protocol is evaluate the safety and tolerance of a communication system for severely disable patients with myopathies. The system analyses the brain electric activity in real time and converts it into digital commands for a spelling device, which is refered to as the P300 speller in the scientific literature. The secondary objective is to compare the performance of such tool with a more traditional assistive technology for the communication of severely disabled patients : scanner systems.
Read the detailed description
This is a pilot study for which 15 patients with myopathies will be included. The primary objective of the study is to assess the safety and tolerance of a system for communication named P300 speller. The P3Speller is a brain computer interface (BCI) that records the brain electric activity with the use of electroencephalography (EEG) and analyzes it in real time in order to identify slight changes generated in relation to a visual stimulation (evoked potentials). The identification of such brain potentials is translated into a digital command for a spelling device. The secondary objective of this study is to compare the efficacy of this spelling device with a more traditional assisitve technology called scanner interface. A scanner interface uses single clicks that can be obtaines with an adequate interface which exploits the remaining muscular activity from a patients.
Every patient will use each interface (P300 sepller and Scanning) with a randomized order. Results will bec o,pared in terms of information flow from the patient to the computer expressed in bit rate per minute.
- Conditions
- Communication, Neuromuscular Disease
- Being tested
- Brain computer interface
- Medical subject headings
- Communication, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain computer interfaceDevice
Recording the P300 Testing the device Using the device with a speller
| Study group | Role | What they receive |
|---|---|---|
| Brain Computer Interface | Patients will test the brain computer interface system Receives: Device: Brain computer interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bit rate (BR) the amount fo information that flows from the patient to the computer during the spelling session. This criterion is a combination of the number of symbols selected, the accuracy, and the time.
The comparison criteria for performance was the bitrate, br, that is defined by (Wolpow et al. 2000):
〖br=log〗_2 (M)+p.log_2 p+(1-p) 〖log〗_2 (1-p)/(M-1) where M=36 is the number of symbols p the spelling accuracy (the percentage of correctly identified symbols).
Measured: 30 minutes
Secondary outcomes (1)
patient satisfaction (visual analogic scale)
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris
- Responsible party
- Sponsor
- Investigators
- David Orlikowski, MDPhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284022
- Sponsor's protocol ID
- 14055
- Acronym
- PVCAFM
- Status last verified
- Apr 2017
- First submitted
- 3 Nov 2014
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocole de Validation Clinique du Logiciel d'Interface Cerveau-Ordinateur RoBIK Pour la Communication Des Patients Atteints de Maladie Neuromusculaires (MNM)
- ClinicalTrials.gov ID
- NCT02284022
- Acronym / sponsor ID
- PVCAFM / 14055
- Conditions
- Communication, Neuromuscular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Association Française contre les Myopathies (AFM), Paris
- Study start
- Oct 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Nov 2014 (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.
the objective of this protocol is evaluate the safety and tolerance of a communication system for severely disable patients with myopathies. The system analyses the brain electric activity in real time and converts it into digital commands for a spelling device, which is refered to as the P300 speller in the scientific literature. The secondary objective is to compare the performance of such tool with a more traditional assistive technology for the communication of severely disabled patients : scanner systems.
Detailed description
This is a pilot study for which 15 patients with myopathies will be included. The primary objective of the study is to assess the safety and tolerance of a system for communication named P300 speller. The P3Speller is a brain computer interface (BCI) that records the brain electric activity with the use of electroencephalography (EEG) and analyzes it in real time in order to identify slight changes generated in relation to a visual stimulation (evoked potentials). The identification of such brain potentials is translated into a digital command for a spelling device. The secondary objective of this study is to compare the efficacy of this spelling device with a more traditional assisitve technology called scanner interface. A scanner interface uses single clicks that can be obtaines with an adequate interface which exploits the remaining muscular activity from a patients.
Every patient will use each interface (P300 sepller and Scanning) with a randomized order. Results will bec o,pared in terms of information flow from the patient to the computer expressed in bit rate per minute.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Computer Interface | – | Device: Brain computer interfacePatients will test the brain computer interface system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- neuromuscular disease patients
Key inclusion criteria (1 listed)
- Adult older than 18y.o., diagnosed with neuromuscular disease, stable vital signs and informed consent
Key exclusion criteria (2 listed)
- History of seizure, brain damage, sight or auditory dysfunction, Atopic dermatitis, skin hypersensitivity to gold, patient under guardianship, illiterates or not able to cooperate , cognitive dysfunction
- Steinert disease, Merosine negative disease, Alpha-dystroglycanopathies
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 |
|---|---|---|
| Brain computer interfaceRecording the P300 Testing the device Using the device with a speller | Device | Brain Computer Interface |
Primary outcome
Bit rate (BR) the amount fo information that flows from the patient to the computer during the spelling session. This criterion is a combination of the number of symbols selected, the accuracy, and the time.
Time frame: 30 minutes
The comparison criteria for performance was the bitrate, br, that is defined by (Wolpow et al. 2000): 〖br=log〗_2 (M)+p.log_2 p+(1-p) 〖log〗_2 (1-p)/(M-1) where M=36 is the number of symbols p the spelling accuracy (the percentage of correctly identified symbols).
1 secondary outcome
patient satisfaction (visual analogic scale)
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
David Orlikowski, MDPhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication and Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bit rate (BR) the amount fo information that flows from the patient to the computer during the spelling session. This criterion is a combination of the number of symbols selected, the accuracy, and the time. (time frame: 30 minutes). 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 20 Apr 2017.