Attitude to ComputersEarly Phase 13ElectrodsNCT01518426
Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population
A Early Phase 1 study testing EEG Recording (Emotiv) in people with Attitude to Computers, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Attitude to Computers
- What is being tested?
- EEG Recording (Emotiv)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Jul 2012
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers male or female aging over 18
- Signed informed consent
- Passed the preliminary exam
- Registered in the national database for persons willing to participate in Biomedical research
Who cannot join
- Visual or hearing problems
- Cognitive problems
- Illiterate persons
- Persons under Guardianship or Trusteeship
- Having Epilepsy
- Pregnant women Not covered by the social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.
The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).
Read the detailed description
Brain Computer Interface (BCI) are used to restore control and communication in patient with severe disabilities such as Locked In Syndrome (LIS) patients.
The aim of this study is to identify the most relevant recording technique for extraction of P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by principal investigator.
- Conditions
- Attitude to Computers
- Being tested
- EEG Recording (Emotiv)
- Keywords
- Brain computer interface, EEG recording, Electrodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG Recording (Emotiv)Device
Also called EEG recording
Record EEG during auditory oddball paradigms:
- with Emotiv EEG headset EMOTIV CAP (see http://www.emotiv.com)
- with 3 electrodes : 3 different types of electrodes at the time (needle, cupule 5mm, cupule 10mm)
| Study group | Role | What they receive |
|---|---|---|
| Extraction of P300 ERPs | Experimental | Extract P300 ERPs with Emotiv EEG headset Receives: Device: EEG Recording (Emotiv) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wilcoxon statistic (Area Under the Curve)
An Linear Discriminant Analysis (LDA) will be used to discriminate target and Algorithm performance (Wilcoxon statistic) for discrimination between occurrent and non-occurrent stimuli.
Signals will adequately be pre-processed: denoised and spatialy filtered (xDAWN). The Area Under the Receiver Operator Characteristic Curve (AUC) also called wilcoxon statistic will be used to identify the signals of best quality.
Measured: T0+2h (end of each technique)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attitude to ComputersStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Louis Mayaud, ENGINEER, Study director, Centre d'Investigation Clinique et Technologique 805
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518426
- Sponsor's protocol ID
- 2011-A00102-39
- Acronym
- 3Electrods
- Status last verified
- May 2014
- First submitted
- 22 Dec 2011
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.
- ClinicalTrials.gov ID
- NCT01518426
- Acronym / sponsor ID
- 3Electrods / 2011-A00102-39
- Conditions
- Attitude to Computers
- Keywords
- Brain computer interface, EEG recording, Electrodes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Jan 2012 (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 purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).
Detailed description
Brain Computer Interface (BCI) are used to restore control and communication in patient with severe disabilities such as Locked In Syndrome (LIS) patients.
The aim of this study is to identify the most relevant recording technique for extraction of P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by principal investigator.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extraction of P300 ERPs | Experimental | Device: EEG Recording (Emotiv)Extract P300 ERPs with Emotiv EEG headset |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers male or female aging over 18
- Signed informed consent
- Passed the preliminary exam
- Registered in the national database for persons willing to participate in Biomedical research
Key exclusion criteria (6 listed)
- Visual or hearing problems
- Cognitive problems
- Illiterate persons
- Persons under Guardianship or Trusteeship
- Having Epilepsy
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 |
|---|---|---|
| EEG Recording (Emotiv)Also: EEG recordingRecord EEG during auditory oddball paradigms: * with Emotiv EEG headset EMOTIV CAP (see http://www.emotiv.com) * with 3 electrodes : 3 different types of electrodes at the time (needle, cupule 5mm, cupule 10mm) | Device | Extraction of P300 ERPs |
Primary outcome
Wilcoxon statistic (Area Under the Curve)
Time frame: T0+2h (end of each technique)
An Linear Discriminant Analysis (LDA) will be used to discriminate target and Algorithm performance (Wilcoxon statistic) for discrimination between occurrent and non-occurrent stimuli. Signals will adequately be pre-processed: denoised and spatialy filtered (xDAWN). The Area Under the Receiver Operator Characteristic Curve (AUC) also called wilcoxon statistic will be used to identify the signals of best quality.
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 6 May 2014.
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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.
Louis Mayaud, ENGINEER study director
Centre d'Investigation Clinique et Technologique 805
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EEG Recording (Emotiv) in people with Attitude to Computers, 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 4 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: finished, as of the sponsor's last update on 6 May 2014. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wilcoxon statistic (Area Under the Curve) (time frame: T0+2h (end of each technique)). 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 6 May 2014.