Musical EmotionsQUAdEMCENCT03753230
Clinical Qualification Study of Electroencephalographic Mobile Equipment for the Capture of Emotions
A study testing Electroencephalography in people with Musical Emotions, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The study aim to determine the reliability of various EEG wireless headsets. Their signal will be compared to standard high-density EEG recording during music listening. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Musical Emotions
- What is being tested?
- Electroencephalography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right handed healthy people
- sensitive to "music chill" (Barcelona Reward music Questionnaire>50)
- having given their participation agreement
- individual with health insurance coverage.
Who cannot join
- Pregnant women
- individuals in "exclusion period" of another study
- subjects with auditory deficits
Trial locations and contacts
No sites are listed yet.
About this study
The study aim to determine the reliability of various EEG wireless headsets. Their signal will be compared to standard high-density EEG recording during music listening.
- Conditions
- Musical Emotions
- Being tested
- Electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDevice
Cerebral measurements from electroencephalography devices while music is presented to the participant
| Study group | Role | What they receive |
|---|---|---|
| EEG Device 1 | Experimental | Participants are listening to music while their neural activity is recorded with Emotiv Epoc+ Receives: Device: Electroencephalography |
| EEG Device 2 | Experimental | Participants are listening to music while their neural activity is recorded with g.tec Receives: Device: Electroencephalography |
| High density EEG | Active comparator | Participants are listening to music while their neural activity is recorded with high density 256 electrodes EEG Geodesic Receives: Device: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality and spatial/temporal coherence in oscillatory responses patterns recorded with EEG wireless headsets (Emotiv and g.tec) and with the EEG high density gold standard
Brain activity will be recorded continuously during musical extract listening. The coherence of EEG activity between the three different devices on similar electrodes will be measured and compared for several brainwaves (delta, theta, alpha, beta, gamma)
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musical EmotionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753230
- Sponsor's protocol ID
- API/2018/92
- Acronym
- QUAdEMCE
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Qualification Study of Electroencephalographic Mobile Equipment for the Capture of Emotions
- ClinicalTrials.gov ID
- NCT03753230
- Acronym / sponsor ID
- QUAdEMCE / API/2018/92
- Conditions
- Musical Emotions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Nov 2018 (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.
The study aim to determine the reliability of various EEG wireless headsets. Their signal will be compared to standard high-density EEG recording during music listening.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EEG Device 1 | Experimental | Device: ElectroencephalographyParticipants are listening to music while their neural activity is recorded with Emotiv Epoc+ |
| EEG Device 2 | Experimental | Device: ElectroencephalographyParticipants are listening to music while their neural activity is recorded with g.tec |
| High density EEG | Active comparator | Device: ElectroencephalographyParticipants are listening to music while their neural activity is recorded with high density 256 electrodes EEG Geodesic |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Right handed healthy people
- sensitive to "music chill" (Barcelona Reward music Questionnaire>50)
- having given their participation agreement
- individual with health insurance coverage.
Key exclusion criteria (3 listed)
- Pregnant women
- individuals in "exclusion period" of another study
- subjects with auditory deficits
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 |
|---|---|---|
| ElectroencephalographyCerebral measurements from electroencephalography devices while music is presented to the participant | Device | EEG Device 1, EEG Device 2, High density EEG |
Primary outcome
Quality and spatial/temporal coherence in oscillatory responses patterns recorded with EEG wireless headsets (Emotiv and g.tec) and with the EEG high density gold standard
Time frame: Up to 2 weeks
Brain activity will be recorded continuously during musical extract listening. The coherence of EEG activity between the three different devices on similar electrodes will be measured and compared for several brainwaves (delta, theta, alpha, beta, gamma)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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Recruiting
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Alzheimer Disease, Early Onset, Parkinsons Disease with Dementia
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.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography in people with Musical Emotions, run by Centre Hospitalier Universitaire de Besancon.
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 3 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 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Lionel PAZART, MD, PhD, MPH (+33 381 218 622, lpazart@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality and spatial/temporal coherence in oscillatory responses patterns recorded with EEG wireless headsets (Emotiv and g.tec) and with the EEG high density gold standard (time frame: Up to 2 weeks). 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 2018.