HealthyM-PULSENCT03867422
Changes in Brain Tissue Pulsatility With Musical Stimuli
An observational study of Healthy, run by University Hospital, Tours at 1 site in France.
Trial summary
Music Perception is well known to elicit emotions and neuronal activations. Changes in the cerebrovascular physiology have also been found in emotional tasks but only few studies have investigated markers of cerebrovascular physiology in a music task and no study has used the Ultrasound method of Tissue Pulsatility… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Healthy
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2019to 26 Apr 2019
- 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 to 45 years
- All sexes
- Adult
Study population: Healthy volunteers
Who may be able to join
- more or equal 18 years-old and less or equal 45 years-old
- no known hearing problem
Who cannot join
- professional musician
- history of neurologic, psychiatric or cadiologic disease
- treatment which could impact parameters of brain tissue pulsatility and peripheral nervous system
- opposition to use the data
Trial locations and contacts
1 site in 1 country.
About this study
Music Perception is well known to elicit emotions and neuronal activations. Changes in the cerebrovascular physiology have also been found in emotional tasks but only few studies have investigated markers of cerebrovascular physiology in a music task and no study has used the Ultrasound method of Tissue Pulsatility Imaging (TPI) in a music task. The use of TPI to measure reactivity of Brain Tissue Pulsatility Imaging (BTP) could further elucidate the cerebral basis of music perception.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
amplitude of variations in brain tissue pulsatility
in micrometers
Measured: Baseline
Secondary outcomes (4)
heart rate
beat by minute
Measured: Baseline
breathing rate
Frequency
Measured: Baseline
skin conductance
in milliVolt
Measured: Baseline
score of barcelona music reward questionnary (BMQR)
BMQR: Barcellona Music Reward Questionnaire for the evaluation of musical anhedonia;
- Only the total score of musical reward will be reported; for total score, minimum value is 20, maximum value is 100. Values under 40 represent low values in the overall score; values above 60 indicate high values in the overall score;
- High global score (>60) represents a better outcome; low global score (<40) represents a worse outcome, notably an impairment in music reward processing;
- The overall score is computed by adding raw scores of the items (except for items 2 and 5, which need to be reversed).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start2 Apr 2019
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867422
- Sponsor's protocol ID
- RIPH3-RNI19-M-PULSE
- Acronym
- M-PULSE
- Status last verified
- Aug 2019
- First submitted
- 4 Mar 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Brain Tissue Pulsatility With Musical Stimuli
- ClinicalTrials.gov ID
- NCT03867422
- Acronym / sponsor ID
- M-PULSE / RIPH3-RNI19-M-PULSE
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 8 Mar 2019 (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.
Music Perception is well known to elicit emotions and neuronal activations. Changes in the cerebrovascular physiology have also been found in emotional tasks but only few studies have investigated markers of cerebrovascular physiology in a music task and no study has used the Ultrasound method of Tissue Pulsatility Imaging (TPI) in a music task. The use of TPI to measure reactivity of Brain Tissue Pulsatility Imaging (BTP) could further elucidate the cerebral basis of music perception.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- more or equal 18 years-old and less or equal 45 years-old
- no known hearing problem
Key exclusion criteria (4 listed)
- professional musician
- history of neurologic, psychiatric or cadiologic disease
- treatment which could impact parameters of brain tissue pulsatility and peripheral nervous system
- opposition to use the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
amplitude of variations in brain tissue pulsatility
Time frame: Baseline
in micrometers
4 secondary outcomes
heart rate
Time frame: Baseline
breathing rate
Time frame: Baseline
skin conductance
Time frame: Baseline
score of barcelona music reward questionnary (BMQR)
Time frame: Baseline
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 21 Aug 2019.
- 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?
An observational study of Healthy, run by University Hospital, Tours 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 2 inclusion and 4 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 21 Aug 2019. 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?
amplitude of variations in brain tissue pulsatility (time frame: Baseline). 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 21 Aug 2019.