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M-PULSE: Changes in Brain Tissue Pulsatility With Musical Stimuli

Sponsor
University Hospital, Tours (Other)
Overall Status
Completed
CT.gov ID
NCT03867422
Collaborator
(none)
25
Enrollment
1
Location
24
Actual Duration (Days)
31.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Changes in Brain Tissue Pulsatility With Musical Stimuli
    Actual Study Start Date :
    Apr 2, 2019
    Actual Primary Completion Date :
    Apr 26, 2019
    Actual Study Completion Date :
    Apr 26, 2019

    Outcome Measures

    Primary Outcome Measures

    1. amplitude of variations in brain tissue pulsatility [Baseline]

      in micrometers

    Secondary Outcome Measures

    1. heart rate [Baseline]

      beat by minute

    2. breathing rate [Baseline]

      Frequency

    3. skin conductance [Baseline]

      in milliVolt

    4. score of barcelona music reward questionnary (BMQR) [Baseline]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • more or equal 18 years-old and less or equal 45 years-old

    • no known hearing problem

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DESMIDT Tours France 37044

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT03867422
    Other Study ID Numbers:
    • RIPH3-RNI19-M-PULSE
    First Posted:
    Mar 8, 2019
    Last Update Posted:
    Aug 21, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 21, 2019