Changes in Brain Tissue Pulsatility With Musical Stimuli (M-PULSE)

August 20, 2019 updated by: University Hospital, Tours
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tours, France, 37044
        • DESMIDT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amplitude of variations in brain tissue pulsatility
Time Frame: Baseline
in micrometers
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: Baseline
beat by minute
Baseline
breathing rate
Time Frame: Baseline
Frequency
Baseline
skin conductance
Time Frame: Baseline
in milliVolt
Baseline
score of barcelona music reward questionnary (BMQR)
Time Frame: 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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

April 26, 2019

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • RIPH3-RNI19-M-PULSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

3
Subscribe