Metabolic Activation of Brain Areas With Emotional Stimuli Compared With Score in Psychological Test (fMRI)

November 25, 2021 updated by: Ruben Novoa, MD, Instituto del Corazon, Argentina

Quantitative Assessment of the Activation of Brain Areas With Positive and Negative Emotional Stimuli and Its Correlation With Degrees of Emotional Disorder.

Quantitative assessment of the activation of brain areas by functional magnetic resonance imaging (fRMI) in the face of positive and negative emotional stimuli using audiovisual materials validated for the local population and its correlation with degrees of emotional disorder based on a score obtained by a validated questionnaire for the local population, in 16 volunteers from the city of La Rioja in Argentina.

Study Overview

Status

Completed

Conditions

Detailed Description

The technology applied in fMRI allows us to visualize on a color scale the changes in blood flow in those sectors of the brain that increase their metabolic activity during a given action. This is achieved by mapping the cerebral blood volume, which increases or decreases according to the metabolic activity in a certain region of the brain. This indirect method of measuring the metabolic activity of brain areas is very useful for anatomically identifying motor areas and critical functions in individual patients prior to neurosurgery, to allow better surgical planning. Currently this is its main application in healthcare practice. In the field of research it is applied in clinical neurology, psychiatry and psychology. Studies have been conducted on the activations of brain regions in basic emotions. There is less data on the quantitative differences of these activations in the Argentine population according to the degree of emotional disorder, this being the object of study of this project. Emotional disorders are transversal to different pathologies, with or without a psychotic component.

Study Type

Observational

Enrollment (Actual)

16

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

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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Volunteer participants from the population of the city of La Rioja in Argentina, over 21 years of age.

Description

Inclusion Criteria:

- Must be able to understand the instructions and collaborate during the data adquisition.

Exclusion Criteria:

  • Any contraindication to enter an MRI (for example, a pacemaker)
  • Claustrophobia.

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
Differences in fMRI brain activation response in specific brain regions in response to positive and negative emotional stimuli
Time Frame: Cross sectional adquistion of data with fMRI in a 20 minutes session after answering a questionnaire.

A score will be assigned to each participant according to the results obtained in a validated questionnaire to categorize emotional disorder with 37 questions, each of them with a score of 0, 1 or 2 according to the answer, to give a score to each participant that will be on the scale from 0 to 74.

The stimuli consist of the projection of audiovisual material validated to generate positive or negative emotions. The activations are quantified in a 1.5 Tesla resonator and the units of measurement for each region of interest will be cm3 of activated tissue and Z-value of fMRI activation.

Once the informed consent is signed, the participant is asked to answer the questionnaire to categorize the emotional score. After this survey, the fMRI is acquired, measuring the activation by areas from the beginning of the audiovisual stimuli until their completion. The time for the fMRI acquisition session for each participant in this cross-sectional study is estimated 20-minute .
Cross sectional adquistion of data with fMRI in a 20 minutes session after answering a questionnaire.

Collaborators and Investigators

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

Sponsor

Instituto del Corazon, Argentina

Investigators

  • Principal Investigator: Ruben F Novoa, MD, InCor Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2021

Primary Completion (ACTUAL)

October 25, 2021

Study Completion (ACTUAL)

November 25, 2021

Study Registration Dates

First Submitted

June 23, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (ACTUAL)

July 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) will be shared with researchers who provide a methodologically sound proposal.

IPD Sharing Time Frame

Immediately following publication and ending 36 months following article publication.

IPD Sharing Access Criteria

Proposals should be directed to rubennnovoa@gmail.com. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

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