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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04974437
Other study ID # 2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date November 25, 2021

Study information

Verified date November 2021
Source Instituto del Corazon, Argentina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date November 25, 2021
Est. primary completion date October 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Incor La Rioja

Sponsors (1)

Lead Sponsor Collaborator
Instituto del Corazon, Argentina

Country where clinical trial is conducted

Argentina, 

References & Publications (9)

Gu S, Wang F, Cao C, Wu E, Tang YY, Huang JH. An Integrative Way for Studying Neural Basis of Basic Emotions With fMRI. Front Neurosci. 2019 Jun 19;13:628. doi: 10.3389/fnins.2019.00628. eCollection 2019. — View Citation

Gur RE, Gur RC. Functional magnetic resonance imaging in schizophrenia. Dialogues Clin Neurosci. 2010;12(3):333-43. Review. — View Citation

Kassam KS, Markey AR, Cherkassky VL, Loewenstein G, Just MA. Identifying Emotions on the Basis of Neural Activation. PLoS One. 2013 Jun 19;8(6):e66032. doi: 10.1371/journal.pone.0066032. Print 2013. — View Citation

Kragel PA, Knodt AR, Hariri AR, LaBar KS. Decoding Spontaneous Emotional States in the Human Brain. PLoS Biol. 2016 Sep 14;14(9):e2000106. doi: 10.1371/journal.pbio.2000106. eCollection 2016 Sep. — View Citation

Kragel PA, LaBar KS. Multivariate neural biomarkers of emotional states are categorically distinct. Soc Cogn Affect Neurosci. 2015 Nov;10(11):1437-48. doi: 10.1093/scan/nsv032. Epub 2015 Mar 25. — View Citation

Michelini, Y. Características de la experiencia emocional inducida mediante fragmentos de películas en una muestra de jóvenes argentinos. Interdisciplinaria, 2015, 32, 2, 367-382.

Muñoz Rodriguez M, Korzeniowski C. Validación del cuestionario epidemiológico en sintomatología mental -CESIM- en población Argentina. Revista de Salud Pública, (XXIII) 2:8-24 Junio 2019

Posner J, Russell JA, Gerber A, Gorman D, Colibazzi T, Yu S, Wang Z, Kangarlu A, Zhu H, Peterson BS. The neurophysiological bases of emotion: An fMRI study of the affective circumplex using emotion-denoting words. Hum Brain Mapp. 2009 Mar;30(3):883-95. doi: 10.1002/hbm.20553. — View Citation

Ríos-Lago M. [Functional magnetic resonance and neuropsychology: basic concepts]. Radiologia. 2008 Sep-Oct;50(5):351-65; quizz 365. Spanish. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in fMRI brain activation response in specific brain regions in response to positive and negative emotional stimuli 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.
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