Emotional Disorder Clinical Trial
— fMRIOfficial title:
Quantitative Assessment of the Activation of Brain Areas With Positive and Negative Emotional Stimuli and Its Correlation With Degrees of Emotional Disorder.
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 |
Verified date | November 2021 |
Source | Instituto del Corazon, Argentina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Incor | La Rioja |
Lead Sponsor | Collaborator |
---|---|
Instituto del Corazon, Argentina |
Argentina,
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
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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