NCT04974437

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

June 23, 2021

Last Update Submit

November 25, 2021

Conditions

Keywords

fMRIEmotionCerebral blood volume

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incor

La Rioja, 5300, Argentina

Location

Related Publications (9)

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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 31275107BACKGROUND
  • 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.

    PMID: 27627738BACKGROUND
  • 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.

    PMID: 25813790BACKGROUND
  • 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.

    PMID: 23840392BACKGROUND
  • Gur RE, Gur RC. Functional magnetic resonance imaging in schizophrenia. Dialogues Clin Neurosci. 2010;12(3):333-43. doi: 10.31887/DCNS.2010.12.3/rgur.

    PMID: 20954429BACKGROUND
  • 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.

    PMID: 18344175BACKGROUND
  • Rios-Lago M. [Functional magnetic resonance and neuropsychology: basic concepts]. Radiologia. 2008 Sep-Oct;50(5):351-65; quizz 365. doi: 10.1016/s0033-8338(08)76050-8. Spanish.

    PMID: 19055911BACKGROUND

Study Officials

  • Ruben F Novoa, MD

    InCor Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Magnetic Resonance Imaging, Principal Investigator

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 23, 2021

Study Start

August 1, 2021

Primary Completion

October 25, 2021

Study Completion

November 25, 2021

Last Updated

November 29, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following publication and ending 36 months following article publication.
Access Criteria
Proposals should be directed to rubennnovoa@gmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations