Emotional DisorderfMRINCT04974437
Metabolic Activation of Brain Areas With Emotional Stimuli Compared With Score in Psychological Test
An observational study of Emotional Disorder, run by Instituto del Corazon, Argentina at 1 site in Argentina.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Disorder
- How many people
- 16 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Aug 2021to 25 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer participants from the population of the city of La Rioja in Argentina, over 21 years of age.
Who may be able to join
- Must be able to understand the instructions and collaborate during the data adquisition.
Who cannot join
- Any contraindication to enter an MRI (for example, a pacemaker)
- Claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Emotional Disorder
- Keywords
- fMRI, Emotion, Cerebral blood volume
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Cross sectional adquistion of data with fMRI in a 20 minutes session after answering a questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Aug 2021
- Primary completion25 Oct 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto del Corazon, Argentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Novoa, MD, Instituto del Corazon, Argentina
- Investigators
- Ruben F Novoa, MD, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974437
- Sponsor's protocol ID
- 2
- Acronym
- fMRI
- Status last verified
- Nov 2021
- First submitted
- 23 Jun 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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
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.
PubMed 31275107Kragel 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.
PubMed 27627738Kragel 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.
PubMed 25813790Kassam 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.
PubMed 23840392Gur 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.
PubMed 20954429Posner 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.
PubMed 18344175Rios-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.
PubMed 19055911
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of the Activation of Brain Areas With Positive and Negative Emotional Stimuli and Its Correlation With Degrees of Emotional Disorder.
- ClinicalTrials.gov ID
- NCT04974437
- Acronym / sponsor ID
- fMRI / 2
- Conditions
- Emotional Disorder
- Keywords
- fMRI, Emotion, Cerebral blood volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Instituto del Corazon, ArgentinaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer participants from the population of the city of La Rioja in Argentina, over 21 years of age.
Key inclusion criteria (1 listed)
- Must be able to understand the instructions and collaborate during the data adquisition.
Key exclusion criteria (2 listed)
- Any contraindication to enter an MRI (for example, a pacemaker)
- Claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- BackgroundMichelini, Y. Características de la experiencia emocional inducida mediante fragmentos de películas en una muestra de jóvenes argentinos. Interdisciplinaria, 2015, 32, 2, 367-382.
- BackgroundMuñoz 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: PubMed 31275107Gu 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.
- Background: PubMed 27627738Kragel 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.
- Background: PubMed 25813790Kragel 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.
- Background: PubMed 23840392Kassam 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.
- Background: PubMed 20954429Gur 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.
- Background: PubMed 18344175Posner 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.
- Background: PubMed 19055911Rios-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben F Novoa, MD principal investigator
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotional Disorder, run by Instituto del Corazon, Argentina at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04974437, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.