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Induction and Recognition of Emotions (IRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353947
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
Asociación Parkinson Valencia
Information provided by (Responsible Party):
University of Valencia

Brief Summary:
This study evaluates the differences in cognitive function between healthy older adults, older adults with mild Alzheimer's type dementia and older adults with Parkinson's disease and if there are differences in valence assessment and activation that produce them a mood induction task. Subjects are assessed using neuropsychological tests and then a mood induction task based on movie clips is applied.

Condition or disease Intervention/treatment
Healthy Older Adults Alzheimer's Disease Parkinson's Disease Diagnostic Test: Mini Cognitive Examination (MCE) Diagnostic Test: Beck Depression Inventory-II (BDI-II) Diagnostic Test: Global Deterioration Scale (GDS) Diagnostic Test: Memory alteration test (M@T) Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC) Diagnostic Test: Barcelona test (BT) Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT) Diagnostic Test: Frontal assessment battery (FAB) Diagnostic Test: Positive and Negative Affect Scale (PANAS) Diagnostic Test: Auto-Assessment Manikins (SAM)

Detailed Description:

Different neuropsychological tests will be used to assess the differences in cognitive function in the different groups, whose scores are expected to be lower in the group of older adults with Alzheimer's disease (AD) and older adults with Parkinson's disease (PD).

After studying the cognitive function in the different groups, we proceed to check through a task based on movie clips if there are also differences in the valence assessment (liking/disliking depending on the emotion induced by scenes from different films) and activation (excitement caused by each one of the movie scenes), hoping to find differences for the negative emotions taking into account the cognitive difficulties that both (the EA group and the EP group) may have for processing this type of cognitively more demanding information; instead, it is possible that the positivity effect continues to affect these patients so that for positive emotions there are no differences between the different groups.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Induction and Recognition of Emotions in Healthy Older Adults, Alzheimer's Disease and Parkinson's Disease
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : November 30, 2020


Group/Cohort Intervention/treatment
Healthy older adults
Healthy older adults with 65 years or older
Diagnostic Test: Mini Cognitive Examination (MCE)
This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.

Diagnostic Test: Beck Depression Inventory-II (BDI-II)
This test evaluates the absence or presence of depressive symptoms.

Diagnostic Test: Global Deterioration Scale (GDS)
This scale measures the level of deterioration of the subject.

Diagnostic Test: Memory alteration test (M@T)
In this test different memory subtypes are evaluated.

Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC)
This test is used to assess immediate memory, deferred memory and learning ability.

Diagnostic Test: Barcelona test (BT)
This test evaluates categorical evocation and verbal fluency. The categorical recall subtest consists of recalling the maximum number of words linked to a specific category "animals" in 1 minute. In the case of verbal fluency, the subject is asked to evoke the maximum number of words that begin with the letter "p" in 3 minutes.

Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT)
In this test, the person must carefully copy a complex geometric drawing, which must be memorized later. The first part evaluates multiple cognitive processes such as planning, motor skills, working memory, and visual-constructive and spatial skills. In the second part, memory is evaluated.

Diagnostic Test: Positive and Negative Affect Scale (PANAS)
It is a self-report questionnaire made up of 20 items (10 of positive affect and another 10 of negative affect) that the subject must answer, obtaining in this way a score in positive affectivity (AP subscale) and another in negative affectivity (AN subscale).

Diagnostic Test: Auto-Assessment Manikins (SAM)
It is a self-report questionnaire that assesses the emotional response of the subject, in this case, through a mood induction task that plays different films scenes.

Older adults with Alzheimer's disease
Older adults with Alzheimer's disease with 65 years or older
Diagnostic Test: Mini Cognitive Examination (MCE)
This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.

Diagnostic Test: Beck Depression Inventory-II (BDI-II)
This test evaluates the absence or presence of depressive symptoms.

Diagnostic Test: Global Deterioration Scale (GDS)
This scale measures the level of deterioration of the subject.

Diagnostic Test: Memory alteration test (M@T)
In this test different memory subtypes are evaluated.

Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC)
This test is used to assess immediate memory, deferred memory and learning ability.

Diagnostic Test: Barcelona test (BT)
This test evaluates categorical evocation and verbal fluency. The categorical recall subtest consists of recalling the maximum number of words linked to a specific category "animals" in 1 minute. In the case of verbal fluency, the subject is asked to evoke the maximum number of words that begin with the letter "p" in 3 minutes.

Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT)
In this test, the person must carefully copy a complex geometric drawing, which must be memorized later. The first part evaluates multiple cognitive processes such as planning, motor skills, working memory, and visual-constructive and spatial skills. In the second part, memory is evaluated.

Diagnostic Test: Positive and Negative Affect Scale (PANAS)
It is a self-report questionnaire made up of 20 items (10 of positive affect and another 10 of negative affect) that the subject must answer, obtaining in this way a score in positive affectivity (AP subscale) and another in negative affectivity (AN subscale).

Diagnostic Test: Auto-Assessment Manikins (SAM)
It is a self-report questionnaire that assesses the emotional response of the subject, in this case, through a mood induction task that plays different films scenes.

Older adults with Parkinson's disease
Older adults with Alzheimer's disease with 65 years or older
Diagnostic Test: Mini Cognitive Examination (MCE)
This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.

Diagnostic Test: Beck Depression Inventory-II (BDI-II)
This test evaluates the absence or presence of depressive symptoms.

Diagnostic Test: Global Deterioration Scale (GDS)
This scale measures the level of deterioration of the subject.

Diagnostic Test: Memory alteration test (M@T)
In this test different memory subtypes are evaluated.

Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC)
This test is used to assess immediate memory, deferred memory and learning ability.

Diagnostic Test: Barcelona test (BT)
This test evaluates categorical evocation and verbal fluency. The categorical recall subtest consists of recalling the maximum number of words linked to a specific category "animals" in 1 minute. In the case of verbal fluency, the subject is asked to evoke the maximum number of words that begin with the letter "p" in 3 minutes.

Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT)
In this test, the person must carefully copy a complex geometric drawing, which must be memorized later. The first part evaluates multiple cognitive processes such as planning, motor skills, working memory, and visual-constructive and spatial skills. In the second part, memory is evaluated.

Diagnostic Test: Frontal assessment battery (FAB)
This test is a composite tool for assessing executive functions related to the frontal lobe.

Diagnostic Test: Positive and Negative Affect Scale (PANAS)
It is a self-report questionnaire made up of 20 items (10 of positive affect and another 10 of negative affect) that the subject must answer, obtaining in this way a score in positive affectivity (AP subscale) and another in negative affectivity (AN subscale).

Diagnostic Test: Auto-Assessment Manikins (SAM)
It is a self-report questionnaire that assesses the emotional response of the subject, in this case, through a mood induction task that plays different films scenes.




Primary Outcome Measures :
  1. Mini-Mental State Examination (MMSE) [ Time Frame: 5-10 minutes ]
    This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.

  2. Beck Depression Inventory-II (BDI-II) [ Time Frame: 5-10 minutes ]
    In this test, a score of 0-13 indicates absence of depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression.

  3. Global Deterioration Scale (GDS) [ Time Frame: 30 minutes ]
    This scale indicates seven possible stages: 1. Absence of Cognitive Deficit; 2. Very slight cognitive deficit; 3. Mild Cognitive Deficit; 4. Moderate cognitive deficit; 5. Moderately severe cognitive deficit; 6. Severe cognitive deficit; 7. Very severe cognitive deficit.

  4. Memory alteration test (M@T) [ Time Frame: 5-10 minutes ]
    This cognitive test is evaluated on a maximum of 50 points. The optimal cut-off point for distinguishing mild cognitive impairment of the amnesiac type from subjective memory complaints is 37 points. The optimal cut-off point for Alzheimer's disease is 31 points.

  5. Spanish-Complutense Verbal Learning Test (TAVEC) [ Time Frame: 30 minutes ]
    The evaluator reads a 16-word shopping list in five different essays and in each of them the evaluated person must mention those words that he or she remembers. After 20 minutes, the subject is asked to remember them again.

  6. Barcelona test (BT) [ Time Frame: 5 minutes ]
    In this test, the subject is considered to have a good categorical evocation when he is able to evoke more than 16 animals in 1 minute and a good verbal fluency when he is able to evoke more than 19 words beginning with "p" in 3 minutes.

  7. Rey-Osterrieth Complex Figure Test (ROCFT) [ Time Frame: 10 minutes ]
    The direct score (PD) in the copy of the Rey figure that would leave 50% of the population below is 30 points, while in the reproduction of the Rey figure from memory the PD that would leave 50% below of the population is 21 points.

  8. Frontal assessment battery (FAB) [ Time Frame: 10 minutes ]
    The maximum score to be obtained in this test is 18 points. To consider that the subject presents alterations in the frontal lobe and, therefore, altered executive functions, his score must be equal to or less than 11 points.

  9. Positive and Negative Affect Scale (PANAS) [ Time Frame: 10 minutes ]
    The final score of this scale is the sum of the 10 terms on the positive scale and the sum of the 10 terms on the negative scale, with the value assigned for the responses on the positive scale being positive and negative for the responses on the negative scale.

  10. Auto-Assessment Manikins (SAM) [ Time Frame: 5-10 minutes ]
    This questionnaire measures the valence (liking/disliking depending on the emotion induced by scenes from different movies), the arousal (excitement caused by each of the movie scenes) and mastery or emotional control (self-perception of the control exerted on the environment and the emotion itself).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 99 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Healthy older adults will be recruited from the Third Age Classrooms of the municipality of Quart de Poblet.
  • The older adults with mild Alzheimer's disease will be recruited through the Neurology Department of the General Hospital of Valencia.
  • The older adults with Parkinson's disease will be recruited through the Valencia Parkinson Association.
Criteria

Inclusion Criteria:

For the group of healthy older adults:

  • MEC score greater than 26 points.
  • GDS between 1 and 3.

For the mild EA group:

  • MEC score between 18 and 23 points.
  • GDS between 3 and 4.

For the EP group:

  • MEC score greater than 23 points.
  • GDS between 1 and 3.
  • FAB score equal to or less than 11 points.

General Exclusion Criteria:

Participants cannot have:

  • Significant asymptomatic neurovascular disease
  • History of previous symptomatic stroke
  • Alcohol or drug abuse/dependence
  • Severe psychiatric symptoms
  • Depressive symptoms higher than mild

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353947


Contacts
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Contact: Juan C Melendez, Psychology 96 398 38 44 juan.c.melendez@uv.es
Contact: Encarnación Satorres, Psychology 96 162 56 15 encarna.satorres@uv.es

Locations
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Spain
University of Valencia Recruiting
Valencia, Spain, 46010
Contact: Juan C Melendez, Psychology    96 398 38 44    juan.c.melendez@uv.es   
Contact: Encarnación Satorres, Psychology    96 162 56 15    encarna.satorres@uv.es   
Principal Investigator: Juan C Melendez, Psychology         
Sub-Investigator: Yaiza Lora, Psychology         
Sub-Investigator: Encarnación Satorres, Psychology         
Sponsors and Collaborators
University of Valencia
Asociación Parkinson Valencia
Investigators
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Principal Investigator: Juan C Melendez, Psychology University of Valencia
Publications of Results:
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Responsible Party: University of Valencia
ClinicalTrials.gov Identifier: NCT04353947    
Other Study ID Numbers: UV-INV_ETICA-1217558
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

All the information of the study, as well as its results, will be shared in scientific publications and conferences related to the research area.

The information that is intended to be published in scientific journals includes: 1) Study Protocol, 2) Statistical Analysis, 3) Informed Consent Form, 4) Clinical Study Results.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Valencia:
Healthy older adults
Alzheimer's disease
Parkinson's disease
Mood induction
Positive emotions
Negative emotions
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders