Induction and Recognition of Emotions

Parkinson's Disease Clinical Trial

— IRE  

Official title:

Induction and Recognition of Emotions in Healthy Older Adults, Alzheimer's Disease and Parkinson's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04353947
• Other study ID #: UV-INV_ETICA-1217558
• Status: Withdrawn
• Start date: March 2, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: May 2021
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Healthy Older Adults
• Parkinson Disease
• Parkinson's Disease

Intervention

Diagnostic Test:
• Mini Cognitive Examination (MCE)
This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.
• Beck Depression Inventory-II (BDI-II)
This test evaluates the absence or presence of depressive symptoms.
• Global Deterioration Scale (GDS)
This scale measures the level of deterioration of the subject.
• Memory alteration test (M@T)
In this test different memory subtypes are evaluated.
• Spanish-Complutense Verbal Learning Test (TAVEC)
This test is used to assess immediate memory, deferred memory and learning ability.
• 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.
• 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.
• Frontal assessment battery (FAB)
This test is a composite tool for assessing executive functions related to the frontal lobe.
• 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).
• 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.

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Asociación Parkinson Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Alves H, Koch A, Unkelbach C. The differential similarity of positive and negative information - an affect-induced processing outcome? Cogn Emot. 2019 Sep;33(6):1224-1238. doi: 10.1080/02699931.2018.1549022. Epub 2018 Nov 26. — View Citation

Alves H, Koch A, Unkelbach C. Why Good Is More Alike Than Bad: Processing Implications. Trends Cogn Sci. 2017 Feb;21(2):69-79. doi: 10.1016/j.tics.2016.12.006. Epub 2017 Jan 4. Review. — View Citation

Carvalho S, Leite J, Galdo-Álvarez S, Gonçalves OF. The Emotional Movie Database (EMDB): a self-report and psychophysiological study. Appl Psychophysiol Biofeedback. 2012 Dec;37(4):279-94. doi: 10.1007/s10484-012-9201-6. — View Citation

Fernández-Aguilar L, Ricarte J, Ros L, Latorre JM. Emotional Differences in Young and Older Adults: Films as Mood Induction Procedure. Front Psychol. 2018 Jul 3;9:1110. doi: 10.3389/fpsyg.2018.01110. eCollection 2018. — View Citation

Nashiro K, Mather M. Effects of emotional arousal on memory binding in normal aging and Alzheimer's disease. Am J Psychol. 2011 Fall;124(3):301-12. — View Citation

Reed AE, Carstensen LL. The theory behind the age-related positivity effect. Front Psychol. 2012 Sep 27;3:339. doi: 10.3389/fpsyg.2012.00339. eCollection 2012. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination (MMSE)	This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.	5-10 minutes
Primary	Beck Depression Inventory-II (BDI-II)	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.	5-10 minutes
Primary	Global Deterioration Scale (GDS)	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.	30 minutes
Primary	Memory alteration test (M@T)	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.	5-10 minutes
Primary	Spanish-Complutense Verbal Learning Test (TAVEC)	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.	30 minutes
Primary	Barcelona test (BT)	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.	5 minutes
Primary	Rey-Osterrieth Complex Figure Test (ROCFT)	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.	10 minutes
Primary	Frontal assessment battery (FAB)	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.	10 minutes
Primary	Positive and Negative Affect Scale (PANAS)	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 minutes
Primary	Auto-Assessment Manikins (SAM)	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).	5-10 minutes