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Influence of Emotions on Decision-making in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive examination
viewing of video
Iowa Gambling Task
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring influence of emotions, positif emotional induction, decision making, Iowa Gambling Task

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for patients :

  • Diagnosis of the disease carried out by a hospital doctor
  • Stable treatment for two months minimum.
  • Mini-Mental Parkinson > 26
  • Under dopaminergic treatment

Exclusion Criteria for patients :

  • other neurological or psychiatric antecedents
  • anxio-depressive symptomatology
  • delusional or psychotic state

Inclusion Criteria for witnesses :

  • matched in age and sex
  • Vision and hearing normal or successfully corrected
  • Understand the French language
  • general level in the test standard

Exclusion Criteria for witnesses :

  • neurological or psychiatric diseases
  • anxio-depressive symptomatology

Sites / Locations

  • CHU de Grenoble Alpes
  • CHU de Saint Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

patients with Parkinson's disease

witnesses

Arm Description

cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test viewing of video : scale of differential emotions and Positive and Negative Affect Scale Test of Iowa Gambling Task

cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test viewing of video : scale of differential emotions and Positive and Negative Affect Scale Test of Iowa Gambling Task

Outcomes

Primary Outcome Measures

net score of Iowa Gambling Task Test
calculated by adding the number of cards taken in the right pile and subtracting it from the number of cards chosen in the wrong pile

Secondary Outcome Measures

Full Information

First Posted
November 10, 2017
Last Updated
January 15, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03342339
Brief Title
Influence of Emotions on Decision-making in Parkinson's Disease
Official Title
Influence of Emotions on Decision-making in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Parkinson's disease mainly affects the dopaminergic neurons of the Substancia nigra, which project on the striatum. Neuronal death within this structure leads to a decrease in dopamine levels. Dopamine is a neurotransmitter essential to the proper functioning of the basal ganglia highly involved in the control of voluntary and involuntary movements. It also leads to cognitive and behavioral changes. Among these changes, the investigators will mainly remember the idea of the emergence of difficulties to make the right decisions, for example at the financial, medical .... This disruption would be the result of executive dysfunction. By definition, executive functions allow us to evaluate, plan and organize our actions to achieve a goal.
Detailed Description
Some research shows that positive emotional states are associated with greater self-confidence, greater optimism, and better regulation of our decision-making. The goal is to test whether positive emotional induction could improve decision-making in Parkinson's disease. Listening to music would decrease anxiety levels and increase self-esteem levels. Who says Parkinson says dopamine deficiency and so the investigators can think that the investigators can help patients by inducing a positive emotion through musical stimulation. All participants will be subject to emotional induction. They will be divided into two different conditions: either they will be induced in a positive state, or they will be maintained in a neutral state. For this, video clips (positive or neutral) containing music will be presented. Immediately after the presentation of the video, participants will have to perform the Iowa Gambling Task test. This is a sequential task to evaluate decision-making capabilities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
influence of emotions, positif emotional induction, decision making, Iowa Gambling Task

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with Parkinson's disease
Arm Type
Other
Arm Description
cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test viewing of video : scale of differential emotions and Positive and Negative Affect Scale Test of Iowa Gambling Task
Arm Title
witnesses
Arm Type
Other
Arm Description
cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test viewing of video : scale of differential emotions and Positive and Negative Affect Scale Test of Iowa Gambling Task
Intervention Type
Other
Intervention Name(s)
cognitive examination
Intervention Description
mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
Intervention Type
Other
Intervention Name(s)
viewing of video
Intervention Description
viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale
Intervention Type
Other
Intervention Name(s)
Iowa Gambling Task
Intervention Description
Test of Iowa Gambling Task
Primary Outcome Measure Information:
Title
net score of Iowa Gambling Task Test
Description
calculated by adding the number of cards taken in the right pile and subtracting it from the number of cards chosen in the wrong pile
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for patients : Diagnosis of the disease carried out by a hospital doctor Stable treatment for two months minimum. Mini-Mental Parkinson > 26 Under dopaminergic treatment Exclusion Criteria for patients : other neurological or psychiatric antecedents anxio-depressive symptomatology delusional or psychotic state Inclusion Criteria for witnesses : matched in age and sex Vision and hearing normal or successfully corrected Understand the French language general level in the test standard Exclusion Criteria for witnesses : neurological or psychiatric diseases anxio-depressive symptomatology
Facility Information:
Facility Name
CHU de Grenoble Alpes
City
Grenoble
Country
France
Facility Name
CHU de Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of Emotions on Decision-making in Parkinson's Disease

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