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

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ClinicalTrials.gov Identifier: NCT03342339
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: cognitive examination Other: viewing of video Other: Iowa Gambling Task Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influence of Emotions on Decision-making in Parkinson's Disease
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
patients with Parkinson's disease
  1. cognitive examination : mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
  2. viewing of video : scale of differential emotions and Positive and Negative Affect Scale
  3. Test of Iowa Gambling Task
Other: cognitive examination
mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test

Other: viewing of video
viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale

Other: Iowa Gambling Task
Test of Iowa Gambling Task

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

Other: viewing of video
viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale

Other: Iowa Gambling Task
Test of Iowa Gambling Task




Primary Outcome Measures :
  1. net score of Iowa Gambling Task Test [ Time Frame: day 1 ]
    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



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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03342339


Contacts
Contact: Céline BORG, MD (0)4 77 82 88 82 ext 33 celine.borg@univ-st-etienne.fr
Contact: Marie PEURIERE (0)4 77 82 92 72 ext 33 marie.peuriere@chu-st-etienne.fr

Locations
France
CHU de Saint Etienne Recruiting
Saint-Étienne, France, 42055
Contact: Céline BORG, MD    (0)4 77 82 88 82 ext 33    celine.borg@univ-st-etienne.fr   
Sub-Investigator: Jean Claude GETENET, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03342339     History of Changes
Other Study ID Numbers: 1708168
2017-A02690-53 ( Other Identifier: ANSM )
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
influence of emotions
positif emotional induction
decision making
Iowa Gambling Task

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases