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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03342339
Other study ID # 1708168
Secondary ID 2017-A02690-53
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2018
Est. completion date February 20, 2020

Study information

Verified date January 2021
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date February 20, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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
viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale
Iowa Gambling Task
Test of Iowa Gambling Task

Locations

Country Name City State
France CHU de Grenoble Alpes Grenoble
France CHU de Saint Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 day 1
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