- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342339
Influence of Emotions on Decision-making in Parkinson's Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Grenoble, France
- CHU de Grenoble Alpes
-
Saint-Étienne, France, 42055
- CHU de Saint Etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: patients with Parkinson's disease
|
mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale
Test of Iowa Gambling Task
|
Other: witnesses
|
mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale
Test of Iowa Gambling Task
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1708168
- 2017-A02690-53 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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