NCT03342339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 8, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

November 10, 2017

Last Update Submit

January 15, 2021

Conditions

Parkinson Disease

Keywords

influence of emotionspositif emotional inductiondecision makingIowa Gambling Task

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

patients with Parkinson's disease

OTHER

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 examinationOther: viewing of videoOther: Iowa Gambling Task

witnesses

OTHER

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 examinationOther: viewing of videoOther: Iowa Gambling Task

Interventions

cognitive examinationOTHER

mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test

patients with Parkinson's diseasewitnesses
viewing of videoOTHER

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

patients with Parkinson's diseasewitnesses
Iowa Gambling TaskOTHER

Test of Iowa Gambling Task

patients with Parkinson's diseasewitnesses

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • other neurological or psychiatric antecedents
  • anxio-depressive symptomatology
  • delusional or psychotic state
  • matched in age and sex
  • Vision and hearing normal or successfully corrected
  • Understand the French language
  • general level in the test standard
  • neurological or psychiatric diseases
  • anxio-depressive symptomatology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Grenoble Alpes

Grenoble, France

Location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 14, 2017

Study Start

February 8, 2018

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)