Back to resultsWords Generation in Compulsives Gamblers and Parkinson's Disease Patients (FLUENCE)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
evaluation of word generation and of motivation
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring Words generation, compulsive gamblers
Eligibility Criteria
Inclusion Criteria:
For healthy volunteers :
- Subject from 30 to 75 years old (Male and female)
- Subject with French mother tongue
- Subject who give their informed and signed consent.
- Subject affiliated to a social protection program
For compulsive gamblers :
- Subject from 30 to 75 years old (Male and female)
- Subject with French mother tongue
- Subject with at least 5 criteria of 10 DSM IV diagnostic criteria for pathological gambling
- Subject who give their informed and signed consent.
- Subject affiliated to a social protection program
Exclusion Criteria:
For healthy volunteers and compulsive gamblers :
- Presence of apathy defined as a score greater or equal to 14 on the scale of Starkstein
- Presence of severe depression defined as a score greater or equal to 25 on the scale BDI (Beck Depression Inventory)
- Presence of dementia defined as a score below 25 on the MMSE
- Subject with vision problems making it impossible for the tests
- Pregnant women
- Subject under tutelage, curatelle or law protection
- Subject included in an other clinical study
Sites / Locations
- CHU toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
healthy volunteers
compulsive gamblers
Arm Description
evaluation of word generation and of motivation
evaluation of word generation and of motivation
Outcomes
Primary Outcome Measures
Changement of number of mistake during the words generation test
Secondary Outcome Measures
changement of number of uncorrected errors during the Stroop test which reflects the incapacity to inhibit the reading and that evaluates attention
Full Information
NCT ID
NCT01888276
First Posted
February 20, 2012
Last Updated
June 10, 2015
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT01888276
Brief Title
Words Generation in Compulsives Gamblers and Parkinson's Disease Patients
Acronym
FLUENCE
Official Title
Study of Words Generation in Compulsives Gamblers and Healthy Volunteers: Comparison With a Study of Parkinson's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The pathophysiology of compulsive disorders as gambling could be close to behavior problems encountered in Parkinson's disease associated with a hyperactivity of the motivational system.
Thanks to the words generation test, which reflects the cortico-subcortical loop functioning, involved in motivation, we want to evaluate and compare using tools (words generation and behavioral tests) the motivational functioning of gamblers and healthy volunteers that we can then compare to that of Parkinson's patients with and without behavioral hyperdopaminergic disorders which were explored in another study.
Detailed Description
The main objective of this study is to evaluate performance during words generation in gamblers and healthy volunteers compare to those of PD patients with and without hyper-dopaminergic behaviors collected during another study.
2 groups of subjects will be recruited for the study: 20 compulsive gamblers and 20 healthy volunteers
Each subject will realize twice each test during 2 sessions with one hour in between :
During the session 1 :
The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
The test of Stroop that assesses selective attention
During the session 2:
The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
The task of the casino (Iowa Gambling Test)
The task of landing
The test of Stroop
We supposed that the performance of compulsive gamblers in words generation test will be higher than those of healthy volunteers, themselves superior to those of PD patients with a hyper-dopaminergic behavior, themselves superior to those of PD patient without hyper-dopaminergic behavior.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Words generation, compulsive gamblers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy volunteers
Arm Type
Other
Arm Description
evaluation of word generation and of motivation
Arm Title
compulsive gamblers
Arm Type
Other
Arm Description
evaluation of word generation and of motivation
Intervention Type
Other
Intervention Name(s)
evaluation of word generation and of motivation
Intervention Description
Each subject will realize twice each test during 2 sessions with one hour in between :
During the session 1 :
The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
The test of Stroop that assesses selective attention
During the session 2:
The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
The task of the casino (Iowa Gambling Test)
The task of landing
The test of Stroop
Primary Outcome Measure Information:
Title
Changement of number of mistake during the words generation test
Time Frame
one hour
Secondary Outcome Measure Information:
Title
changement of number of uncorrected errors during the Stroop test which reflects the incapacity to inhibit the reading and that evaluates attention
Time Frame
one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For healthy volunteers :
Subject from 30 to 75 years old (Male and female)
Subject with French mother tongue
Subject who give their informed and signed consent.
Subject affiliated to a social protection program
For compulsive gamblers :
Subject from 30 to 75 years old (Male and female)
Subject with French mother tongue
Subject with at least 5 criteria of 10 DSM IV diagnostic criteria for pathological gambling
Subject who give their informed and signed consent.
Subject affiliated to a social protection program
Exclusion Criteria:
For healthy volunteers and compulsive gamblers :
Presence of apathy defined as a score greater or equal to 14 on the scale of Starkstein
Presence of severe depression defined as a score greater or equal to 25 on the scale BDI (Beck Depression Inventory)
Presence of dementia defined as a score below 25 on the MMSE
Subject with vision problems making it impossible for the tests
Pregnant women
Subject under tutelage, curatelle or law protection
Subject included in an other clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Brefel, MD
Organizational Affiliation
UH Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
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Words Generation in Compulsives Gamblers and Parkinson's Disease Patients
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