- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888276
Words Generation in Compulsives Gamblers and Parkinson's Disease Patients (FLUENCE)
Study of Words Generation in Compulsives Gamblers and Healthy Volunteers: Comparison With a Study of Parkinson's Disease Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31000
- CHU Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: healthy volunteers
evaluation of word generation and of motivation
|
Each subject will realize twice each test during 2 sessions with one hour in between : During the session 1 :
During the session 2:
|
Other: compulsive gamblers
evaluation of word generation and of motivation
|
Each subject will realize twice each test during 2 sessions with one hour in between : During the session 1 :
During the session 2:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changement of number of mistake during the words generation test
Time Frame: one hour
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine Brefel, MD, Uh Toulouse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11 225 02
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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