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Words Generation in Compulsives Gamblers and Parkinson's Disease Patients (FLUENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888276
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: evaluation of word generation and of motivation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Words Generation in Compulsives Gamblers and Healthy Volunteers: Comparison With a Study of Parkinson's Disease Patients
Study Start Date : February 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
healthy volunteers
evaluation of word generation and of motivation
Other: 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 :

  • 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

compulsive gamblers
evaluation of word generation and of motivation
Other: 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 :

  • 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 Measures :
  1. Changement of number of mistake during the words generation test [ Time Frame: one hour ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888276


Locations
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France
CHU toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Christine Brefel, MD UH Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01888276    
Other Study ID Numbers: 11 225 02
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Keywords provided by University Hospital, Toulouse:
Words generation, compulsive gamblers
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases