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

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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

Tracking Information
First Submitted Date  ICMJE February 20, 2012
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date June 11, 2015
Study Start Date  ICMJE February 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
Changement of number of mistake during the words generation test [ Time Frame: one hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Words Generation in Compulsives Gamblers and Parkinson's Disease Patients
Official Title  ICMJE Study of Words Generation in Compulsives Gamblers and Healthy Volunteers: Comparison With a Study of Parkinson's Disease Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Parkinson Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • healthy volunteers
    evaluation of word generation and of motivation
    Intervention: Other: evaluation of word generation and of motivation
  • compulsive gamblers
    evaluation of word generation and of motivation
    Intervention: Other: evaluation of word generation and of motivation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2015)
37
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2013)
40
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888276
Other Study ID Numbers  ICMJE 11 225 02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine Brefel, MD UH Toulouse
PRS Account University Hospital, Toulouse
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP