NCT01888276

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

February 20, 2012

Last Update Submit

June 10, 2015

Conditions

Keywords

Words generation, compulsive gamblers

Outcome Measures

Primary Outcomes (1)

  • Changement of number of mistake during the words generation test

    one hour

Secondary Outcomes (1)

  • changement of number of uncorrected errors during the Stroop test which reflects the incapacity to inhibit the reading and that evaluates attention

    one hour

Study Arms (2)

healthy volunteers

OTHER

evaluation of word generation and of motivation

Other: evaluation of word generation and of motivation

compulsive gamblers

OTHER

evaluation of word generation and of motivation

Other: evaluation of word generation and of motivation

Interventions

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 gamblershealthy volunteers

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christine Brefel, MD

    UH Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 20, 2012

First Posted

June 27, 2013

Study Start

February 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations