- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Toulouse, Francia, 31000
- CHU Toulouse
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: 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:
|
Otro: 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:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Changement of number of mistake during the words generation test
Periodo de tiempo: one hour
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one hour
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
changement of number of uncorrected errors during the Stroop test which reflects the incapacity to inhibit the reading and that evaluates attention
Periodo de tiempo: one hour
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one hour
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christine Brefel, MD, Uh Toulouse
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11 225 02
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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