Psychiatry Study: Parkinson Disease

Improvement of Social Adaptation After Pre-operative Cognitive Remediation in Parkinson's Patients Profiting From a Bilateral Subthalamic Stimulation

Patrocinadores

Patrocinador principal: Central Hospital, Nancy, France

Fuente Central Hospital, Nancy, France
Resumen breve

Main objective:

To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation.

Secondary objectives:

To assess in the same patients the impact of structured program of preoperative cognitive remediation on quality of life, mood, anxiety, apathy and psychologic, social and professional functioning depending on psychiatric symptomatology after intervention.

Descripción detallada

Prospective, longitudinal, controlled, multicentric, randomised, open study.

Subjects: 3 groups of 40 patients (n=120): one group of patients profiting from a structured program of preoperative cognitive remediation (SICRPPD group: Specific Individual Cognitive Remediation Program in Parkinson's Disease), one group of patients profiting from a preoperative non structured accompaniment (ICM group: Intensive Care Management), one control group (CG group: Control Group).

Required sample size: The sample size of 40 patients/group will allow to demonstrate with a significance threshold of 5% and a power of 80% a difference of evolution of the global SAS SR score of 0.75 SD between 2 of the 3 groups. For an intended SD of 0.2 units, the threshold corresponds to a difference of 0.15 units, minimal significant change.

Intervention: The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program.

Evaluation tools: Patients will be met before and after the intervention for clinical evaluations and scales making: For the psychiatric evaluation: Mini International Neuropsychiatric Inventory (M.I.N.I.), Starkstein Apathy Scale, Montgomery and Asberg depression scale (MADRS), global functioning evaluation scale (EGF) and Hamilton anxiety scale (HAMA)/ For the social adaptation evaluation: Social Adjustment scale Self Report (SAS SR)/ For quality of life evaluation: 39-item Parkinson's Disease Questionnaire (PDQ-39)/ For the daily life activities, 'motor' symptomatology and treatment complications evaluation: Unified Parkinson's Disease Rating Scale (UPDRS, parties II, III, et IV).

Main criteria: change in the global score of the SAS SR scale.

Secondary Criteria: change in scores of the PDQ-39 (quality of life), HAMA (anxiety), Starkstein (apathy), MADRS (mood), EGF (psychologic, social, professional functioning, and depending on the psychiatric symptomatology) questionnaires.

Statistics: parametric and non parametric tests will be done for p < 0.05.

Estado general Completed
Fecha de inicio April 2009
Fecha de Terminación November 2015
Fecha de finalización primaria November 2015
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Global score of the SAS SR (social adjustment scale self report) scale 3 months (after surgery)
Global score of the SAS SR (social adjustment scale self report) scale 6 months (after surgery)
Resultado secundario
Medida Periodo de tiempo
Quality of life 3 months
Quality of life 3 months
Quality of life 6 months
Quality of life 6 months
Anxiety 3 months
Anxiety 6 months
Apathy 3 months
Apathy 6 months
Mood 3 months
Mood 6 months
Global Assessment of Functioning 3 months
Global Assessment of Functioning 6 months
Disease perception 3 months
Disease perception 6 months
Perception of deep brain stimulation 3 months
Perception of deep brain stimulation 6 months
Coping with disease 3 months
Coping with disease 3 months
Coping with disease 6 months
Coping with disease 6 months
Inscripción 73
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Social adaptation

Descripción: Questionnaire to fill-in. The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program.

Etiqueta de grupo de brazo: SICRPPD group

Tipo de intervención: Behavioral

Nombre de intervención: Intensive care management

Descripción: In this group, the structured program of the SICRPPD group will be replaced by 3 unstructured psychiatric interviews during which patients will be assessed for their perception of the disease and the upcoming surgery. This group will allow to control for the intrinsic effect of the preoperative management independently of the remediation itself.

Etiqueta de grupo de brazo: ICM group: Intensive Care Management

Tipo de intervención: Procedure

Nombre de intervención: Deep brain stimulation

Elegibilidad

Criterios:

Inclusion Criteria:

- Men or women suffering from idiopathic Parkinson's disease for which the indication of treatment by deep cerebral stimulation is retained

- Obtained informed consent

Exclusion Criteria:

- Absence of social security

- Patient unable to be compliant

- Major patient under guardianship

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
CHU Clermont Ferrand | Clermont Ferrand, 63003, France
CHU de Nancy | Nancy, 54035, France
CHRU Strasbourg | Strasbourg, 67426, France
Ubicacion Paises

France

Fecha de verificación

September 2016

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: SICRPPD group

Tipo: Other

Descripción: (Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation

Etiqueta: ICM group: Intensive Care Management

Tipo: Other

Descripción: Group of patients profiting from a preoperative non structured support

Etiqueta: CG group: Control Group

Tipo: Other

Descripción: No supplementary support

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov