Clinical trial NCT02893449: Psychiatry Study: Parkinson Disease
Official title: Improvement of Social Adaptation After Pre-operative Cognitive Remediation in Parkinson's Patients Profiting From a Bilateral Subthalamic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson
SAS-SR
Social adaptation
Patients suffering from Parkinson's disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Global score of the SAS SR (social adjustment scale self report) scale
timeFrame: 3 months (after surgery)
measure: Global score of the SAS SR (social adjustment scale self report) scale
timeFrame: 6 months (after surgery)
Secondary outcomes:
measure: Quality of life
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Quality of life
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Anxiety
timeFrame: 3 months
measure: Anxiety
timeFrame: 6 months
measure: Apathy
timeFrame: 3 months
measure: Apathy
timeFrame: 6 months
measure: Mood
timeFrame: 3 months
measure: Mood
timeFrame: 6 months
measure: Global Assessment of Functioning
timeFrame: 3 months
measure: Global Assessment of Functioning
timeFrame: 6 months
measure: Disease perception
timeFrame: 3 months
measure: Disease perception
timeFrame: 6 months
measure: Perception of deep brain stimulation
timeFrame: 3 months
measure: Perception of deep brain stimulation
timeFrame: 6 months
measure: Coping with disease
timeFrame: 3 months
measure: Coping with disease
timeFrame: 3 months
measure: Coping with disease
timeFrame: 6 months
measure: Coping with disease
timeFrame: 6 months
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Nancy
country: France
facility: CHU de Nancy
city: Strasbourg
country: France
facility: CHRU Strasbourg
Study officials:
affiliation: Nancy's Hospital
name: Raymund Schwan, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU of Nancy - Central Hospital - Bd Marechal de Lattre de Tassigny - 54000 Nancy
name: Gérard Barroche, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU of Strasbourg - 67000 Strasbourg
name: Marie-Christine Tranchant, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Clermont-Ferrand - 63000 Clermont Ferrand
name: Franck Durif, Prof
role: PRINCIPAL_INVESTIGATOR
References: