Psychiatry Study: Parkinson Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Social adaptation
* Behavioral: Intensive care management
* Procedure: Deep brain stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SICRPPD group<br>(Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation | Behavioral: Social adaptation<br>* 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.<br>Procedure: Deep brain stimulation<br> <br> |
| Other: ICM group: Intensive Care Management<br>Group of patients profiting from a preoperative non structured support | Behavioral: Intensive care management<br>* 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.<br>Procedure: Deep brain stimulation<br> <br> |
| Other: CG group: Control Group<br>No supplementary support | Procedure: Deep brain stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire) | 3 months | 
| Quality of life | evaluated with WHOQOL-bref (World Health Organization Quality of Life) | 3 months | 
| Quality of life | evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire) | 6 months | 
| Quality of life | evaluated with WHOQOL-bref (World Health Organization Quality of Life) | 6 months | 
| Anxiety | evaluated with HAMA (Hamilton Anxiety Rating Scale) | 3 months | 
| Anxiety | evaluated with HAMA (Hamilton Anxiety Rating Scale) | 6 months | 
| Apathy | evaluated with Starkstein scale | 3 months | 
| Apathy | evaluated with Starkstein scale | 6 months | 
| Mood | evaluated with Montgomery-Åsberg depression rating scale | 3 months | 
| Mood | evaluated with Montgomery-Åsberg depression rating scale | 6 months | 
| Global Assessment of Functioning | to rate the social, occupational, and psychological functioning according to psychiatric symptomatology | 3 months | 
| Global Assessment of Functioning | to rate the social, occupational, and psychological functioning according to psychiatric symptomatology | 6 months | 
| Disease perception | Illness Perception Questionnaire Revised | 3 months | 
| Disease perception | Illness Perception Questionnaire Revised | 6 months | 
| Perception of deep brain stimulation | with Perception of deep brain stimulation scale | 3 months | 
| Perception of deep brain stimulation | with Perception of deep brain stimulation scale | 6 months | 
| Coping with disease | with CHIP scale | 3 months | 
| Coping with disease | with Brief COPE scale | 3 months | 
| Coping with disease | with CHIP scale | 6 months | 
| Coping with disease | with Brief COPE scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson, SAS-SR, Social adaptation, Patients suffering from Parkinson's disease