Parkinson's Disease
Conditions
Keywords
Parkinson, SAS-SR, Social adaptation, Patients suffering from Parkinson's disease
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.
Interventions
BEHAVIORALSocial adaptation
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.
BEHAVIORALIntensive care management
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.
PROCEDUREDeep brain stimulation
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global score of the SAS SR (social adjustment scale self report) scale | 3 months (after surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 3 months | evaluated with HAMA (Hamilton Anxiety Rating Scale) |
| Apathy | 3 months | evaluated with Starkstein scale |
| Mood | 3 months | evaluated with Montgomery-Åsberg depression rating scale |
| Quality of life | 3 months | evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire) |
| Disease perception | 3 months | Illness Perception Questionnaire Revised |
| Perception of deep brain stimulation | 3 months | with Perception of deep brain stimulation scale |
| Coping with disease | 3 months | with CHIP scale |
| Global Assessment of Functioning | 3 months | to rate the social, occupational, and psychological functioning according to psychiatric symptomatology |
Countries
France
Outcome results
None listed