Improvement of Social Adaptation After Pre-operative Cognitive Remediation in Parkinson's Patients Profiting From a Bilateral Subthalamic Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 73
- Locations
- 3
- Primary Endpoint
- Global score of the SAS SR (social adjustment scale self report) scale
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
SICRPPD group
(Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation
Intervention: Deep brain stimulation (Procedure)
SICRPPD group
(Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation
Intervention: Social adaptation (Behavioral)
ICM group: Intensive Care Management
Group of patients profiting from a preoperative non structured support
Intervention: Intensive care management (Behavioral)
ICM group: Intensive Care Management
Group of patients profiting from a preoperative non structured support
Intervention: Deep brain stimulation (Procedure)
CG group: Control Group
No supplementary support
Intervention: Deep brain stimulation (Procedure)
Outcomes
Primary Outcomes
Global score of the SAS SR (social adjustment scale self report) scale
Time Frame: 6 months (after surgery)
Global score of the SAS SR (social adjustment scale self report) scale
Time Frame: 3 months (after surgery)
Secondary Outcomes
- Quality of life(6 months)
- Coping with disease(6 months)
- Perception of deep brain stimulation(6 months)
- Global Assessment of Functioning(6 months)
- Disease perception(6 months)
- Anxiety(6 months)
- Apathy(6 months)
- Mood(6 months)
- Quality of life(3 months)
- Anxiety(3 months)
- Apathy(3 months)
- Mood(3 months)
- Global Assessment of Functioning(3 months)
- Disease perception(3 months)
- Perception of deep brain stimulation(3 months)
- Coping with disease(3 months)