Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to improve motor signs and reduce dopaminergic treatment and related motor complications in patients with severe forms of Parkinson's disease (PD). However, psychological disorders and socio-familial maladjustment are less clearly improved with subthalamic stimulation with an aggravation of the social adjustment described in about 1/3 of cases, with work disruption, divorce or familial conflict. The caregivers have also been reported to present negative well-being after surgery with an aggravation of the quality of life. In the present study, the investigators evaluate the effects of a perioperative psychoeducational programme to avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic stimulation, and their caregivers, in a randomized controlled study.
After inclusion, patients (and their caregivers) are randomized into two groups stratified on their preoperative social adjustment scale couple domain score : usual treatment and psychoeducational programme or usual treatment alone (Figure). The psychoeducational programme focuses on 3 domains: 1) neurosurgical procedure and neurological outcome, 2) social life including work, social and familial relationship, 3) couple relationship. The programme consists of 7 sessions with 3 to 4 couples at the same session, except for the 'couple relationship' domain. Each domain is tackled in a two-way manner with information/education proved by the investigator and discussion of the patients' and caregivers' expectations during one session. The following session started with a 'Questions and Answers' on the previous domain and then information on another domain. Four sessions were carried out prior to surgery and 3 after.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
19
4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation
Centre d'Investigation Clinique GHPS
Paris, Paris, France
Social adjustment scale
Time frame: Change from baseline at 1 year after surgery
Parkinson's disease Questionnaire PDQ-39
Quality of life
Time frame: Change from baseline at 1 and 2 years after surgery
Anxiety scale (STAI)
STAI
Time frame: Change from baseline at 1 and 2 years after surgery
Mattis dementia rating scale
mattis dementia rating scale
Time frame: Change from baseline at 1 and 2 years after surgery
Parkinsonian disability (Unified Parkinson's Disease Rating Scale)
Unified Parkinson's Disease Rating Scale
Time frame: Change from baseline at 1 and 2 years after surgery
Dopaminergic treatment dosage (mg/day)
Daily dosage of dopaminergic agents
Time frame: Change from baseline at 1 and 2 years after surgery
Social adjustment scale
Time frame: Change from baseline at 2 years after surgery
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