Parkinson's Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation
Sponsors
Study design
Eligibility
Inclusion criteria
* Parkison's disease * Patients candidate for STN DBS * Caregiver agreeing to participate * Signed informed consent
Exclusion criteria
* Contra-indication to STN-DBS * No caregiver agreeing to participate * Dementia * Severe ongoing psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social adjustment scale | Change from baseline at 1 year after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety scale (STAI) | Change from baseline at 1 and 2 years after surgery | STAI |
| Mattis dementia rating scale | Change from baseline at 1 and 2 years after surgery | mattis dementia rating scale |
| Parkinson's disease Questionnaire PDQ-39 | Change from baseline at 1 and 2 years after surgery | Quality of life |
| Dopaminergic treatment dosage (mg/day) | Change from baseline at 1 and 2 years after surgery | Daily dosage of dopaminergic agents |
| Social adjustment scale | Change from baseline at 2 years after surgery | — |
| Parkinsonian disability (Unified Parkinson's Disease Rating Scale) | Change from baseline at 1 and 2 years after surgery | Unified Parkinson's Disease Rating Scale |
Countries
France