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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychoeducational programme | Experimental | Psychoeducational programme |
|
| Usual care | No Intervention | No psychoeducational programme |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducational programme | Behavioral | 4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Social adjustment scale | Change from baseline at 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's disease Questionnaire PDQ-39 | Quality of life | Change from baseline at 1 and 2 years after surgery |
| Anxiety scale (STAI) | STAI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yannick Vacher | APHP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique GHPS | Paris | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Change from baseline at 1 and 2 years after surgery |
| Mattis dementia rating scale | mattis dementia rating scale | Change from baseline at 1 and 2 years after surgery |
| Parkinsonian disability (Unified Parkinson's Disease Rating Scale) | Unified Parkinson's Disease Rating Scale | Change from baseline at 1 and 2 years after surgery |
| Dopaminergic treatment dosage (mg/day) | Daily dosage of dopaminergic agents | Change from baseline at 1 and 2 years after surgery |
| Social adjustment scale | Change from baseline at 2 years after surgery |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |