Psychoeducational Programme for PD Patients With STN-DBS
PSYCHE
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedSeptember 18, 2015
September 1, 2015
5.6 years
September 15, 2015
September 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Social adjustment scale
Change from baseline at 1 year after surgery
Secondary Outcomes (6)
Parkinson's disease Questionnaire PDQ-39
Change from baseline at 1 and 2 years after surgery
Anxiety scale (STAI)
Change from baseline at 1 and 2 years after surgery
Mattis dementia rating scale
Change from baseline at 1 and 2 years after surgery
Parkinsonian disability (Unified Parkinson's Disease Rating Scale)
Change from baseline at 1 and 2 years after surgery
Dopaminergic treatment dosage (mg/day)
Change from baseline at 1 and 2 years after surgery
- +1 more secondary outcomes
Study Arms (2)
Psychoeducational programme
EXPERIMENTALPsychoeducational programme
Usual care
NO INTERVENTIONNo psychoeducational programme
Interventions
4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation
Eligibility Criteria
You may qualify if:
- Parkison's disease
- Patients candidate for STN DBS
- Caregiver agreeing to participate
- Signed informed consent
You may not qualify if:
- Contra-indication to STN-DBS
- No caregiver agreeing to participate
- Dementia
- Severe ongoing psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre d'Investigation Clinique GHPS
Paris, Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yannick Vacher
APHP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 18, 2015
Study Start
February 1, 2008
Primary Completion
September 1, 2013
Study Completion
June 1, 2015
Last Updated
September 18, 2015
Record last verified: 2015-09