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Completed

NCT Number: NCT02554370

Psychoeducational Programme for PD Patients With STN-DBS

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Investigation Clinique GHPS

Paris, 75013, France

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducational Programme

Behavioral

4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation

Primary outcomes

  1. Social adjustment scale

    Time frame: Change from baseline at 1 year after surgery

Secondary outcomes

  1. Parkinson's disease Questionnaire PDQ-39

    Time frame: Change from baseline at 1 and 2 years after surgery

    Quality of life

  2. Anxiety scale (STAI)

    Time frame: Change from baseline at 1 and 2 years after surgery

    STAI

  3. Mattis dementia rating scale

    Time frame: Change from baseline at 1 and 2 years after surgery

    mattis dementia rating scale

  4. Parkinsonian disability (Unified Parkinson's Disease Rating Scale)

    Time frame: Change from baseline at 1 and 2 years after surgery

    Unified Parkinson's Disease Rating Scale

  5. Dopaminergic treatment dosage (mg/day)

    Time frame: Change from baseline at 1 and 2 years after surgery

    Daily dosage of dopaminergic agents

  6. Social adjustment scale

    Time frame: Change from baseline at 2 years after surgery

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Psychoeducational Programme for Patients With Parkinson's Disease Undergoing Subthalamic Deep Brain Stimulation

Acronym: PSYCHE

Important dates

Study start
2008
Primary completion
2013
Study completion
2015
First posted
Sep 18, 2015
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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