Psychiatry Study: Parkinson Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Social adaptation; Behavioral: Intensive care management; Procedure: Deep brain stimulation

• Registration Number: NCT02893449
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Main objective:

To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation.

Secondary objectives:

To assess in the same patients the impact of structured program of preoperative cognitive remediation on quality of life, mood, anxiety, apathy and psychologic, social and professional functioning depending on psychiatric symptomatology after intervention.

Detailed Description

Prospective, longitudinal, controlled, multicentric, randomised, open study.

Subjects: 3 groups of 40 patients (n=120): one group of patients profiting from a structured program of preoperative cognitive remediation (SICRPPD group: Specific Individual Cognitive Remediation Program in Parkinson's Disease), one group of patients profiting from a preoperative non structured accompaniment (ICM group: Intensive Care Management), one control group (CG group: Control Group).

Required sample size: The sample size of 40 patients/group will allow to demonstrate with a significance threshold of 5% and a power of 80% a difference of evolution of the global SAS SR score of 0.75 SD between 2 of the 3 groups. For an intended SD of 0.2 units, the threshold corresponds to a difference of 0.15 units, minimal significant change.

Intervention: The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program.

Evaluation tools: Patients will be met before and after the intervention for clinical evaluations and scales making: For the psychiatric evaluation: Mini International Neuropsychiatric Inventory (M.I.N.I.), Starkstein Apathy Scale, Montgomery and Asberg depression scale (MADRS), global functioning evaluation scale (EGF) and Hamilton anxiety scale (HAMA)/ For the social adaptation evaluation: Social Adjustment scale Self Report (SAS SR)/ For quality of life evaluation: 39-item Parkinson's Disease Questionnaire (PDQ-39)/ For the daily life activities, 'motor' symptomatology and treatment complications evaluation: Unified Parkinson's Disease Rating Scale (UPDRS, parties II, III, et IV).

Main criteria: change in the global score of the SAS SR scale.

Secondary Criteria: change in scores of the PDQ-39 (quality of life), HAMA (anxiety), Starkstein (apathy), MADRS (mood), EGF (psychologic, social, professional functioning, and depending on the psychiatric symptomatology) questionnaires.

Statistics: parametric and non parametric tests will be done for p \< 0.05.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-02-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-02
• Last Update Submitted: 2016-09-02
• Study First Posted: 2016-09-08
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Men or women suffering from idiopathic Parkinson's disease for which the indication of treatment by deep cerebral stimulation is retained
• Obtained informed consent

Exclusion Criteria

• Absence of social security
• Patient unable to be compliant
• Major patient under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SICRPPD group	Social adaptation	(Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation
ICM group: Intensive Care Management	Intensive care management	Group of patients profiting from a preoperative non structured support
ICM group: Intensive Care Management	Deep brain stimulation	Group of patients profiting from a preoperative non structured support
SICRPPD group	Deep brain stimulation	(Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation
CG group: Control Group	Deep brain stimulation	No supplementary support

Primary Outcome Measures

Name	Time	Method
Global score of the SAS SR (social adjustment scale self report) scale	6 months (after surgery)

Secondary Outcome Measures

Name	Time	Method
Quality of life	6 months	evaluated with WHOQOL-bref (World Health Organization Quality of Life)
Perception of deep brain stimulation	6 months	with Perception of deep brain stimulation scale
Disease perception	6 months	Illness Perception Questionnaire Revised
Coping with disease	6 months	with Brief COPE scale
Anxiety	6 months	evaluated with HAMA (Hamilton Anxiety Rating Scale)
Apathy	6 months	evaluated with Starkstein scale
Mood	6 months	evaluated with Montgomery-Åsberg depression rating scale
Global Assessment of Functioning	6 months	to rate the social, occupational, and psychological functioning according to psychiatric symptomatology

Trial Locations

Locations (3)

CHU Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHRU Strasbourg; 🇫🇷 Strasbourg, France

CHU de Nancy; 🇫🇷 Nancy, France