Psychiatry Study: Parkinson Disease

Improvement of Social Adaptation After Pre-operative Cognitive Remediation in Parkinson's Patients Profiting From a Bilateral Subthalamic Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: Social adaptation; Procedure: Deep brain stimulation; Behavioral: Intensive care management

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France, 63003
    • CHU Clermont Ferrand
  • Nancy, France, 54035
    • Chu de Nancy
  • Strasbourg, France, 67426
    • CHRU Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SICRPPD group; (Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation	Behavioral: Social adaptation; Questionnaire to fill-in. 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.; Procedure: Deep brain stimulation
Other: ICM group: Intensive Care Management; Group of patients profiting from a preoperative non structured support	Procedure: Deep brain stimulation; Behavioral: Intensive care management; In this group, the structured program of the SICRPPD group will be replaced by 3 unstructured psychiatric interviews during which patients will be assessed for their perception of the disease and the upcoming surgery. This group will allow to control for the intrinsic effect of the preoperative management independently of the remediation itself.
Other: CG group: Control Group; No supplementary support	Procedure: Deep brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Global score of the SAS SR (social adjustment scale self report) scale	3 months (after surgery)
Global score of the SAS SR (social adjustment scale self report) scale	6 months (after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire)	3 months
Quality of life	evaluated with WHOQOL-bref (World Health Organization Quality of Life)	3 months
Quality of life	evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire)	6 months
Quality of life	evaluated with WHOQOL-bref (World Health Organization Quality of Life)	6 months
Anxiety	evaluated with HAMA (Hamilton Anxiety Rating Scale)	3 months
Anxiety	evaluated with HAMA (Hamilton Anxiety Rating Scale)	6 months
Apathy	evaluated with Starkstein scale	3 months
Apathy	evaluated with Starkstein scale	6 months
Mood	evaluated with Montgomery-Åsberg depression rating scale	3 months
Mood	evaluated with Montgomery-Åsberg depression rating scale	6 months
Global Assessment of Functioning	to rate the social, occupational, and psychological functioning according to psychiatric symptomatology	3 months
Global Assessment of Functioning	to rate the social, occupational, and psychological functioning according to psychiatric symptomatology	6 months
Disease perception	Illness Perception Questionnaire Revised	3 months
Disease perception	Illness Perception Questionnaire Revised	6 months
Perception of deep brain stimulation	with Perception of deep brain stimulation scale	3 months
Perception of deep brain stimulation	with Perception of deep brain stimulation scale	6 months
Coping with disease	with CHIP scale	3 months
Coping with disease	with Brief COPE scale	3 months
Coping with disease	with CHIP scale	6 months
Coping with disease	with Brief COPE scale	6 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Raymund Schwan, Prof., Nancy's Hospital; Principal Investigator: Gérard Barroche, Prof., CHU of Nancy - Central Hospital - Bd Marechal de Lattre de Tassigny - 54000 Nancy; Principal Investigator: Marie-Christine Tranchant, Prof., CHU of Strasbourg - 67000 Strasbourg; Principal Investigator: Franck Durif, Prof, CHU Clermont-Ferrand - 63000 Clermont Ferrand

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 5, 2010
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Parkinson; SAS-SR; Social adaptation; Patients suffering from Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PSY PARKINSON