Psychiatry Study: Parkinson Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893449
• Other study ID #: PSY PARKINSON
• Status: Completed
• Phase: N/A
• First received: February 5, 2010
• Last updated: September 2, 2016
• Start date: April 2009
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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.

Procedure:
• Deep brain stimulation

Locations

Country	Name	City	State
France	CHU Clermont Ferrand	Clermont Ferrand
France	CHU de Nancy	Nancy
France	CHRU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global score of the SAS SR (social adjustment scale self report) scale		3 months (after surgery)	No
Primary	Global score of the SAS SR (social adjustment scale self report) scale		6 months (after surgery)	No
Secondary	Quality of life	evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire)	3 months	No
Secondary	Quality of life	evaluated with WHOQOL-bref (World Health Organization Quality of Life)	3 months	No
Secondary	Quality of life	evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire)	6 months	No
Secondary	Quality of life	evaluated with WHOQOL-bref (World Health Organization Quality of Life)	6 months	No
Secondary	Anxiety	evaluated with HAMA (Hamilton Anxiety Rating Scale)	3 months	No
Secondary	Anxiety	evaluated with HAMA (Hamilton Anxiety Rating Scale)	6 months	No
Secondary	Apathy	evaluated with Starkstein scale	3 months	No
Secondary	Apathy	evaluated with Starkstein scale	6 months	No
Secondary	Mood	evaluated with Montgomery-Åsberg depression rating scale	3 months	No
Secondary	Mood	evaluated with Montgomery-Åsberg depression rating scale	6 months	No
Secondary	Global Assessment of Functioning	to rate the social, occupational, and psychological functioning according to psychiatric symptomatology	3 months	No
Secondary	Global Assessment of Functioning	to rate the social, occupational, and psychological functioning according to psychiatric symptomatology	6 months	No
Secondary	Disease perception	Illness Perception Questionnaire Revised	3 months	No
Secondary	Disease perception	Illness Perception Questionnaire Revised	6 months	No
Secondary	Perception of deep brain stimulation	with Perception of deep brain stimulation scale	3 months	No
Secondary	Perception of deep brain stimulation	with Perception of deep brain stimulation scale	6 months	No
Secondary	Coping with disease	with CHIP scale	3 months	No
Secondary	Coping with disease	with Brief COPE scale	3 months	No
Secondary	Coping with disease	with CHIP scale	6 months	No
Secondary	Coping with disease	with Brief COPE scale	6 months	No