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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893449
Other study ID # PSY PARKINSON
Secondary ID
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


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
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