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Completed

NCT Number: NCT02893449

Psychiatry Study: Parkinson Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont Ferrand, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Social adaptation

Behavioral

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

Behavioral

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.

Deep Brain Stimulation

Procedure

Primary outcomes

  1. Global score of the SAS SR (social adjustment scale self report) scale

    Time frame: 3 months (after surgery)

  2. Global score of the SAS SR (social adjustment scale self report) scale

    Time frame: 6 months (after surgery)

Secondary outcomes

  1. Quality of life

    Time frame: 3 months

    evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire)

  2. Quality of life

    Time frame: 3 months

    evaluated with WHOQOL-bref (World Health Organization Quality of Life)

  3. Quality of life

    Time frame: 6 months

    evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire)

  4. Quality of life

    Time frame: 6 months

    evaluated with WHOQOL-bref (World Health Organization Quality of Life)

  5. Anxiety

    Time frame: 3 months

    evaluated with HAMA (Hamilton Anxiety Rating Scale)

  6. Anxiety

    Time frame: 6 months

    evaluated with HAMA (Hamilton Anxiety Rating Scale)

  7. Apathy

    Time frame: 3 months

    evaluated with Starkstein scale

  8. Apathy

    Time frame: 6 months

    evaluated with Starkstein scale

  9. Mood

    Time frame: 3 months

    evaluated with Montgomery-Åsberg depression rating scale

  10. Mood

    Time frame: 6 months

    evaluated with Montgomery-Åsberg depression rating scale

  11. Global Assessment of Functioning

    Time frame: 3 months

    to rate the social, occupational, and psychological functioning according to psychiatric symptomatology

  12. Global Assessment of Functioning

    Time frame: 6 months

    to rate the social, occupational, and psychological functioning according to psychiatric symptomatology

  13. Disease perception

    Time frame: 3 months

    Illness Perception Questionnaire Revised

  14. Disease perception

    Time frame: 6 months

    Illness Perception Questionnaire Revised

  15. Perception of deep brain stimulation

    Time frame: 3 months

    with Perception of deep brain stimulation scale

  16. Perception of deep brain stimulation

    Time frame: 6 months

    with Perception of deep brain stimulation scale

  17. Coping with disease

    Time frame: 3 months

    with CHIP scale

  18. Coping with disease

    Time frame: 3 months

    with Brief COPE scale

  19. Coping with disease

    Time frame: 6 months

    with CHIP scale

  20. Coping with disease

    Time frame: 6 months

    with Brief COPE scale

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Sep 8, 2016
Registry last updated
Sep 8, 2016

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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