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Psychiatry Study: Parkinson Disease

NCT02893449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2016-09-08

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

PROCEDURE

Deep brain stimulation

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Raymund Schwan, Prof. · Nancy's Hospital

  • Gérard Barroche, Prof. · CHU of Nancy - Central Hospital - Bd Marechal de Lattre de Tassigny - 54000 Nancy

  • Marie-Christine Tranchant, Prof. · CHU of Strasbourg - 67000 Strasbourg

  • Franck Durif, Prof · CHU Clermont-Ferrand - 63000 Clermont Ferrand

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02893449 on ClinicalTrials.gov