Clinical Trials Logo

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.


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT02893449
Study type Interventional
Source Central Hospital, Nancy, France
Contact
Status Completed
Phase N/A
Start date April 2009
Completion date November 2015

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02915848 - Long-term Stability of LFP Recorded From the STN and the Effects of DBS N/A
Terminated NCT02688465 - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). Phase 4
Completed NCT02562768 - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease Phase 1
Completed NCT00105508 - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia Phase 3
Completed NCT00105521 - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia Phase 3
Completed NCT02236260 - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation N/A
Recruiting NCT03462680 - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures N/A
Recruiting NCT02937324 - The CloudUPDRS Smartphone Software in Parkinson's Study. N/A
Recruiting NCT02927691 - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial Phase 2
Recruiting NCT02952391 - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol N/A
Recruiting NCT02924194 - Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease N/A
Active, not recruiting NCT02874274 - Vaccination Uptake (VAX) in PD N/A
Terminated NCT02894567 - Evaluation of Directional Recording and Stimulation Using spiderSTN N/A
Completed NCT02939391 - A Study of KW-6356 in Subjects With Early Parkinson's Disease Phase 2
Withdrawn NCT02438033 - Characterizing the Specificity and Stability of Local Field Potentials in the Globus Pallidus Internus of Patients Undergoing Deep Brain Stimulation for Parkinson's Disease Phase 1
Completed NCT02523807 - Tremor Monitoring Device N/A
Recruiting NCT02251808 - Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease N/A
Recruiting NCT02837172 - Diagnosis of PD and PD Progression Using DWI
Recruiting NCT02777060 - Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures N/A
Recruiting NCT02347254 - ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease N/A