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Predictive Factors of Short/Long-term Outcome and Complications of Bilateral DBS in PD (PREDIMPSTIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528460
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

The purpose and main objective of this study is the research of pre-operative and operative predictive factors of short-term (1-year) and long-term (15-years) improvement of quality of life, motor and non-motor symptoms in Parkinson's disease patients who have undergone to bilateral Subthalamic Nucleus Deep Brain Stimulation.

The hypothesis of the study is that the definition of pre-operative and operative predictive factors could be able to improve the pre-operative prognostic accuracy of outcome and complications after surgery, allowing also a better selection of the most suitable candidates for bilateral Subthalamic Nucleus Deep Brain Stimulation.

For example, we can suppose that an older age at surgery, elevated axial score, a less preoperative dopa-responsiveness, the presence of mild executive dysfunction at surgery or an unfavourable social status, could negatively influence the short and long term surgery outcome


Condition or disease
Parkinson Disease

Detailed Description:

Subthalamic NucleusDeep Brain Stimulation (STN-DBS) represents a short and long-term effective treatment in Parkinson's disease (PD) patients. Various randomized controlled trials have confirmed the superiority of STN-DBS compared to the best medical treatment in patients with advanced Parkinson disease in term of improvement of motor function and quality of life. On the other hand, STN- DBS is associated with an increased risk of adverse events compared to best medical treatment.

Data from previous meta-analysis have shown that only pre-operative dopa-responsiveness can predict the clinical efficacy and outcome of STN-DBS. In particular the improvement of STN-DBS on quality of life mainly concern the physical aspects of functioning with a lower improvement on social and cognitive aspects.

However, not all of PD symptoms respond similarly to STN-DBS. In particular the effects of STN-DBS on the so-called levodopa unresponsive symptoms (i.e. gait and balance symptoms, autonomic dysfunction, sleep disorders, cognitive decline and speech and swallowing troubles) are modest or absent. Furthermore, levodopa unresponsive symptoms are one of the main causes of impairment and disability in advanced PD patients. Bearing in mind these informations, the clinical phenotyping of candidates for surgery appear crucial for the prediction of DBS outcome and selection of better candidates. In the recent years, several papers highlighted and expanded the list of possible predictive factors, from a motor point of view to non-motor symptoms and psychosocial aspects.

In this setting, the aim of our study is to determine the pre-operative and operative short-term (1-year) and long-term (15-years) predictive factors of improvement of quality of life and motor and non-motor symptoms in a large cohort of PD patients who have undergone to bilateral STN-DBS. The better definition of short-term and long-term predictive factors and its association with the different PD different clinical phenotypes could allow in the future a better definition of the effects of STN-DBS on quality of life and motor and non-motor symptoms in the different PD clinical phenotypes.

In the same way, it could be assumed that a better definition of pre-operative predictive factors of surgical, hardware and stimulation-induced STN-DBS side effects in the short term, could also allow a better definition of the risk-to-benefit ratio and outcome after STN-DBS surgery

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Study Type : Observational
Actual Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Étude Des Facteurs prédictifs Des Effets Cliniques et Des Complications à Court et Long Terme de la Stimulation cérébrale Profonde Des Noyaux Sous-thalamiques Dans la Maladie de Parkinson
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : January 27, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in the Unified Parkinson's Disease Rating Scale (UPDRS) section I, II, III, IV, V, VI scores [ Time Frame: pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) has been developed for the clinical evaluation of Parkinson's disease (PD) patients. It allows the assessment of both motor and non-motor symptoms associated with PD


Secondary Outcome Measures :
  1. Number of Patients that developed Treatment-Related (drug-related or DBS-related) complications [ Time Frame: 1 year after bilateral Subthalamic Nucleus Deep Brain Stimulation ]

    Surgical-related complications, post-operative complications related to DBS devices and hardware, complications related to STN stimulation or drug administration.

    Post-operative complications directly related to STN stimulation.


  2. Changes in the Parkinson's Disease Questionnaire (PDQ-39) total score and different subscale scores (Mobility; Activities of daily living; Emotional well being; Stigma; Social Support; Cognitions; Communication; Bodily discomfort) [ Time Frame: pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation ]
    The Parkinson's Disease Questionnaire (PDQ-39) is a short 39 item self-report health status questionnaire developed for evaluate the quality of life in Parkinson's disease patients.

  3. Changes in the Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II, III, IV scores [ Time Frame: pre-operative evaluation, 1-year after Subthalamic Nucleus Deep Brain Stimulation ]
    The Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the recent version of the UPDRS revised by the MDS. It allows the assessment of both motor and non-motor symptoms associated with PD



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with Parkinson's disease treated with bilateral Subthalamic Nucleus Deep Brain Stimulation
Criteria

Inclusion Criteria:

  • Patients with Parkinson's disease treated with bilateral Subthalamic Nucleus Deep Brain Stimulation

Exclusion Criteria:

  • Patients treated with bilateral Subthalamic Nucleus Deep Brain Stimulation not affected by Parkinson's Disease
  • Patients with Parkinson's disease treated with unilateral Subthalamic Nucleus Deep Brain Stimulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528460


Locations
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France
Moro
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Francesco Cavallieri, MD CHU Grenoble Alpes
Study Director: Elena Moro, MD, PhD CHU Grenoble Alpes
Publications of Results:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03528460    
Other Study ID Numbers: 38RC17.272
2092048 ( Other Identifier: CNIL )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Parkinson Disease
Deep Brain Stimulation
Subthalamic Nucleus
Predictive factors
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases