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

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

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

Study Overview

• Status: Completed
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 420

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Moro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Unified Parkinson's Disease Rating Scale (UPDRS) section I, II, III, IV, V, VI scores	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	pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients that developed Treatment-Related (drug-related or DBS-related) complications	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.	1 year after bilateral Subthalamic Nucleus Deep Brain Stimulation
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)	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.	pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation
Changes in the Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II, III, IV scores	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	pre-operative evaluation, 1-year after Subthalamic Nucleus Deep Brain Stimulation

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Francesco Cavallieri, MD, CHU Grenoble Alpes; Study Director: Elena Moro, MD, PhD, CHU Grenoble Alpes

Publications and helpful links

General Publications

• Weaver FM, Follett K, Stern M, Hur K, Harris C, Marks WJ Jr, Rothlind J, Sagher O, Reda D, Moy CS, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein J, Stoner G, Heemskerk J, Huang GD; CSP 468 Study Group. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial. JAMA. 2009 Jan 7;301(1):63-73. doi: 10.1001/jama.2008.929.
• Kleiner-Fisman G, Herzog J, Fisman DN, Tamma F, Lyons KE, Pahwa R, Lang AE, Deuschl G. Subthalamic nucleus deep brain stimulation: summary and meta-analysis of outcomes. Mov Disord. 2006 Jun;21 Suppl 14:S290-304. doi: 10.1002/mds.20962.
• Moro E, Lozano AM, Pollak P, Agid Y, Rehncrona S, Volkmann J, Kulisevsky J, Obeso JA, Albanese A, Hariz MI, Quinn NP, Speelman JD, Benabid AL, Fraix V, Mendes A, Welter ML, Houeto JL, Cornu P, Dormont D, Tornqvist AL, Ekberg R, Schnitzler A, Timmermann L, Wojtecki L, Gironell A, Rodriguez-Oroz MC, Guridi J, Bentivoglio AR, Contarino MF, Romito L, Scerrati M, Janssens M, Lang AE. Long-term results of a multicenter study on subthalamic and pallidal stimulation in Parkinson's disease. Mov Disord. 2010 Apr 15;25(5):578-86. doi: 10.1002/mds.22735.
• Castrioto A, Lozano AM, Poon YY, Lang AE, Fallis M, Moro E. Ten-year outcome of subthalamic stimulation in Parkinson disease: a blinded evaluation. Arch Neurol. 2011 Dec;68(12):1550-6. doi: 10.1001/archneurol.2011.182. Epub 2011 Aug 8.
• Guehl D, Cuny E, Benazzouz A, Rougier A, Tison F, Machado S, Grabot D, Gross C, Bioulac B, Burbaud P. Side-effects of subthalamic stimulation in Parkinson's disease: clinical evolution and predictive factors. Eur J Neurol. 2006 Sep;13(9):963-71. doi: 10.1111/j.1468-1331.2006.01405.x.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Actual): May 4, 2018
• Study Completion (Actual): January 27, 2019

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Parkinson Disease; Deep Brain Stimulation; Predictive factors; Subthalamic Nucleus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 38RC17.272; 2092048 (Other Identifier: CNIL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No