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

NCT03528460 | Completed

• 2 other identifiers: 38RC17.2722092048
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Deep Brain Stimulation; Subthalamic Nucleus; Predictive factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Patients that developed Treatment-Related (drug-related or DBS-related) complications

  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)

  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

  pre-operative evaluation, 1-year after Subthalamic Nucleus Deep Brain Stimulation

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Moro

Grenoble, 38043, France

Location

Related Publications (5)

• 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.

  PMID: 16892449 RESULT

• 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.

  PMID: 19126811 RESULT

• 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.

  PMID: 20213817 RESULT

• 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.

  PMID: 21825213 RESULT

• 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.

  PMID: 16930362 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Francesco Cavallieri, MD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

• Elena Moro, MD, PhD

  CHU Grenoble Alpes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: May 17, 2018
• Study Start: September 11, 2017
• Primary Completion: May 4, 2018
• Study Completion: January 27, 2019
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)