Deep Brain Stimulation in HUCH Region Between 2006 and 2014

Parkinson's Disease Clinical Trial

Official title:

A Review of the Clinical Outcome of Deep Brain Stimulation in the Patients With Advanced Parkinson's Disease in Helsinki and Uusimaa Hospital Between 2006 to 2014

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652104
• Other study ID #: Helsinki University Hospital
• Status: Completed
• Phase: N/A
• First received: September 27, 2015
• Last updated: January 8, 2016
• Start date: January 2006
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Hospital District of Helsinki and Uusimaa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Advisory Board on Health Care Ethics
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study reviews the outcome of deep brain stimulation treated patients in Helsinki and Uusimaa University Hospital between 2006 and 2014. The aim of the study is to investigate the outcome and possible side effects of deep brain stimulation treatment.

Description:

Deep brain stimulation is a FDA approved method in treating patients with advanced Parkinson's disease when the best medical treatment is insufficient. In this study the aim is to investigate the outcome of deep brain stimulation treated patients in Helsinki and Uusimaa University hospital between 2006 and 2014. This study is a retrospective study based on existing patients' medical records and does not include an intervention in the treatment of an individual patient.

Deep brain stimulation carries the risks of major surgery. A complication risk for a hemorrhage is 1-2 % and for an infection is 3-10%. The aim of this study is to evaluate the complications that have occurred and the possible benefit of deep brain stimulation in deep brain stimulation treated patients with advanced Parkinson's disease.

The gathered data will be processed anonymously and an individual patient cannot be identified. The data will be processed with an appropriate statistical program (SPSS). No data will be given to external parties.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient with advanced Parkinson's disease and given deep brain stimulation according to the best clinical protocol. This study only observes the outcome of given deep brain stimulation and does not affect on the given treatment.

Exclusion Criteria:

• The normal exclusion criteria for deep brain stimulation which are dementia, a significant vascular atrophy seen in brain CAT scan or MRI, Parkinson's disease with non-levodopa response with less than 30 % improvement in levodopa challenge test, disease duration less than 5 years

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital District of Helsinki and Uusimaa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The benefit of deep brain stimulation in the well-being (measured in UPDRS III, H&Y scale) of a patient with advanced Parkinson's disease		at six months post-DBS	No
Secondary	The possible complications of deep brain stimulation in patient with advanced Parkinson's disease		years	No
Secondary	The possible decrease in dosage of anti-Parkinsonian drugs after deep brain stimulation		years	No