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NCT Number: NCT02652104

Deep Brain Stimulation in HUCH Region Between 2006 and 2014

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: at six months post-DBS

Secondary outcomes

  1. The possible complications of deep brain stimulation in patient with advanced Parkinson's disease

    Time frame: years

  2. The possible decrease in dosage of anti-Parkinsonian drugs after deep brain stimulation

    Time frame: years

Sponsors and collaborators

Lead sponsor

Hospital District of Helsinki and Uusimaa

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2014
Study completion
2015
First posted
Jan 11, 2016
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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