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Deep Brain Stimulation in HUCH Region Between 2006 and 2014

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ClinicalTrials.gov Identifier: NCT02652104
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Maija Koivu, Hospital District of Helsinki and Uusimaa

Brief 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.

Condition or disease
Parkinson's Disease

Detailed 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 140 participants
Observational Model: Case-Only
Target Follow-Up Duration: 2 Years
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
Study Start Date : January 2006
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population consist of the patients who have received deep brain stimulation treatment. The patient selection for deep brain stimulation has been done according to a clinical protocol.
Criteria

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

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): NCT02652104


Sponsors and Collaborators
Hospital District of Helsinki and Uusimaa
Investigators
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Study Director: Eero Pekkonen, M.D.,Ph.D. Chief Physician

Additional Information:

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Responsible Party: Maija Koivu, specialising physician, Hospital District of Helsinki and Uusimaa
ClinicalTrials.gov Identifier: NCT02652104     History of Changes
Other Study ID Numbers: Helsinki University Hospital
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by Maija Koivu, Hospital District of Helsinki and Uusimaa:
Advanced
Deep brain stimulation

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