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Clinical Trials/NCT01575132
NCT01575132
Unknown
Not Applicable

STN-DBS Retrospective/Prospective Study With a Follow-up Time of Minimum 10 Years

University of Aarhus1 site in 1 country15 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
University of Aarhus
Enrollment
15
Locations
1
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS) for patients with Parkinson's Disease. We have data for patients operated with DBS since 1998. We wish to examine the effect of stimulation on motor symptoms as well as make a follow-up on complications and side-effects related to treatment. We also wish to follow-up on the quality of life-studies made in the years 2003-2008.

Detailed Description

Parkinson's Disease (PD) is caused by a progressive loss of dopamine-producing cells in substantia nigra in mesencephalon. PD is characterized by the symptoms resting tremor, rigidity and bradykinesia. Later in the course of the disease, patients develop gait- and balance symptoms. In the first years of the disease, the patients' symptoms are treated well with levodopa. As the disease develops and the loss of dopamine-producing cells grows, the physiological buffer-capacity for levodopa is lost and patients develop motor fluctuations in the shape of on-off symptoms and dyskinesias. Patients with these symptoms may benefit from implantation of electrodes in the subthalamic nucleus, which is stimulated by an pulse generator on the chest. A number of studies have found a long-term effect of DBS, but most of these studies have a follow-up time of no more than five years. Overall, these studies show a beneficial effect of DBS after five years: The patients need less medication, the number of off-periods is decreased and they score lower on the Unified Parkinson Disease Rating Scale, part three. However, the axial symptoms and the bradykinesia progress. As of yet, few studies examine the effect of Deep Brain Stimulation after 10 years. In our study we wish to examine the effect of DBS for all patients operated at Aarhus University Hospital in the years 1998-2002, which gives us a follow-up time of 10-14 years.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
September 2015
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with Parkinson's Disease treated with DBS at Aarhus University Hospital in the years 1998-2002.

Exclusion Criteria

  • Dementia, i.e. MMSE\<24
  • DBS removed

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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