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Deep Brain Stimulation Follow-up After 10 Years

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ClinicalTrials.gov Identifier: NCT01575132
Recruitment Status : Unknown
Verified November 2012 by University of Aarhus.
Recruitment status was:  Enrolling by invitation
First Posted : April 11, 2012
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease
Parkinson's Disease

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.

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: STN-DBS Retrospective/Prospective Study With a Follow-up Time of Minimum 10 Years
Study Start Date : November 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Parkinson's Disease, DBS, 10-14 years




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All Parkinson-patients treated with Deep Brain Stimulation at Aarhus University Hospital in the years 1998-2002.
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
  • Deceased

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): NCT01575132


Locations
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Denmark
Aarhus University Hospital, Department of Neurology
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Karen Ostergaard, DMSci, PhD Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01575132    
Other Study ID Numbers: 1-10-72-106-12
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: November 2012
Keywords provided by University of Aarhus:
Parkinson's Disease
Stimulation, Deep Brain
Study, Follow-Up
Adverse Effects
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
Synucleinopathies
Neurodegenerative Diseases