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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

Tracking Information
First Submitted Date April 10, 2012
First Posted Date April 11, 2012
Last Update Posted Date December 11, 2013
Study Start Date November 2012
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Deep Brain Stimulation Follow-up After 10 Years
Official Title STN-DBS Retrospective/Prospective Study With a Follow-up Time of Minimum 10 Years
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All Parkinson-patients treated with Deep Brain Stimulation at Aarhus University Hospital in the years 1998-2002.
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts Parkinson's Disease, DBS, 10-14 years
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 10, 2012)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2015
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
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
  • Deceased
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01575132
Other Study ID Numbers 1-10-72-106-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Karen Ostergaard, DMSci, PhD Aarhus University Hospital
PRS Account University of Aarhus
Verification Date November 2012