Deep Brain Stimulation Follow-up After 10 Years
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease|
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|
|Estimated Enrollment :||15 participants|
|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|
|Parkinson's Disease, DBS, 10-14 years|
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
|Aarhus University Hospital, Department of Neurology|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Karen Ostergaard, DMSci, PhD||Aarhus University Hospital|