Controlled Trial of Deep Brain Stimulation in Early Patients With Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT00354133 |
Recruitment Status
: Unknown
Verified August 2011 by German Parkinson Study Group (GPS).
Recruitment status was: Active, not recruiting
First Posted
: July 20, 2006
Last Update Posted
: January 31, 2012
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Sponsor:
German Parkinson Study Group (GPS)
Collaborators:
University of Schleswig-Holstein
Assistance Publique - Hôpitaux de Paris
KKS Netzwerk
Information provided by (Responsible Party):
German Parkinson Study Group (GPS)
Tracking Information | |||||||
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First Submitted Date ICMJE | July 19, 2006 | ||||||
First Posted Date ICMJE | July 20, 2006 | ||||||
Last Update Posted Date | January 31, 2012 | ||||||
Study Start Date ICMJE | July 2006 | ||||||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment. [ Time Frame: 24 months ] | ||||||
Original Primary Outcome Measures ICMJE |
Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment. | ||||||
Change History | Complete list of historical versions of study NCT00354133 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Controlled Trial of Deep Brain Stimulation in Early Patients With Parkinson's Disease | ||||||
Official Title ICMJE | The Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study) | ||||||
Brief Summary | Parkinsons' disease is one of the most disabling chronic neurological diseases. It can be treated sufficiently until motor complications with fluctuations of mobility and dyskinesias develop. The quality of life and the social and occupational functioning is relentlessly deteriorating with longer disease duration once the complications of conservative therapy develop. High-frequency stimulation of the subthalamic nucleus especially improves the motor complications of Parkinson's disease and preliminary data suggest that also the quality of life and psychosocial handicap are improved. So far this therapy is only used for patients which have already undergone personal, professional and social degradation due to motor complications of the disease. The aim of this study is to assess the use of this therapy in earlier stages of the disease, when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. | ||||||
Detailed Description | Patients are randomized either to medical treatment or subthalamic stimulation. The observation period is 2 years. The primary outcome criterium: PDQ-39. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Parkinson Disease | ||||||
Intervention ICMJE | Device: Kinetra and Soletra (neurostimulator, Medtronic)
Arm I: Implantation of stimulation electrodes in the STN and best medical treatment Arm II: Best medical treatment only |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Actual Enrollment ICMJE |
251 | ||||||
Original Enrollment ICMJE |
246 | ||||||
Estimated Study Completion Date | June 2012 | ||||||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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Sex/Gender |
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Ages | 18 Years to 60 Years (Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | France, Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00354133 | ||||||
Other Study ID Numbers ICMJE | A 121/06 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | German Parkinson Study Group (GPS) | ||||||
Study Sponsor ICMJE | German Parkinson Study Group (GPS) | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | German Parkinson Study Group (GPS) | ||||||
Verification Date | August 2011 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |