Trial record 11 of 27 for:
NINDS AND DBS AND Parkinson's
Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial
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| ClinicalTrials.gov Identifier: NCT00056563 |
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Recruitment Status :
Completed
First Posted : March 19, 2003
Results First Posted : July 30, 2013
Last Update Posted : May 9, 2014
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Sponsor:
US Department of Veterans Affairs
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Parkinson's Disease |
| Interventions |
Device: Bilateral Deep Brain Stimulation Other: best medical therapy |
| Enrollment | 255 |
Participant Flow
| Recruitment Details | Patient recruitment begun in May 2002 and the discontinuation of randomization to the BMT arm was approved in August 2005 and participating sites received their IRB approval of this change through October 2005. A total of 255 patients were randomized to either BMT or DBS from 7 VA medical centers and 6 affiliated university sites. |
| Pre-assignment Details | An additional 23 patients were screened after signing the informed consent form but not randomized. 11 of them weren't willing to participate in the follow-up visits after intervention, 7 of them had neuropsychological dysfunction, 2 of them were not responsive to levodopa, and 3 had medical contraindication to surgery and/or DBS stimulation. |
| Arm/Group Title | 1: Bilateral Deep Brain Stimulation | 2: Best Medical Therapy |
|---|---|---|
 Arm/Group Description |
Bilateral Deep Brain Stimulation Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial. |
Best Medical Therapy best medical therapy : Participants will initially be randomized to DBS or to 6 months of |
| Period Title: Overall Study | ||
| Started | 121 | 134 |
| Completed | 121 | 134 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 1: Bilateral Deep Brain Stimulation | 2: Best Medical Therapy | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Bilateral Deep Brain Stimulation Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial. |
Best Medical Therapy best medical therapy : Participants will initially be randomized to DBS or to 6 months of "best medical therapy." BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 121 | 134 | 255 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 121 participants | 134 participants | 255 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
90 74.4%
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97 72.4%
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187 73.3%
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| >=65 years |
31 25.6%
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37 27.6%
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68 26.7%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 121 participants | 134 participants | 255 participants | |
| 62.4 (8.8) | 62.3 (9.0) | 62.3 (8.9) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 121 participants | 134 participants | 255 participants | |
| Female |
23 19.0%
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24 17.9%
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47 18.4%
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| Male |
98 81.0%
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110 82.1%
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208 81.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 121 participants | 134 participants | 255 participants |
| 121 | 134 | 255 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
A limitation of this study is that the STN and GPi cases are pooled into a single DBS group. When the study was planned, it was thought that differences between STN and GPi at six months would be small, which was tested during the study analysis.
More Information
Results Point of Contact
| Name/Title: | Frances M. Weaver, Ph.D, Study Investigator |
| Organization: | Center for Management of Complex Chronic Care |
| Phone: | (708) 202-2414 |
| EMail: | Frances.Weaver@va.gov |
Publications of Results:
Weaver FM, Rothlind J, Stern M. Deep Brain Stimulation for Patients with Advanced Parkinson Disease Reply. [Letter to the Editor]. JAMA : the journal of the American Medical Association. 2009 May 20; 301(19):1985.
Follett K, Weaver FM, Stern M. Comment: Deep-brain stimulation for Parkinson's Disease. The New England journal of medicine. 2010 Sep 3; 363(10):988.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VA Office of Research and Development ( US Department of Veterans Affairs ) |
| ClinicalTrials.gov Identifier: | NCT00056563 |
| Obsolete Identifiers: | NCT00101556 |
| Other Study ID Numbers: |
468 Phase I |
| First Submitted: | March 18, 2003 |
| First Posted: | March 19, 2003 |
| Results First Submitted: | May 20, 2013 |
| Results First Posted: | July 30, 2013 |
| Last Update Posted: | May 9, 2014 |