Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00056563
First received: March 18, 2003
Last updated: July 24, 2013
Last verified: July 2013
Results First Received: May 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Device: Bilateral Deep Brain Stimulation
Other: best medical therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
1: Bilateral Deep Brain Stimulation

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.

2: Best Medical Therapy

Best Medical Therapy

best medical therapy : Participants will initially be randomized to DBS or to 6 months of


Participant Flow:   Overall Study
    1: Bilateral Deep Brain Stimulation     2: Best Medical Therapy  
STARTED     121     134  
COMPLETED     121     134  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1: Bilateral Deep Brain Stimulation

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.

2: Best Medical Therapy

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 Total of all reporting groups

Baseline Measures
    1: Bilateral Deep Brain Stimulation     2: Best Medical Therapy     Total  
Number of Participants  
[units: participants]
  121     134     255  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     90     97     187  
>=65 years     31     37     68  
Age  
[units: years]
Mean ± Standard Deviation
  62.4  ± 8.8     62.3  ± 9.0     62.3  ± 8.9  
Gender  
[units: participants]
     
Female     23     24     47  
Male     98     110     208  
Region of Enrollment  
[units: participants]
     
United States     121     134     255  



  Outcome Measures
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1.  Primary:   The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline.   [ Time Frame: at six months ]

2.  Secondary:   The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation   [ Time Frame: at six months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


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
e-mail: Frances.Weaver@va.gov


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00056563     History of Changes
Obsolete Identifiers: NCT00101556
Other Study ID Numbers: 468 Phase I, VA-NINDS-01
Study First Received: March 18, 2003
Results First Received: May 20, 2013
Last Updated: July 24, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration