Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial

This study has been completed.
Sponsor:
Collaborators:
Medtronic
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01076452
First received: February 24, 2010
Last updated: November 26, 2013
Last verified: November 2013
Results First Received: September 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Intervention: Device: Bilateral Deep Brain Stimulation

  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
299 subjects were enrolled into the study from May 2002 to September 2006 at 13 clinical sites including 7 VA Medical Centers and 6 affiliated university medical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable.

Reporting Groups
  Description
Arm 1

STN (Subthalamic Nucleus)

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.

Arm 2

GPi (Globus Pallidus)

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.


Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     147     152  
COMPLETED     123     138  
NOT COMPLETED     24     14  



  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
Arm 1

STN (Subthalamic Nucleus)

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.

Arm 2

GPi (Globus Pallidus)

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.

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  147     152     299  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     113     117     230  
>=65 years     34     35     69  
Age  
[units: years]
Mean ± Standard Deviation
  61.9  ± 8.7     61.8  ± 8.7     61.8  ± 8.6  
Gender  
[units: participants]
     
Female     31     19     50  
Male     116     133     249  
Region of Enrollment  
[units: participants]
     
United States     147     152     299  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication.   [ Time Frame: Baseline and 24 months ]

2.  Secondary:   The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months.   [ Time Frame: Baseline and 24 months ]

3.  Secondary:   The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months.   [ Time Frame: Baseline and 24 months ]

4.  Secondary:   The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months.   [ Time Frame: Baseline and 24 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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
We observed differences between STN and GPi DBS groups on several secondary measures but these findings should be interpreted cautiously. We did not adjust for repeated significance tests and the differences may have limited clinical significance.  


Results Point of Contact:  
Name/Title: Frances M. Weaver, Ph.D
Organization: Hines Veterans Affairs Hospital Center for Management of Complex Chronic Care
phone: 708-202-8387 ext 25866
e-mail: frances.weaver@va.gov


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01076452     History of Changes
Other Study ID Numbers: 468 Phase II, VA-NINDS-01
Study First Received: February 24, 2010
Results First Received: September 11, 2013
Last Updated: November 26, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration