Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00360009
First received: August 2, 2006
Last updated: October 25, 2012
Last verified: October 2012
Results First Received: August 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Procedure: DBS of the STN
Procedure: DBS of the GPI

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
No Deep Brain Stimuation (DBS) Control Group A control group of PD patients that have not undergone surgical intervention (ie. DBS).
Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)

Participant Flow:   Overall Study
    No Deep Brain Stimuation (DBS) Control Group   Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)   Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
STARTED   10   26   26 
COMPLETED   10   22   23 
NOT COMPLETED   0   4   3 



  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.
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Reporting Groups
  Description
No Deep Brain Stimuation (DBS) Control Group A control group of PD patients that have not undergone surgical intervention (ie. DBS).
Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Total Total of all reporting groups

Baseline Measures
   No Deep Brain Stimuation (DBS) Control Group   Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)   Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   26   26   62 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   5   16   19   40 
>=65 years   5   10   7   22 
Gender 
[Units: Participants]
       
Female   4   8   8   20 
Male   6   18   18   42 
Region of Enrollment 
[Units: Participants]
       
United States   10   26   26   62 


  Outcome Measures
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1.  Primary:   Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

2.  Primary:   Change in Visual Analogue Mood Scales (VAMS) Afraid State   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

3.  Primary:   Change in Visual Analogue Mood Scales (VAMS) Confused State   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

4.  Primary:   Change in Visual Analogue Mood Scales (VAMS) Energetic State   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

5.  Primary:   Change in Visual Analogue Mood Scales (VAMS) Happy State   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

6.  Primary:   Change in Visual Analogue Mood Scales (VAMS) Sad State   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

7.  Primary:   Change in Visual Analogue Mood Scales (VAMS) Tense State   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

8.  Primary:   Change in Visual Analogue Mood Scales (VAMS) Tired State   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

9.  Secondary:   Change in Spielberger State-Trait Anxiety Inventory (STAI)   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

10.  Secondary:   Change in Beck Depression Inventory (BDI)   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]

11.  Secondary:   Change in Letter Fluency Tasks (LFT)   [ Time Frame: Pre-surgery baseline to 6 months of DBS stimulation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Michael Okun, M.D.
Organization: University of Florida Department of Neurology
phone: 352-273-5550
e-mail: okun@neurology.ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00360009     History of Changes
Other Study ID Numbers: 303-2002
K23NS044997 ( US NIH Grant/Contract Award Number )
Study First Received: August 2, 2006
Results First Received: August 5, 2009
Last Updated: October 25, 2012
Health Authority: United States: Federal Government