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

This study has been completed.
Sponsor:
Collaborator:
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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  
Number of Participants  
[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


No publications provided


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