Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease
This study has been completed.
Sponsor:
University of Florida
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
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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
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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 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
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 | |
|---|---|---|---|---|
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Number of Participants
[units: participants] |
10 | 26 | 26 | 62 |
|
Age
[units: participants] |
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| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 16 | 19 | 40 |
| >=65 years | 5 | 10 | 7 | 22 |
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Gender
[units: participants] |
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| Female | 4 | 8 | 8 | 20 |
| Male | 6 | 18 | 18 | 42 |
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Region of Enrollment
[units: participants] |
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| United States | 10 | 26 | 26 | 62 |
Outcome Measures
| 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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
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 |
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| No text entered. |
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
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 |