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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT00360009
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 62
• Location: 1
• Arms: 3
• Duration (Months): 51
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this trial is to study the mood and cognitive effects of deep brain stimulation in Parkinson's disease.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Procedure: DBS of the STN; Procedure: DBS of the GPI	N/A

Detailed Description

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and the globus pallidus interna (GPi) has been shown to relieve the motor symptoms of Parkinson's disease (PD) such as tremor, rigidity, and bradykinesia. However, there is increasing evidence that DBS may be associated with a significant number of mood and cognitive changes.

The aims of this study are to characterize and compare the mood and cognitive effects associated with DBS of the STN and GPi, to delineate regions within or around the STN and GPi that are associated with specific mood and cognitive changes when DBS is applied to these areas, and to assess the relative effectiveness of right versus left STN or GPi stimulation on mood and cognition.

In the study, researchers will compare motor, mood, and cognitive function in people with PD who have had DBS treatment with control subjects (or individuals with PD who have not had DBS). The scientists will characterize the types and incidence of mood and cognitive changes that occur during DBS in each target (STN and GPi), compare the targets, and examine the role of lead location.

The study will enroll 62 participants-10 control subjects (individuals with PD who have not had DBS), and 52 individuals with PD who are scheduled for DBS; the site of the implant (STN or GPi) will be randomly assigned. Participants will perform motor, mood, and cognitive tests (following 6 months of stimulation) over a 2-day period. Duration of the trial for participants is 6 months and includes a 2-night hospital stay.

Findings from this study may help researchers better understand how DBS affects non-motor circuitry.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cognition and Mood in Parkinson's Disease (PD) in Subthalamic Nucleus (STN) Versus Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: STN DBS Patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's disease (PD)	Procedure: DBS of the STN; Patients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device.
Active Comparator: GPI DBS Patients who underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi) to treat Parkinson's disease (PD)	Procedure: DBS of the GPI; Patients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device.
No Intervention: no DBS non-DBS PD patient control group

Outcome Measures

Primary Outcome Measures

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

   VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

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

   VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

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

   VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

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

   VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

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

   VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

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

   VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

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

   VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

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

   VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

Secondary Outcome Measures

1. Change in Spielberger State-Trait Anxiety Inventory (STAI) [Pre-surgery baseline to 6 months of DBS stimulation]

   STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-1.4) indicates a reduction in anxiety from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in anxiety. The larger the absolute T-score value,the greater the mean change in anxiety.

2. Change in Beck Depression Inventory (BDI) [Pre-surgery baseline to 6 months of DBS stimulation]

   BDI is a questionnaire used to measure depression. There is a four-point scale for each of the 21-items of the questionnaire with scores ranging from 0 to 3. Total raw scores range from 0 to 63. The higher the score the greater the severity of depression. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-3.7) indicates a reduction in depression from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in depression. The larger the absolute T-score value,the greater the mean change in depression.

3. Change in Letter Fluency Tasks (LFT) [Pre-surgery baseline to 6 months of DBS stimulation]

   LFT assess frontal lobe function. Performance measure is number of words beginning with a specific letter generated in 1 min. Although no range of possible scores,the more words named in allotted time,the higher the predicted frontal lobe function. Raw score is converted to T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-2.6) signifies a reduction in task performance from pre to post-DBS while a positive T-score difference(0.7) denotes an increase in task performance. The larger the absolute T-score value,the greater the mean change in performance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Intractable, disabling PD with motor fluctuations, dyskinesias, or freezing episodes

• Age between 30-75 years

• Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of anti-Parkinsonian drugs)

• A stable and optimal medical regimen of anti-Parkinsonian drug therapy for at least three months prior to surgery

• Patients must be right-handed to be included in the study since mood and cognition are being analyzed and right hemisphere dominant patients could confound the results.

Exclusion Criteria:

• Clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension)

• Evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension

• MRI scan with significant evidence of brain atrophy or other abnormalities (e.g., lacunar infarcts or iron deposits in the putamen)

• The Mattis Dementia Rating Scale will be used to assess the level of intellectual function and patients will be excluded with scores reflecting clinical dementia

• A major psychiatric disorder on the Structured Clinical Interview for DSM-IV (SCID-IV).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida College of Medicine, Department of Neurology, McKnight Brain Institute, 100 South Newell Drive, L-3 100	Gainesville	Florida	United States	32610-0236

Sponsors and Collaborators

• University of Florida
• National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Michael Okun, MD, University of Florida
• Principal Investigator: Kelly Foote, MD, University of Florida
• Principal Investigator: Hubert Fernandez, MD, University of Florida
• Principal Investigator: Ramon Rodriguez, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT00360009
• Other Study ID Numbers: 303-2002; K23NS044997
• First Posted: Aug 3, 2006
• Last Update Posted: Oct 31, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by University of Florida: Parkinson's disease; Parkinson disease; PD; deep brain stimulation; DBS; subthalamic nucleus; STN; globus pallidus interna; GPi; mood; motor symptoms; cognition; emotion; memory; attention; tremor; rigidity; bradykinesia
• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Period Title: Overall Study
STARTED	10	26	26
COMPLETED	10	22	23
NOT COMPLETED	0	4	3

Baseline Characteristics

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)	Total
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)	Total of all reporting groups
Overall Participants	10	26	26	62
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	5 50%	16 61.5%	19 73.1%	40 64.5%
>=65 years	5 50%	10 38.5%	7 26.9%	22 35.5%
Sex: Female, Male (Count of Participants)
Female	4 40%	8 30.8%	8 30.8%	20 32.3%
Male	6 60%	18 69.2%	18 69.2%	42 67.7%
Region of Enrollment (participants) [Number]
United States	10 100%	26 100%	26 100%	62 100%

Outcome Measures

1. Primary Outcome

Title	Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State
Description	VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	5.3 (10.2)	-0.1 (5.3)

2. Secondary Outcome

Title	Change in Spielberger State-Trait Anxiety Inventory (STAI)
Description	STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-1.4) indicates a reduction in anxiety from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in anxiety. The larger the absolute T-score value,the greater the mean change in anxiety.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	-3.3 (13.4)	0.3 (13.6)

3. Secondary Outcome

Title	Change in Beck Depression Inventory (BDI)
Description	BDI is a questionnaire used to measure depression. There is a four-point scale for each of the 21-items of the questionnaire with scores ranging from 0 to 3. Total raw scores range from 0 to 63. The higher the score the greater the severity of depression. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-3.7) indicates a reduction in depression from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in depression. The larger the absolute T-score value,the greater the mean change in depression.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	-2.8 (6.3)	-4.6 (5.4)

4. Secondary Outcome

Title	Change in Letter Fluency Tasks (LFT)
Description	LFT assess frontal lobe function. Performance measure is number of words beginning with a specific letter generated in 1 min. Although no range of possible scores,the more words named in allotted time,the higher the predicted frontal lobe function. Raw score is converted to T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-2.6) signifies a reduction in task performance from pre to post-DBS while a positive T-score difference(0.7) denotes an increase in task performance. The larger the absolute T-score value,the greater the mean change in performance.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	-5.6 (6.7)	0.3 (10.7)

5. Primary Outcome

Title	Change in Visual Analogue Mood Scales (VAMS) Afraid State
Description	VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	1.3 (16.9)	-2.2 (13.0)

6. Primary Outcome

Title	Change in Visual Analogue Mood Scales (VAMS) Confused State
Description	VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	5.7 (15.4)	1.3 (11.0)

7. Primary Outcome

Title	Change in Visual Analogue Mood Scales (VAMS) Energetic State
Description	VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	-1.4 (12.3)	2.0 (18.7)

8. Primary Outcome

Title	Change in Visual Analogue Mood Scales (VAMS) Happy State
Description	VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	2.9 (17.2)	5.0 (13.8)

9. Primary Outcome

Title	Change in Visual Analogue Mood Scales (VAMS) Sad State
Description	VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	-2.4 (17.8)	-1.0 (13.0)

10. Primary Outcome

Title	Change in Visual Analogue Mood Scales (VAMS) Tense State
Description	VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	-2.0 (17.5)	-8.5 (20.0)

11. Primary Outcome

Title	Change in Visual Analogue Mood Scales (VAMS) Tired State
Description	VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Time Frame	Pre-surgery baseline to 6 months of DBS stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Measure Participants	0	22	23
Mean (Standard Deviation) [T-score]	-8.5 (12.0)	-2.0 (13.5)

Adverse Events

Arm/Group Title	No Deep Brain Stimuation (DBS) Control Group		Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)		Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Arm/Group Description	A control group of PD patients that have not undergone surgical intervention (ie. DBS).		Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)		Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
All Cause Mortality
	No Deep Brain Stimuation (DBS) Control Group		Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)		Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	No Deep Brain Stimuation (DBS) Control Group		Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)		Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		6/26 (23.1%)		8/26 (30.8%)
Infections and infestations
Infection	0/10 (0%)	0	1/26 (3.8%)	1	1/26 (3.8%)	1
Nervous system disorders
Confusion/Disorientation/Difficulty Concentrating/Distractability	0/10 (0%)	0	3/26 (11.5%)	3	2/26 (7.7%)	2
Transient Ischemic Attack	0/10 (0%)	0	1/26 (3.8%)	1	1/26 (3.8%)	1
Symptomatic Hemorrhage	0/10 (0%)	0	0/26 (0%)	0	1/26 (3.8%)	1
Symptomatic Venous Hemorrhage	0/10 (0%)	0	0/26 (0%)	0	2/26 (7.7%)	2
Hemorrhage Resulting in Death	0/10 (0%)	0	1/26 (3.8%)	1	0/26 (0%)	0
Psychiatric disorders
Anxiety/Feafulness/Preocupation with Health	0/10 (0%)	0	0/26 (0%)	0	1/26 (3.8%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia Resulting in Death	0/10 (0%)	0	1/26 (3.8%)	1	0/26 (0%)	0
Air Embolus	0/10 (0%)	0	0/26 (0%)	0	1/26 (3.8%)	1
Other (Not Including Serious) Adverse Events
	No Deep Brain Stimuation (DBS) Control Group		Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)		Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		25/26 (96.2%)		23/26 (88.5%)
Gastrointestinal disorders
Nausea/Vomiting	0/10 (0%)	0	3/26 (11.5%)	3	1/26 (3.8%)	1
Stomach Cramps/Constipation/Indegestion	0/10 (0%)	0	2/26 (7.7%)	2	1/26 (3.8%)	1
General disorders
Fatigue/Tired	0/10 (0%)	0	11/26 (42.3%)	11	3/26 (11.5%)	3
Pain	0/10 (0%)	0	9/26 (34.6%)	9	2/26 (7.7%)	2
Dizziness/Lightheadedness/Orthostasis	0/10 (0%)	0	4/26 (15.4%)	4	2/26 (7.7%)	2
Weakness	0/10 (0%)	0	4/26 (15.4%)	4	1/26 (3.8%)	1
Weight Loss	0/10 (0%)	0	3/26 (11.5%)	3	2/26 (7.7%)	2
Dry Mouth	0/10 (0%)	0	2/26 (7.7%)	2	1/26 (3.8%)	1
Infections and infestations
Cold/Low-grade Fever	0/10 (0%)	0	2/26 (7.7%)	2	1/26 (3.8%)	1
Nervous system disorders
Difficulty with Speech and Language/Increased Speech	0/10 (0%)	0	8/26 (30.8%)	8	10/26 (38.5%)	10
Worsening of Memory	0/10 (0%)	0	2/26 (7.7%)	2	3/26 (11.5%)	3
Sleep Disturbance/Vivid Dreaming/Increased Somnolence	0/10 (0%)	0	14/26 (53.8%)	14	11/26 (42.3%)	11
Worsening of Balance/Gait Disturbance/Freezing	0/10 (0%)	0	6/26 (23.1%)	6	5/26 (19.2%)	5
Headache/Migraine	0/10 (0%)	0	2/26 (7.7%)	2	3/26 (11.5%)	3
Psychiatric disorders
Depression/Tearful/Decreased Confidence/Loss of Motivation/Feelings of Guilt	0/10 (0%)	0	20/26 (76.9%)	20	7/26 (26.9%)	7
Anxiety/Fearfulness/Preoccupation with Health	0/10 (0%)	0	14/26 (53.8%)	14	6/26 (23.1%)	6
Confusion/Disorientation/Difficulty Concentrating/Distractibility	0/10 (0%)	0	7/26 (26.9%)	7	4/26 (15.4%)	4
Irritability/Disruptive of Aggressive Behavior	0/10 (0%)	0	10/26 (38.5%)	10	5/26 (19.2%)	5
Obsessive-Compulsive Tendencies	0/10 (0%)	0	5/26 (19.2%)	5	2/26 (7.7%)	2
Manic Tendencies	0/10 (0%)	0	5/26 (19.2%)	5	1/26 (3.8%)	1
Anorexia	0/10 (0%)	0	1/26 (3.8%)	1	3/26 (11.5%)	3
Renal and urinary disorders
Difficulty with Urination/Urinary Urgency/Distended Bladder	0/10 (0%)	0	1/26 (3.8%)	1	3/26 (11.5%)	3
Reproductive system and breast disorders
Decreased Libido	0/10 (0%)	0	3/26 (11.5%)	3	5/26 (19.2%)	5
Skin and subcutaneous tissue disorders
Pain/Discomfort/Pruritus/Erythema at Sight of Incision	0/10 (0%)	0	3/26 (11.5%)	3	1/26 (3.8%)	1

Limitations/Caveats

[Not Specified]

More Information

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.