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| ID | Type | Description | Link |
|---|---|---|---|
| K23NS044997 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this trial is to study the mood and cognitive effects of deep brain stimulation in Parkinson's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STN DBS | Active Comparator | Patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's disease (PD) |
|
| GPI DBS | Active Comparator | Patients who underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi) to treat Parkinson's disease (PD) |
|
| no DBS | No Intervention | non-DBS PD patient control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBS of the STN | Procedure | Patients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Change in Visual Analogue Mood Scales (VAMS) Afraid State | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Change in Visual Analogue Mood Scales (VAMS) Confused State | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spielberger State-Trait Anxiety Inventory (STAI) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Medicine, Department of Neurology, McKnight Brain Institute, 100 South Newell Drive, L-3 100 | Gainesville | Florida | 32610-0236 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Deep Brain Stimuation (DBS) Control Group | A control group of PD patients that have not undergone surgical intervention (ie. DBS). |
| FG001 | Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) | Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD) |
| FG002 | Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) | Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Deep Brain Stimuation (DBS) Control Group | A control group of PD patients that have not undergone surgical intervention (ie. DBS). |
| BG001 | Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State | 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. | Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Deep Brain Stimuation (DBS) Control Group | A control group of PD patients that have not undergone surgical intervention (ie. DBS). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusion/Disorientation/Difficulty Concentrating/Distractability | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression/Tearful/Decreased Confidence/Loss of Motivation/Feelings of Guilt | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Okun, M.D. | University of Florida Department of Neurology | 352-273-5550 | okun@neurology.ufl.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D014202 | Tremor |
| D009127 | Muscle Rigidity |
| D018476 | Hypokinesia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| DBS of the GPI | Procedure | Patients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device. |
|
| Change in Visual Analogue Mood Scales (VAMS) Energetic State | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Change in Visual Analogue Mood Scales (VAMS) Happy State | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Change in Visual Analogue Mood Scales (VAMS) Sad State | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Change in Visual Analogue Mood Scales (VAMS) Tense State | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Change in Visual Analogue Mood Scales (VAMS) Tired State | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Pre-surgery baseline to 6 months of DBS stimulation |
| Change in Beck Depression Inventory (BDI) | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
| Change in Letter Fluency Tasks (LFT) | 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. | Pre-surgery baseline to 6 months of DBS stimulation |
Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
| BG002 | Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) | Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A control group of PD patients that have not undergone surgical intervention (ie. DBS). |
| OG001 | Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) | Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD) |
| OG002 | Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) | Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD) |
|
|
| Secondary | Change in Spielberger State-Trait Anxiety Inventory (STAI) | 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. | Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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|
|
| Secondary | Change in Beck Depression Inventory (BDI) | 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. | Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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|
| Secondary | Change in Letter Fluency Tasks (LFT) | 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. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| Primary | Change in Visual Analogue Mood Scales (VAMS) Afraid State | 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. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| Primary | Change in Visual Analogue Mood Scales (VAMS) Confused State | 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. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| Primary | Change in Visual Analogue Mood Scales (VAMS) Energetic State | 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. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| Primary | Change in Visual Analogue Mood Scales (VAMS) Happy State | 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. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| Primary | Change in Visual Analogue Mood Scales (VAMS) Sad State | 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. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| Primary | Change in Visual Analogue Mood Scales (VAMS) Tense State | 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. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| Primary | Change in Visual Analogue Mood Scales (VAMS) Tired State | 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. | Posted | Mean | Standard Deviation | T-score | Pre-surgery baseline to 6 months of DBS stimulation |
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) | Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD) | 6 | 26 | 25 | 26 |
| EG002 | Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) | Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD) | 8 | 26 | 23 | 26 |
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | Non-systematic Assessment |
|
| Pneumonia Resulting in Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Symptomatic Hemorrhage | Nervous system disorders | Non-systematic Assessment |
|
| Symptomatic Venous Hemorrhage | Nervous system disorders | Non-systematic Assessment |
|
| Air Embolus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anxiety/Feafulness/Preocupation with Health | Psychiatric disorders | Non-systematic Assessment |
|
| Hemorrhage Resulting in Death | Nervous system disorders | Non-systematic Assessment |
|
| Anxiety/Fearfulness/Preoccupation with Health | Psychiatric disorders | Non-systematic Assessment |
|
| Difficulty with Speech and Language/Increased Speech | Nervous system disorders | Non-systematic Assessment |
|
| Confusion/Disorientation/Difficulty Concentrating/Distractibility | Psychiatric disorders | Non-systematic Assessment |
|
| Irritability/Disruptive of Aggressive Behavior | Psychiatric disorders | Non-systematic Assessment |
|
| Obsessive-Compulsive Tendencies | Psychiatric disorders | Non-systematic Assessment |
|
| Manic Tendencies | Psychiatric disorders | Non-systematic Assessment |
|
| Worsening of Memory | Nervous system disorders | Non-systematic Assessment |
|
| Sleep Disturbance/Vivid Dreaming/Increased Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue/Tired | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Worsening of Balance/Gait Disturbance/Freezing | Nervous system disorders | Non-systematic Assessment |
|
| Decreased Libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dizziness/Lightheadedness/Orthostasis | General disorders | Non-systematic Assessment |
|
| Weakness | General disorders | Non-systematic Assessment |
|
| Weight Loss | General disorders | Non-systematic Assessment |
|
| Headache/Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Difficulty with Urination/Urinary Urgency/Distended Bladder | Renal and urinary disorders | Non-systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anorexia | Psychiatric disorders | Non-systematic Assessment |
|
| Pain/Discomfort/Pruritus/Erythema at Sight of Incision | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Stomach Cramps/Constipation/Indegestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cold/Low-grade Fever | Infections and infestations | Non-systematic Assessment |
|
| Dry Mouth | General disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |