Trial Outcomes & Findings for Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease (NCT NCT00360009)

NCT ID: NCT00360009

Last Updated: 2012-10-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: Pre-surgery baseline to 6 months of DBS stimulation
• Results posted on: 2012-10-31

Participant Flow

Participant milestones

Measure	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)
Overall Study STARTED	10	26	26
Overall Study COMPLETED	10	22	23
Overall Study NOT COMPLETED	0	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	No Deep Brain Stimuation (DBS) Control Group n=10 Participants A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) n=26 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=26 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants	40 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	42 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	26 participants n=7 Participants	26 participants n=5 Participants	62 participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-surgery baseline to 6 months of DBS stimulation

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

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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State	—	5.3 T-score Standard Deviation 10.2	-0.1 T-score Standard Deviation 5.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Visual Analogue Mood Scales (VAMS) Afraid State	—	1.3 T-score Standard Deviation 16.9	-2.2 T-score Standard Deviation 13.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Visual Analogue Mood Scales (VAMS) Confused State	—	5.7 T-score Standard Deviation 15.4	1.3 T-score Standard Deviation 11.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Visual Analogue Mood Scales (VAMS) Energetic State	—	-1.4 T-score Standard Deviation 12.3	2.0 T-score Standard Deviation 18.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Visual Analogue Mood Scales (VAMS) Happy State	—	2.9 T-score Standard Deviation 17.2	5.0 T-score Standard Deviation 13.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Visual Analogue Mood Scales (VAMS) Sad State	—	-2.4 T-score Standard Deviation 17.8	-1.0 T-score Standard Deviation 13.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Visual Analogue Mood Scales (VAMS) Tense State	—	-2.0 T-score Standard Deviation 17.5	-8.5 T-score Standard Deviation 20.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Visual Analogue Mood Scales (VAMS) Tired State	—	-8.5 T-score Standard Deviation 12.0	-2.0 T-score Standard Deviation 13.5

SECONDARY outcome

Timeframe: Pre-surgery baseline to 6 months of DBS stimulation

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

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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Spielberger State-Trait Anxiety Inventory (STAI)	—	-3.3 T-score Standard Deviation 13.4	0.3 T-score Standard Deviation 13.6

SECONDARY outcome

Timeframe: Pre-surgery baseline to 6 months of DBS stimulation

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

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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Beck Depression Inventory (BDI)	—	-2.8 T-score Standard Deviation 6.3	-4.6 T-score Standard Deviation 5.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	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) n=22 Participants Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=23 Participants Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Change in Letter Fluency Tasks (LFT)	—	-5.6 T-score Standard Deviation 6.7	0.3 T-score Standard Deviation 10.7

Adverse Events

No Deep Brain Stimuation (DBS) Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)

Serious events: 6 serious events

Other events: 25 other events

Deaths: 0 deaths

Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)

Serious events: 8 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Deep Brain Stimuation (DBS) Control Group n=10 participants at risk A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) n=26 participants at risk Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=26 participants at risk Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Nervous system disorders Confusion/Disorientation/Difficulty Concentrating/Distractability	0.00% 0/10	11.5% 3/26 • Number of events 3	7.7% 2/26 • Number of events 2
Infections and infestations Infection	0.00% 0/10	3.8% 1/26 • Number of events 1	3.8% 1/26 • Number of events 1
Nervous system disorders Transient Ischemic Attack	0.00% 0/10	3.8% 1/26 • Number of events 1	3.8% 1/26 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia Resulting in Death	0.00% 0/10	3.8% 1/26 • Number of events 1	0.00% 0/26
Nervous system disorders Symptomatic Hemorrhage	0.00% 0/10	0.00% 0/26	3.8% 1/26 • Number of events 1
Nervous system disorders Symptomatic Venous Hemorrhage	0.00% 0/10	0.00% 0/26	7.7% 2/26 • Number of events 2
Respiratory, thoracic and mediastinal disorders Air Embolus	0.00% 0/10	0.00% 0/26	3.8% 1/26 • Number of events 1
Psychiatric disorders Anxiety/Feafulness/Preocupation with Health	0.00% 0/10	0.00% 0/26	3.8% 1/26 • Number of events 1
Nervous system disorders Hemorrhage Resulting in Death	0.00% 0/10	3.8% 1/26 • Number of events 1	0.00% 0/26

Other adverse events

Measure	No Deep Brain Stimuation (DBS) Control Group n=10 participants at risk A control group of PD patients that have not undergone surgical intervention (ie. DBS).	Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) n=26 participants at risk Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)	Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) n=26 participants at risk Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
Psychiatric disorders Depression/Tearful/Decreased Confidence/Loss of Motivation/Feelings of Guilt	0.00% 0/10	76.9% 20/26 • Number of events 20	26.9% 7/26 • Number of events 7
Psychiatric disorders Anxiety/Fearfulness/Preoccupation with Health	0.00% 0/10	53.8% 14/26 • Number of events 14	23.1% 6/26 • Number of events 6
Nervous system disorders Difficulty with Speech and Language/Increased Speech	0.00% 0/10	30.8% 8/26 • Number of events 8	38.5% 10/26 • Number of events 10
Psychiatric disorders Confusion/Disorientation/Difficulty Concentrating/Distractibility	0.00% 0/10	26.9% 7/26 • Number of events 7	15.4% 4/26 • Number of events 4
Psychiatric disorders Irritability/Disruptive of Aggressive Behavior	0.00% 0/10	38.5% 10/26 • Number of events 10	19.2% 5/26 • Number of events 5
Psychiatric disorders Obsessive-Compulsive Tendencies	0.00% 0/10	19.2% 5/26 • Number of events 5	7.7% 2/26 • Number of events 2
Psychiatric disorders Manic Tendencies	0.00% 0/10	19.2% 5/26 • Number of events 5	3.8% 1/26 • Number of events 1
Nervous system disorders Worsening of Memory	0.00% 0/10	7.7% 2/26 • Number of events 2	11.5% 3/26 • Number of events 3
Nervous system disorders Sleep Disturbance/Vivid Dreaming/Increased Somnolence	0.00% 0/10	53.8% 14/26 • Number of events 14	42.3% 11/26 • Number of events 11
General disorders Fatigue/Tired	0.00% 0/10	42.3% 11/26 • Number of events 11	11.5% 3/26 • Number of events 3
General disorders Pain	0.00% 0/10	34.6% 9/26 • Number of events 9	7.7% 2/26 • Number of events 2
Nervous system disorders Worsening of Balance/Gait Disturbance/Freezing	0.00% 0/10	23.1% 6/26 • Number of events 6	19.2% 5/26 • Number of events 5
Reproductive system and breast disorders Decreased Libido	0.00% 0/10	11.5% 3/26 • Number of events 3	19.2% 5/26 • Number of events 5
General disorders Dizziness/Lightheadedness/Orthostasis	0.00% 0/10	15.4% 4/26 • Number of events 4	7.7% 2/26 • Number of events 2
General disorders Weakness	0.00% 0/10	15.4% 4/26 • Number of events 4	3.8% 1/26 • Number of events 1
General disorders Weight Loss	0.00% 0/10	11.5% 3/26 • Number of events 3	7.7% 2/26 • Number of events 2
Nervous system disorders Headache/Migraine	0.00% 0/10	7.7% 2/26 • Number of events 2	11.5% 3/26 • Number of events 3
Renal and urinary disorders Difficulty with Urination/Urinary Urgency/Distended Bladder	0.00% 0/10	3.8% 1/26 • Number of events 1	11.5% 3/26 • Number of events 3
Gastrointestinal disorders Nausea/Vomiting	0.00% 0/10	11.5% 3/26 • Number of events 3	3.8% 1/26 • Number of events 1
Psychiatric disorders Anorexia	0.00% 0/10	3.8% 1/26 • Number of events 1	11.5% 3/26 • Number of events 3
Skin and subcutaneous tissue disorders Pain/Discomfort/Pruritus/Erythema at Sight of Incision	0.00% 0/10	11.5% 3/26 • Number of events 3	3.8% 1/26 • Number of events 1
Gastrointestinal disorders Stomach Cramps/Constipation/Indegestion	0.00% 0/10	7.7% 2/26 • Number of events 2	3.8% 1/26 • Number of events 1
Infections and infestations Cold/Low-grade Fever	0.00% 0/10	7.7% 2/26 • Number of events 2	3.8% 1/26 • Number of events 1
General disorders Dry Mouth	0.00% 0/10	7.7% 2/26 • Number of events 2	3.8% 1/26 • Number of events 1

Additional Information

Michael Okun, M.D.

University of Florida Department of Neurology

Phone: 352-273-5550

Email: okun@neurology.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place