Trial Outcomes & Findings for Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD) (NCT NCT00282152)
NCT ID: NCT00282152
Last Updated: 2017-05-30
Results Overview
The primary hypothesis of this feasibility trial was focused on safety and tolerability and that the DBS+ODT group would not worsen more quickly than the ODT group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
baseline to 24 months
Results posted on
2017-05-30
Participant Flow
7 participants excluded prior to treatment ( 1 withdrew consent and 6 failed screening)
Participant milestones
| Measure |
Optimal Drug Therapy (ODT)
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Optimal Drug Therapy (ODT)
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Baseline characteristics by cohort
| Measure |
Optimal Drug Therapy (ODT)
n=15 Participants
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 Participants
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 24 monthsPopulation: all 29 subjects that completed at least one follow up visit were included in the primary analysis following intent to treat principle
The primary hypothesis of this feasibility trial was focused on safety and tolerability and that the DBS+ODT group would not worsen more quickly than the ODT group.
Outcome measures
| Measure |
Optimal Drug Therapy (ODT)
n=14 Participants
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 Participants
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
|
|---|---|---|
|
Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
|
15 months
Interval 10.7 to 19.3
|
14.1 months
Interval 10.3 to 18.0
|
PRIMARY outcome
Timeframe: baseline to 24 months100 mg of levodopa with a dopa-decarboxylase inhibitor = 133 mg of controlled-release levodopa preparations = total levodopa dose + (total levodopa dose x 0.33) of levodopa with dopa-decarboxylase and entacapone = 1 mg of pergolide, pramipexole, or lisuride = 5 mg of ropinirole = 3.3 mg of rotigotine
Outcome measures
| Measure |
Optimal Drug Therapy (ODT)
n=14 Participants
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 Participants
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
|
|---|---|---|
|
Levodopa Equivalents, Change From Baseline
|
214.5 mg
Interval 16.9 to 412.1
|
97.7 mg
Interval -93.7 to 288.7
|
SECONDARY outcome
Timeframe: baseline to 24 monthsScore: 0-16 0 =normal, 16 = most disability
Outcome measures
| Measure |
Optimal Drug Therapy (ODT)
n=14 Participants
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 Participants
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
|
|---|---|---|
|
Change in UPDRS Part I, Mentation Behavior and Mood
|
1.1 units on a scale
Interval -0.1 to 2.3
|
1.2 units on a scale
Interval 0.1 to 2.3
|
SECONDARY outcome
Timeframe: baseline to 24 monthsScore: 0-52 0 =normal, 52 = most limited
Outcome measures
| Measure |
Optimal Drug Therapy (ODT)
n=14 Participants
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 Participants
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
|
|---|---|---|
|
Change in UPDRS Part II, Activities of Daily Living
|
2.3 units on a scale
Interval -1.2 to 5.8
|
4.1 units on a scale
Interval 0.7 to 7.5
|
SECONDARY outcome
Timeframe: baseline to 24 monthsScore: 0-56 0 = full movement, 56 = most limited
Outcome measures
| Measure |
Optimal Drug Therapy (ODT)
n=14 Participants
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 Participants
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
|
|---|---|---|
|
Change in UPDRS Part III, Motor Examination, Excluding Rigidity
|
3.4 change in units on a scale
Interval -2.9 to 9.8
|
0.1 change in units on a scale
Interval -6.0 to 6.1
|
SECONDARY outcome
Timeframe: baseline to 24 monthsScore: 0-23 0 =no complications, 23 = most complications
Outcome measures
| Measure |
Optimal Drug Therapy (ODT)
n=14 Participants
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 Participants
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
|
|---|---|---|
|
Change in UPDRS Part IV, Complications of Therapy
|
1.9 units on a scale
Interval 0.4 to 3.4
|
0.3 units on a scale
Interval -1.2 to 1.7
|
SECONDARY outcome
Timeframe: baseline to 24 monthsThe Total Unified Parkinson's Disease Rating Scale (UPDRS) is a composite scale, consisting of four sections that evaluate mood and behavior, activities of daily living, motor symptoms, and complications of medical therapy. Range is 0 to 16, with 16 being maximal disability
Outcome measures
| Measure |
Optimal Drug Therapy (ODT)
n=14 Participants
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 Participants
Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson's disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary.
|
|---|---|---|
|
Change in Total UPDRS
|
8.4 units on a scale
Interval -0.3 to 17.0
|
5.63 units on a scale
Interval -2.6 to 13.9
|
Adverse Events
Optimal Drug Therapy (ODT)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Optimal Drug Therapy (ODT)
n=15 participants at risk；n=14 participants at risk
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 participants at risk
Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs
|
|---|---|---|
|
Nervous system disorders
Perioperative infarction in left basil ganglia
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Infections and infestations
Infection
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
Other adverse events
| Measure |
Optimal Drug Therapy (ODT)
n=15 participants at risk；n=14 participants at risk
Patients receive optimal drug therapy as prescribed by their treating neurologist.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.
|
Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
n=15 participants at risk
Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.
B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.
Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs
|
|---|---|---|
|
Nervous system disorders
Insomnia
|
35.7%
5/14 • Number of events 7 • baseline to 24 months
|
53.3%
8/15 • Number of events 8 • baseline to 24 months
|
|
Gastrointestinal disorders
Nausea
|
42.9%
6/14 • Number of events 10 • baseline to 24 months
|
20.0%
3/15 • Number of events 3 • baseline to 24 months
|
|
Immune system disorders
Nasopharyngitis
|
14.3%
2/14 • Number of events 3 • baseline to 24 months
|
33.3%
5/15 • Number of events 7 • baseline to 24 months
|
|
General disorders
Weight decreased
|
42.9%
6/14 • Number of events 6 • baseline to 24 months
|
20.0%
3/15 • Number of events 3 • baseline to 24 months
|
|
Nervous system disorders
Dizziness
|
35.7%
5/14 • Number of events 7 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.4%
3/14 • Number of events 3 • baseline to 24 months
|
26.7%
4/15 • Number of events 5 • baseline to 24 months
|
|
General disorders
Weight increased
|
35.7%
5/14 • Number of events 5 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • Number of events 4 • baseline to 24 months
|
6.7%
1/15 • Number of events 3 • baseline to 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
21.4%
3/14 • Number of events 3 • baseline to 24 months
|
20.0%
3/15 • Number of events 3 • baseline to 24 months
|
|
General disorders
Fatigue
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
20.0%
3/15 • Number of events 4 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
28.6%
4/14 • Number of events 4 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 2 • baseline to 24 months
|
6.7%
1/15 • Number of events 3 • baseline to 24 months
|
|
Gastrointestinal disorders
Constipation
|
21.4%
3/14 • Number of events 3 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
Nervous system disorders
Memory impairment
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
20.0%
3/15 • Number of events 3 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
13.3%
2/15 • Number of events 3 • baseline to 24 months
|
|
Cardiac disorders
Chest pain
|
21.4%
3/14 • Number of events 3 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Number of events 3 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Infections and infestations
Urinary tract infection
|
21.4%
3/14 • Number of events 3 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Hallucination
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Pain in extremity
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Somnolence
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Presyncope
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 2 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
General disorders
Decreased appetite
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • baseline to 24 months
|
20.0%
3/15 • Number of events 3 • baseline to 24 months
|
|
Nervous system disorders
Abnormal touch sensation
|
0.00%
0/14 • baseline to 24 months
|
20.0%
3/15 • Number of events 3 • baseline to 24 months
|
|
Surgical and medical procedures
Implant site pain
|
0.00%
0/14 • baseline to 24 months
|
20.0%
3/15 • Number of events 3 • baseline to 24 months
|
|
Nervous system disorders
Aphasia
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Eye disorders
Diplopia
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Renal and urinary disorders
Haematuria
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
General disorders
Hot flush
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Nervous system disorders
Vision blurred
|
14.3%
2/14 • Number of events 2 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Number of events 2 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Nervous system disorders
Agitation
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Surgical and medical procedures
Incision site pain
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 2 • baseline to 24 months
|
|
Nervous system disorders
Confusional state
|
0.00%
0/14 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/14 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
General disorders
Restlessness
|
0.00%
0/14 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/14 • baseline to 24 months
|
13.3%
2/15 • Number of events 2 • baseline to 24 months
|
|
Nervous system disorders
Abnormal dreams
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Immune system disorders
Allergic rhinitis
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Nervous system disorders
Asthenia
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Cardiac disorders
Blood pressure fluctuation
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Nervous system disorders
Cognitive disorder
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Cardiac disorders
Coronary artery disease
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
General disorders
Dysphonia
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Gastrointestinal disorders
Gastric ulcers
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Renal and urinary disorders
Hydronephrosis
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Nervous system disorders
Hypersensitivity
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Cardiac disorders
Hypotension
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
General disorders
Increased appetite
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Infections and infestations
Influenza like illness
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Inguinal hernia
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Renal and urinary disorders
Kidney enlargement
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Reproductive system and breast disorders
Libido decreased
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
General disorders
Peripheral oedema
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
General disorders
Toothache
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Cardiac disorders
Troponin increased
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Renal and urinary disorders
Urine output decreased
|
7.1%
1/14 • Number of events 1 • baseline to 24 months
|
0.00%
0/15 • baseline to 24 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Decreased interest
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Drooling
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Gastrointestinal disorders
Early satiety
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Hallucination, auditory
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Gastrointestinal disorders
Hepatic steatosis
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Hyperhidrosis
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Surgical and medical procedures
Infection - Other (DBS lead)
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Mood altered
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
General disorders
Muscular weakness
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Neurophathy peripheral
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Nightmare
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Pseudomeningocele
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Infections and infestations
Pyrexia
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Immune system disorders
Rhinitis allergic
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Sensation of heaviness
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Immune system disorders
Sinus congestion
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
|
Nervous system disorders
Vertigo
|
0.00%
0/14 • baseline to 24 months
|
6.7%
1/15 • Number of events 1 • baseline to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place