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Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00282152
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
David Charles, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Parkinson's Disease
Interventions Device: B-STN DBS
Drug: Optimal drug therapy
Enrollment 37
Recruitment Details  
Pre-assignment Details 7 participants excluded prior to treatment ( 1 withdrew consent and 6 failed screening)
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 15 15
Completed 14 15
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
60
(51 to 69)
60
(52 to 74)
60
(51 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
2
  13.3%
1
   6.7%
3
  10.0%
Male
13
  86.7%
14
  93.3%
27
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Safety: Time to Reach a 4 Point Increase (Worsening) in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score
Hide Description 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.
Time Frame baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
all 29 subjects that completed at least one follow up visit were included in the primary analysis following intent to treat principle
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 14 15
Mean (95% Confidence Interval)
Unit of Measure: months
15
(10.7 to 19.3)
14.1
(10.3 to 18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Optimal Drug Therapy (ODT), Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Because the purpose of this trial was to provide preliminary safety and tolerability data, the primary hypothesis was that the DBS+ODT group would not worsen more quickly than the ODT group. The primary endpoint was defined as the time to reach a four-point worsening of the UPDRS-III score following a one week treatment washout as assessed by the blinded rater.
Statistical Test of Hypothesis P-Value 0.968
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title Levodopa Equivalents, Change From Baseline
Hide Description 100 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
Time Frame baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 14 15
Mean (95% Confidence Interval)
Unit of Measure: mg
214.5
(16.9 to 412.1)
97.7
(-93.7 to 288.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Optimal Drug Therapy (ODT), Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Comments Study power was calculated based on the amount of PD medication consumed. We anticipated that the control group (ODT) would have a baseline value of 400 which would increase to 600, and that the treated group (DBS+ODT) would decrease from 400 to 300. A sample size of 12 patients per group (n=15, assuming 20% drop out) would have 80% power to detect a difference in means of 300 assuming that the common standard deviation is 250 using a two group t-test with a 0.05 two-sided significance level.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in UPDRS Part I, Mentation Behavior and Mood
Hide Description Score: 0-16 0 =normal, 16 = most disability
Time Frame baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 14 15
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.1
(-0.1 to 2.3)
1.2
(0.1 to 2.3)
4.Secondary Outcome
Title Change in UPDRS Part II, Activities of Daily Living
Hide Description Score: 0-52 0 =normal, 52 = most limited
Time Frame baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 14 15
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.3
(-1.2 to 5.8)
4.1
(0.7 to 7.5)
5.Secondary Outcome
Title Change in UPDRS Part III, Motor Examination, Excluding Rigidity
Hide Description Score: 0-56 0 = full movement, 56 = most limited
Time Frame baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 14 15
Mean (95% Confidence Interval)
Unit of Measure: change in units on a scale
3.4
(-2.9 to 9.8)
0.1
(-6 to 6.1)
6.Secondary Outcome
Title Change in UPDRS Part IV, Complications of Therapy
Hide Description Score: 0-23 0 =no complications, 23 = most complications
Time Frame baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 14 15
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.9
(0.4 to 3.4)
0.3
(-1.2 to 1.7)
7.Secondary Outcome
Title Change in Total UPDRS
Hide Description

The 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

Time Frame baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 14 15
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
8.4
(-0.3 to 17)
5.63
(-2.6 to 13.9)
Time Frame baseline to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Hide Arm/Group Description

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.

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

All-Cause Mortality
Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      2/15 (13.33%)    
Infections and infestations     
Infection  [1]  0/14 (0.00%)  0 1/15 (6.67%)  1
Nervous system disorders     
Perioperative infarction in left basil ganglia   0/14 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
Developed due to injury at subject's home.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Optimal Drug Therapy (ODT) Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      15/15 (100.00%)    
Blood and lymphatic system disorders     
Pernicious anaemia   0/14 (0.00%)  0 1/15 (6.67%)  1
Cardiac disorders     
Chest pain   3/14 (21.43%)  3 0/15 (0.00%)  0
Blood pressure fluctuation   1/14 (7.14%)  1 0/15 (0.00%)  0
Coronary artery disease   1/14 (7.14%)  1 0/15 (0.00%)  0
Hypotension   1/14 (7.14%)  1 0/15 (0.00%)  0
Troponin increased   1/14 (7.14%)  1 0/15 (0.00%)  0
Ear and labyrinth disorders     
Deafness   0/14 (0.00%)  0 1/15 (6.67%)  1
Endocrine disorders     
Hypothyroidism   1/14 (7.14%)  1 0/15 (0.00%)  0
Eye disorders     
Diplopia   2/14 (14.29%)  2 0/15 (0.00%)  0
Gastrointestinal disorders     
Nausea   6/14 (42.86%)  10 3/15 (20.00%)  3
Vomiting   4/14 (28.57%)  4 1/15 (6.67%)  3
Dysphagia   3/14 (21.43%)  3 3/15 (20.00%)  3
Constipation   3/14 (21.43%)  3 1/15 (6.67%)  1
Diarrhoea   3/14 (21.43%)  3 0/15 (0.00%)  0
Oropharyngeal pain   1/14 (7.14%)  2 0/15 (0.00%)  0
Hiatus hernia   1/14 (7.14%)  1 1/15 (6.67%)  1
Abdominal distension   0/14 (0.00%)  0 1/15 (6.67%)  2
Gastric ulcers   1/14 (7.14%)  1 0/15 (0.00%)  0
Gastrointestinal oedema   1/14 (7.14%)  1 0/15 (0.00%)  0
Dyspepsia   0/14 (0.00%)  0 1/15 (6.67%)  1
Early satiety   0/14 (0.00%)  0 1/15 (6.67%)  1
Gastroenteritis viral   0/14 (0.00%)  0 1/15 (6.67%)  1
Haematochezia   0/14 (0.00%)  0 1/15 (6.67%)  1
Hepatic steatosis   0/14 (0.00%)  0 1/15 (6.67%)  1
General disorders     
Weight decreased   6/14 (42.86%)  6 3/15 (20.00%)  3
Weight increased   5/14 (35.71%)  5 2/15 (13.33%)  2
Fatigue   2/14 (14.29%)  2 3/15 (20.00%)  4
Decreased appetite   1/14 (7.14%)  1 2/15 (13.33%)  2
Hot flush   2/14 (14.29%)  2 0/15 (0.00%)  0
Pain   1/14 (7.14%)  1 1/15 (6.67%)  1
Restlessness   0/14 (0.00%)  0 2/15 (13.33%)  2
Dysphonia   1/14 (7.14%)  1 0/15 (0.00%)  0
Increased appetite   1/14 (7.14%)  1 0/15 (0.00%)  0
Peripheral oedema   1/14 (7.14%)  1 0/15 (0.00%)  0
Toothache   1/14 (7.14%)  1 0/15 (0.00%)  0
Muscular weakness   0/14 (0.00%)  0 1/15 (6.67%)  1
Hepatobiliary disorders     
Hepatic cirrhosis   1/14 (7.14%)  1 0/15 (0.00%)  0
Immune system disorders     
Nasopharyngitis   2/14 (14.29%)  3 5/15 (33.33%)  7
Allergic rhinitis   1/14 (7.14%)  1 0/15 (0.00%)  0
Rhinitis allergic   0/14 (0.00%)  0 1/15 (6.67%)  1
Sinus congestion   0/14 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations     
Urinary tract infection   3/14 (21.43%)  3 0/15 (0.00%)  0
Influenza   0/14 (0.00%)  0 2/15 (13.33%)  2
Influenza like illness   1/14 (7.14%)  1 0/15 (0.00%)  0
Eye infection   0/14 (0.00%)  0 1/15 (6.67%)  1
Pyrexia   0/14 (0.00%)  0 1/15 (6.67%)  1
Sinusitis   0/14 (0.00%)  0 1/15 (6.67%)  1
Injury, poisoning and procedural complications     
Rib fracture   1/14 (7.14%)  1 1/15 (6.67%)  1
Excoriation   1/14 (7.14%)  1 0/15 (0.00%)  0
Incision site erythema   1/14 (7.14%)  1 0/15 (0.00%)  0
Limb injury   1/14 (7.14%)  1 0/15 (0.00%)  0
Contusion   0/14 (0.00%)  0 1/15 (6.67%)  1
Hand fracture   0/14 (0.00%)  0 1/15 (6.67%)  1
Laceration   0/14 (0.00%)  0 1/15 (6.67%)  1
Thermal burn   0/14 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Neck pain   4/14 (28.57%)  4 1/15 (6.67%)  1
Musculoskeletal pain   1/14 (7.14%)  1 2/15 (13.33%)  3
Back pain   2/14 (14.29%)  2 1/15 (6.67%)  1
Arthralgia   1/14 (7.14%)  1 2/15 (13.33%)  2
Joint swelling   1/14 (7.14%)  1 1/15 (6.67%)  1
Myalgia   0/14 (0.00%)  0 2/15 (13.33%)  2
Carpal tunnel syndrome   1/14 (7.14%)  1 0/15 (0.00%)  0
Inguinal hernia   1/14 (7.14%)  1 0/15 (0.00%)  0
Musculoskeletal stiffness   1/14 (7.14%)  1 0/15 (0.00%)  0
Osteoarthritis   1/14 (7.14%)  1 0/15 (0.00%)  0
Joint range of motion decreased   0/14 (0.00%)  0 1/15 (6.67%)  1
Muscle tightness   0/14 (0.00%)  0 1/15 (6.67%)  1
Spinal osteoarthritis   0/14 (0.00%)  0 1/15 (6.67%)  1
Spondylolisthesis   0/14 (0.00%)  0 1/15 (6.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer   1/14 (7.14%)  1 0/15 (0.00%)  0
Thyroid cancer   1/14 (7.14%)  1 0/15 (0.00%)  0
Nervous system disorders     
Insomnia   5/14 (35.71%)  7 8/15 (53.33%)  8
Dizziness   5/14 (35.71%)  7 1/15 (6.67%)  1
Headache   1/14 (7.14%)  2 1/15 (6.67%)  3
Memory impairment   1/14 (7.14%)  1 3/15 (20.00%)  3
Hallucination   2/14 (14.29%)  2 1/15 (6.67%)  1
Pain in extremity   2/14 (14.29%)  2 1/15 (6.67%)  1
Somnolence   2/14 (14.29%)  2 1/15 (6.67%)  1
Presyncope   1/14 (7.14%)  1 1/15 (6.67%)  2
Abnormal touch sensation   0/14 (0.00%)  0 3/15 (20.00%)  3
Aphasia   2/14 (14.29%)  2 0/15 (0.00%)  0
Vision blurred   2/14 (14.29%)  2 0/15 (0.00%)  0
Agitation   1/14 (7.14%)  1 1/15 (6.67%)  1
Confusional state   0/14 (0.00%)  0 2/15 (13.33%)  2
Abnormal dreams   1/14 (7.14%)  1 0/15 (0.00%)  0
Asthenia   1/14 (7.14%)  1 0/15 (0.00%)  0
Cognitive disorder   1/14 (7.14%)  1 0/15 (0.00%)  0
Hypersensitivity   1/14 (7.14%)  1 0/15 (0.00%)  0
Hypoaesthesia   1/14 (7.14%)  1 0/15 (0.00%)  0
Syncope   1/14 (7.14%)  1 0/15 (0.00%)  0
Decreased interest   0/14 (0.00%)  0 1/15 (6.67%)  1
Drooling   0/14 (0.00%)  0 1/15 (6.67%)  1
Hallucination, auditory   0/14 (0.00%)  0 1/15 (6.67%)  1
Hyperhidrosis   0/14 (0.00%)  0 1/15 (6.67%)  1
Mood altered   0/14 (0.00%)  0 1/15 (6.67%)  1
Neurophathy peripheral   0/14 (0.00%)  0 1/15 (6.67%)  1
Nightmare   0/14 (0.00%)  0 1/15 (6.67%)  1
Pseudomeningocele   0/14 (0.00%)  0 1/15 (6.67%)  1
Psychomotor hyperactivity   0/14 (0.00%)  0 1/15 (6.67%)  1
Restless legs syndrome   0/14 (0.00%)  0 1/15 (6.67%)  1
Sensation of heaviness   0/14 (0.00%)  0 1/15 (6.67%)  1
Vertigo   0/14 (0.00%)  0 1/15 (6.67%)  1
Psychiatric disorders     
Depression   0/14 (0.00%)  0 3/15 (20.00%)  3
Anxiety   0/14 (0.00%)  0 1/15 (6.67%)  1
Renal and urinary disorders     
Haematuria   2/14 (14.29%)  2 0/15 (0.00%)  0
Nephrolithiasis   1/14 (7.14%)  1 1/15 (6.67%)  1
Micturition urgency   0/14 (0.00%)  0 2/15 (13.33%)  2
Hydronephrosis   1/14 (7.14%)  1 0/15 (0.00%)  0
Kidney enlargement   1/14 (7.14%)  1 0/15 (0.00%)  0
Pollakiuria   1/14 (7.14%)  1 0/15 (0.00%)  0
Urine output decreased   1/14 (7.14%)  1 0/15 (0.00%)  0
Dysuria   0/14 (0.00%)  0 1/15 (6.67%)  1
Urinary incontinence   0/14 (0.00%)  0 1/15 (6.67%)  1
Reproductive system and breast disorders     
Erectile dysfunction   2/14 (14.29%)  2 0/15 (0.00%)  0
Libido decreased   1/14 (7.14%)  1 0/15 (0.00%)  0
Testicular pain   0/14 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   3/14 (21.43%)  3 4/15 (26.67%)  5
Bronchitis   2/14 (14.29%)  2 2/15 (13.33%)  2
Upper-airway cough syndrome   2/14 (14.29%)  2 0/15 (0.00%)  0
Cough   1/14 (7.14%)  1 1/15 (6.67%)  1
Sleep apnoea syndrome   0/14 (0.00%)  0 2/15 (13.33%)  2
Pneumonia   1/14 (7.14%)  1 0/15 (0.00%)  0
Tracheobronchitis   0/14 (0.00%)  0 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Plantar erythema   1/14 (7.14%)  1 0/15 (0.00%)  0
Rash papular   1/14 (7.14%)  1 0/15 (0.00%)  0
Surgical and medical procedures     
Implant site pain   0/14 (0.00%)  0 3/15 (20.00%)  3
Incision site pain   1/14 (7.14%)  1 1/15 (6.67%)  1
Infection - Other (DBS lead)   0/14 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: David Charles, MD
Organization: Vanderbilt University Medical Center
EMail: david.charles@Vanderbilt.Edu
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Responsible Party: David Charles, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00282152    
Other Study ID Numbers: 040797
1363 ( Other Identifier: Clinical Research Center )
G050016 ( Other Identifier: FDA IDE )
First Submitted: January 23, 2006
First Posted: January 25, 2006
Results First Submitted: April 19, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017