Trial Outcomes & Findings for Vercise Implantable Stimulator for Treating Parkinson's Disease (NCT NCT01221948)
NCT ID: NCT01221948
Last Updated: 2025-02-05
Results Overview
Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
26 weeks post first lead implantation
Results posted on
2025-02-05
Participant Flow
Subjects recruited at 6 European centers for the study
Participant milestones
| Measure |
Deep Brain Stimulation
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Deep Brain Stimulation
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
not disclosed
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
4
|
Baseline Characteristics
Vercise Implantable Stimulator for Treating Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Deep Brain Stimulation
n=40 Participants
Vercise (TM) Rechargeable Deep Brain Stimulation System
Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System
|
|---|---|
|
Age, Customized
<=60 years
|
19 participants
n=5 Participants
|
|
Age, Customized
61-70 years
|
18 participants
n=5 Participants
|
|
Age, Customized
>70 years
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeks post first lead implantationUnified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.
Outcome measures
| Measure |
Deep Brain Stimulation
n=40 Participants
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).
|
-23.8 units on a scale
Standard Deviation 10.59
|
SECONDARY outcome
Timeframe: 12 and 52 weeks post first lead implantationUnified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results.
Outcome measures
| Measure |
Deep Brain Stimulation
n=40 Participants
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
Mean Change from Baseline to Week 12
|
-22.3 units on a scale
Standard Deviation 8.05
|
|
Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
Mean Change from Baseline to Week 52
|
-23.7 units on a scale
Standard Deviation 8.83
|
SECONDARY outcome
Timeframe: 12, 26 and 52 weeks post first lead implantationUnified Parkinson's Disease Rating Scale Part II (UPDRS II) is a sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate Activities of Daily Living. This section contains 13 items. Each item is scored on a scale from 0 (normal) to 4 (disabled), with the total score for the 13 items ranging from 0 to 52.
Outcome measures
| Measure |
Deep Brain Stimulation
n=40 Participants
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
Change from Baseline to 12 weeks
|
-10.5 units on a scale
Standard Deviation 7.76
|
|
Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
Change from Baseline to 26 weeks
|
-11.8 units on a scale
Standard Deviation 5.96
|
|
Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.
Change from Baseline to 52 weeks
|
-10.1 units on a scale
Standard Deviation 8.55
|
SECONDARY outcome
Timeframe: 12, 26 and 52 weeks post first lead implantationPopulation: 40 completed Baseline, 35 completed Week12, 39 completed Week 26 and 38 completed Week 52
All parkinsonian medications will be converted to Levodopa dose equivalents (LED) and baseline dose will be compared with dose taken at 12, 26 and 52 weeks post implantation
Outcome measures
| Measure |
Deep Brain Stimulation
n=40 Participants
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
Change from Baseline to 12 weeks
|
-683.126 mg
Standard Deviation 537.91
|
|
Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
Change from Baseline to 26 Weeks
|
-740 mg
Standard Deviation 603.6
|
|
Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation
Change from Baseline to 52 weeks
|
-816 mg
Standard Deviation 571.4
|
SECONDARY outcome
Timeframe: 12, 26 and 52 weeks post first lead implantationSubjects will complete a 3-day motor diary prior to study visits. At one-hour increments (during waking hours), patients will record "on", "on with troublesome dyskinesia", "off", and "asleep" times for three consecutive days.
Outcome measures
| Measure |
Deep Brain Stimulation
n=40 Participants
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.
Change from Baseline to 12 weeks in ON time
|
3.1 hours/day
Standard Deviation 7.3
|
|
Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.
Change from Baseline to 26 weeks in ON time
|
3 hours/day
Standard Deviation 6.31
|
|
Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.
Change from Baseline to 52 weeks in ON time
|
3.5 hours/day
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: 12, 26 and 52 weeks post first lead implantationThe Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. The questions measure the impact on health-related quality of life along 8 dimensions: * mobility * activities of daily living * emotional well-being * stigma * social support * cognitions * communication * bodily discomfort. Dimension scores range from 0 to 100, with 0 representing perfect health for the measure and 100 representing worst health for the measure.
Outcome measures
| Measure |
Deep Brain Stimulation
n=40 Participants
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Mean Percent Change in Quality of Life Scale Scores: Parkinson's Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.
Percent Change from Baseline to 12 Weeks
|
-38 percentage change
Standard Deviation 41.2
|
|
Mean Percent Change in Quality of Life Scale Scores: Parkinson's Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.
Percent Change from Baseline to 26 Weeks
|
-29 percentage change
Standard Deviation 39
|
|
Mean Percent Change in Quality of Life Scale Scores: Parkinson's Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.
Percent Change from Baseline to 52 Weeks
|
-34.5 percentage change
Standard Deviation 45.6
|
SECONDARY outcome
Timeframe: 12, 26 and 52 weeks post first lead implantationThe purpose of the Schwab and England (SE) (13) single-item scale is to quantify a PD patients' ability to perform activities of daily living. The single item is based on a percentage rating with scores in 10% increments. Scores range from 0% (completely bed-ridden) to 100% (completely independent).
Outcome measures
| Measure |
Deep Brain Stimulation
n=40 Participants
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on
Percent Change from baseline to 12 weeks
|
9 percentage change
Standard Deviation 21
|
|
Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on
Percent Change from baseline to 26 weeks
|
12 percentage change
Standard Deviation 26.2
|
|
Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on
Percent Change from Baseline to 52 weeks
|
12.5 percentage change
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 52 weeks post first lead implantationGlobal Impression of Change (GIC) is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: ("very much improved" to "marked worsening"). This assessment was completed by the neurologist.
Outcome measures
| Measure |
Deep Brain Stimulation
n=40 Participants
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.
Percent Improved at 52 weeks
|
97.4 percentage of participants
|
|
Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.
Percent with no change at 52 weeks
|
0 percentage of participants
|
|
Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.
Percent worsened at 52 weeks
|
2.6 percentage of participants
|
Adverse Events
Deep Brain Stimulation
Serious events: 10 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deep Brain Stimulation
n=40 participants at risk
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Infections and infestations
Influenza
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Cystitis
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Helicobacter gastritis
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Implant site infection
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Localised infection
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device migration
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Akinesia
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Parkinson's disease
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Deep Brain Stimulation
n=40 participants at risk
All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
2.5%
1/40 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
22.5%
9/40 • Number of events 10
|
|
Injury, poisoning and procedural complications
Hand fracture
|
7.5%
3/40 • Number of events 3
|
|
Injury, poisoning and procedural complications
Head injury
|
5.0%
2/40 • Number of events 2
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
5.0%
2/40 • Number of events 2
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.5%
1/40 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Restless legs syndrome
|
7.5%
3/40 • Number of events 3
|
|
Nervous system disorders
Dystonia
|
5.0%
2/40 • Number of events 3
|
|
Nervous system disorders
Paraesthesia
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Parkinson's disease
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Tremor
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Cerebral microangiopathy
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Movement disorder
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Nerve root lesion
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Depression
|
15.0%
6/40 • Number of events 6
|
|
Psychiatric disorders
Apathy
|
7.5%
3/40 • Number of events 3
|
|
Psychiatric disorders
Anger
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Hallucination, auditory
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Impulse-control disorder
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Rapid eye movements sleep abnormal
|
2.5%
1/40 • Number of events 1
|
|
Reproductive system and breast disorders
Urinary tract infection
|
5.0%
2/40 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Ear infection
|
2.5%
1/40 • Number of events 2
|
|
Infections and infestations
Incision site infection
|
2.5%
1/40 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Gait disturbance
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Adverse drug reaction
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Axillary pain
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Cyst
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Drug withdrawal syndrome
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Implant site haematoma
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.5%
1/40 • Number of events 1
|
|
Metabolism and nutrition disorders
Folate deficiency
|
2.5%
1/40 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis
|
2.5%
1/40 • Number of events 1
|
|
Eye disorders
Diplopia
|
2.5%
1/40 • Number of events 1
|
|
Eye disorders
Macular degeneration
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
2.5%
1/40 • Number of events 1
|
|
Investigations
Weight increased
|
2.5%
1/40 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • Number of events 1
|
Additional Information
Nic Van Dyck, Director International Clinical Operations
Bostons Scientific Neuromodulation
Phone: +31 43 3568328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place