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The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
This is a multi-center, prospective, open label, non-randomized study which will use a within-patient control (each patient serves as his/her own control) to document patient outcomes, including effectiveness, safety, and health economic data for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation | Experimental | Rechargeable Deep Brain Stimulation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Rechargeable Deep Brain Stimulation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 26 weeks post first lead implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Timmermann, M.D. | Universitätsklinikum Köln | Principal Investigator |
| François Alesch, M.D. | Allgemeines Krankenhaus AKH, Vienna, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus AKH | Vienna | Austria | ||||
| CHU de Rennes-Pontchaillou |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26027940 | Derived | Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brucke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Verin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28. |
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Subjects recruited at 6 European centers for the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Brain Stimulation | All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
40 enrolled subjects who met study eligibility were implanted with the Vercise DBS system.
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Brain Stimulation | Vercise (TM) Rechargeable Deep Brain Stimulation System Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 and 52 weeks post first lead implantation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deep Brain Stimulation | All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nic Van Dyck, Director International Clinical Operations | Bostons Scientific Neuromodulation | +31 43 3568328 | vandyckn@bsci.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Boston Scientific Vercise Deep Brain Stimulation system will be implanted and each patient will serve as its own control.
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| 12 and 52 weeks post first lead implantation |
| Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Unified 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. | 12, 26 and 52 weeks post first lead implantation |
| Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation | 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 | 12, 26 and 52 weeks post first lead implantation |
| 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. | Subjects 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. | 12, 26 and 52 weeks post first lead implantation |
| 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. | The 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:
| 12, 26 and 52 weeks post first lead implantation |
| 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 | The 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). | 12, 26 and 52 weeks post first lead implantation |
| Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist. | Global 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. | 52 weeks post first lead implantation |
| Rennes |
| France |
| Uniklinik Köln | Cologne | Germany |
| IRCCS Istituto Ortopedico Galeazzi | Milan | Italy |
| Hospital Central de Asturias | Oviedo | Spain |
| Frenchay Hospital | Bristol | United Kingdom |
| Southmead Hospital Bristol | Bristol | United Kingdom |
| Death |
|
| Protocol Violation |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off. | Unified 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. | Posted | Mean | Standard Deviation | units on a scale | 12, 26 and 52 weeks post first lead implantation |
|
|
|
| Secondary | Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation | 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 | 40 completed Baseline, 35 completed Week12, 39 completed Week 26 and 38 completed Week 52 | Posted | Mean | Standard Deviation | mg | 12, 26 and 52 weeks post first lead implantation |
|
|
|
| Secondary | 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. | Subjects 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. | Posted | Mean | Standard Deviation | hours/day | 12, 26 and 52 weeks post first lead implantation |
|
|
|
| Secondary | 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. | The 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:
| Posted | Mean | Standard Deviation | percentage change | 12, 26 and 52 weeks post first lead implantation |
|
|
|
| Secondary | 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 | The 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). | Posted | Mean | Standard Deviation | percentage change | 12, 26 and 52 weeks post first lead implantation |
|
|
|
| Primary | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks post first lead implantation |
|
|
|
| Secondary | Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist. | Global 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. | Posted | Number | percentage of participants | 52 weeks post first lead implantation |
|
|
|
| 10 |
| 40 |
| 37 |
| 40 |
| Cystitis | Infections and infestations |
|
| Helicobacter gastritis | Infections and infestations |
|
| Implant site infection | Infections and infestations |
|
| Localised infection | Infections and infestations |
|
| Pneumonia | Infections and infestations |
|
| Staphylococcal infection | Infections and infestations |
|
| Device migration | Injury, poisoning and procedural complications |
|
| Fall | Injury, poisoning and procedural complications |
|
| Joint sprain | Injury, poisoning and procedural complications |
|
| Skin laceration | Injury, poisoning and procedural complications |
|
| Akinesia | Nervous system disorders |
|
| Parkinson's disease | Nervous system disorders |
|
| Syncope | Nervous system disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders |
|
| Hand fracture | Injury, poisoning and procedural complications |
|
| Head injury | Injury, poisoning and procedural complications |
|
| Joint sprain | Injury, poisoning and procedural complications |
|
| Skeletal injury | Injury, poisoning and procedural complications |
|
| Alcohol poisoning | Injury, poisoning and procedural complications |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Fibula fracture | Injury, poisoning and procedural complications |
|
| Rib fracture | Injury, poisoning and procedural complications |
|
| Thermal burn | Injury, poisoning and procedural complications |
|
| Restless legs syndrome | Nervous system disorders |
|
| Dystonia | Nervous system disorders |
|
| Paraesthesia | Nervous system disorders |
|
| Parkinson's disease | Nervous system disorders |
|
| Speech disorder | Nervous system disorders |
|
| Syncope | Nervous system disorders |
|
| Tremor | Nervous system disorders |
|
| Cerebral microangiopathy | Nervous system disorders |
|
| Dysarthria | Nervous system disorders |
|
| Hypoaesthesia | Nervous system disorders |
|
| Memory impairment | Nervous system disorders |
|
| Movement disorder | Nervous system disorders |
|
| Nerve root lesion | Nervous system disorders |
|
| Sciatica | Nervous system disorders |
|
| Depression | Psychiatric disorders |
|
| Apathy | Psychiatric disorders |
|
| Anger | Psychiatric disorders |
|
| Anxiety | Psychiatric disorders |
|
| Confusional state | Psychiatric disorders |
|
| Depressed mood | Psychiatric disorders |
|
| Hallucination, auditory | Psychiatric disorders |
|
| Impulse-control disorder | Psychiatric disorders |
|
| Insomnia | Psychiatric disorders |
|
| Panic attack | Psychiatric disorders |
|
| Rapid eye movements sleep abnormal | Psychiatric disorders |
|
| Urinary tract infection | Reproductive system and breast disorders |
|
| Bronchitis | Infections and infestations |
|
| Ear infection | Infections and infestations |
|
| Incision site infection | Infections and infestations |
|
| Postoperative wound infection | Infections and infestations |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Bursitis | Musculoskeletal and connective tissue disorders |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders |
|
| Monarthritis | Musculoskeletal and connective tissue disorders |
|
| Neck pain | Musculoskeletal and connective tissue disorders |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders |
|
| Gait disturbance | General disorders |
|
| Adverse drug reaction | General disorders |
|
| Axillary pain | General disorders |
|
| Cyst | General disorders |
|
| Drug withdrawal syndrome | General disorders |
|
| Implant site haematoma | General disorders |
|
| Oedema peripheral | General disorders |
|
| Pyrexia | General disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders |
|
| Diabetes mellitus | Metabolism and nutrition disorders |
|
| Fluid retention | Metabolism and nutrition disorders |
|
| Folate deficiency | Metabolism and nutrition disorders |
|
| Hypertension | Vascular disorders |
|
| Hypotension | Vascular disorders |
|
| Thrombophlebitis | Vascular disorders |
|
| Diplopia | Eye disorders |
|
| Macular degeneration | Eye disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Laboratory test abnormal | Investigations |
|
| Weight increased | Investigations |
|
| Pericardial effusion | Cardiac disorders |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Urinary incontinence | Renal and urinary disorders |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
|
|
|
|
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| Title | Measurements |
|---|---|
|