Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ring mode followed by Unrestricted mode | Experimental | omni-directional stimulation followed by unrestricted Mode stimulation |
|
| Unrestricted mode followed by ring mode | Active Comparator | Unrestricted Mode stimulation followed by omni-directional stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BSC Deep Brain Stimulation System with Directional Lead | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase | Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state | Up to 12 months post-implant |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roshini Jain | Boston Scientific Neuromodulation Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble - Hopital Michallon | Grenoble | France | ||||
| Universitaetsklinikum Wuerzburg |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ring Mode Followed by Unrestricted Mode | omni-directional stimulation followed by unrestricted Mode stimulation BSC Deep Brain Stimulation System with Directional Lead |
| FG001 | Unrestricted Mode Followed by Ring Mode | Unrestricted Mode stimulation followed by omni-directional stimulation BSC Deep Brain Stimulation System with Directional Lead |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ring Mode Followed by Unrestricted Mode | omni-directional stimulation followed by unrestricted Mode stimulation BSC Deep Brain Stimulation System with Directional Lead |
| BG001 | Unrestricted Mode Followed by Ring Mode |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase | Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state | Posted | Mean | Standard Deviation | units on a scale | Up to 12 months post-implant |
|
Adverse events up to end of randomized phase (~ up to 120 days post implant)
Adverse events up to end of randomized phase
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ring Mode | Ring Mode BSC Deep Brain Stimulation System with Directional Lead |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Sciences | Boston Scientific | 6619494350 | roshini.jain@bsci.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2016 | Jan 27, 2020 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Würzburg |
| Germany |
| Academisch Medisch Centrum | Amsterdam | Netherlands |
Unrestricted Mode stimulation followed by omni-directional stimulation
BSC Deep Brain Stimulation System with Directional Lead
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Unrestricted Mode | Unrestricted mode BSC Deep Brain Stimulation System with Directional Lead | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |