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The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD).
Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Experimental | Deep Brain Stimulation with a 16-contact Directional Lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Device | Deep Brain Stimulation with 16-contact Directional Lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Function | Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline in meds off condition to 12 weeks post device-activation in stim on/meds off condition. Range 0 - 108. Higher scores indicate worse function. | 12 weeks post device-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Function | Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 26 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function. | 26 weeks post device-activation |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Neuromodulation Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Berlin, Charite Virchow Standort, Wedding | Berlin | Germany | ||||
| Uniklinik Koeln |
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| ID | Title | Description |
|---|---|---|
| FG000 | 16-contact Directional Deep Brain Stimulation | Deep Brain Stimulation with a 16-contact Directional Lead 16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics of the Intent-to-Treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | 16-contact Directional Deep Brain Stimulation | Deep Brain Stimulation with a 16-contact Directional Lead 16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead |
| 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 | Change in Motor Function | Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline in meds off condition to 12 weeks post device-activation in stim on/meds off condition. Range 0 - 108. Higher scores indicate worse function. | Intent to treat population. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks post device-activation |
|
Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.
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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 | 16-contact Directional Deep Brain Stimulation | Deep Brain Stimulation with a 16-contact Directional Lead 16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enterovesical fistula | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Operations | Boston Scientific Corporation | 855-213-9890 | BSNClinicalTrials@bsci.com |
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| 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 | Apr 15, 2021 | Mar 27, 2024 | Prot_SAP_001.pdf |
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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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| Change in Motor Function |
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 52 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function. |
| 52 weeks post device-activation |
| Change in Quality of Life | Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health. | 12 weeks post device-activation |
| Change in Quality of Life | Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 26 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health. | 26 weeks post device-activation |
| Change in Quality of Life | Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 52 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health. | 52 weeks post device-activation |
| Cologne |
| Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Marburg | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | Germany |
| Universitaetsklinikum Wuerzburg | Würzburg | Germany |
| Academisch Medisch Centrum | Amsterdam | Netherlands |
| UMC St. Radboud | Nijmegen | Netherlands |
| St. Georges Hospital | London | SW17 0QT | United Kingdom |
| John Radcliffe Hospital | Oxford | United Kingdom |
| Physician Decision |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MDS-UPDRS-III score (meds off condition) | Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III. Range 0 - 108. Higher scores indicate worse function. | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Motor Function | Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 26 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function. | Intent to treat population | Posted | Mean | Standard Deviation | units on a scale | 26 weeks post device-activation |
|
|
|
| Secondary | Change in Motor Function | Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 52 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function. | Intent to treat population | Posted | Mean | Standard Deviation | score on a scale | 52 weeks post device-activation |
|
|
|
| Secondary | Change in Quality of Life | Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health. | Intent to Treat population | Posted | Mean | Standard Deviation | units on a scale | 12 weeks post device-activation |
|
|
|
| Secondary | Change in Quality of Life | Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 26 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health. | Intent to Treat population | Posted | Mean | Standard Deviation | units on a scale | 26 weeks post device-activation |
|
|
|
| Secondary | Change in Quality of Life | Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 52 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health. | Intent to Treat population | Posted | Mean | Standard Deviation | units on a scale | 52 weeks post device-activation |
|
|
|
| 1 |
| 58 |
| 14 |
| 58 |
| 25 |
| 58 |
| Ileus | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Implant site paraesthesia | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
|
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Cerebral Ischaemia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Fine motor skill dysfunction | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Hyperkinesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
|
| Dopamine dysregulation syndrome | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
|
| Impulse-control disorder | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Implant site pain | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |