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| ID | Type | Description | Link |
|---|---|---|---|
| CDM00049710/90876693 | Other Identifier | BSC protocol number |
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The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.
GUIDE XT may be used for planning of programming as needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medium continuous dose of stimulation | Active Comparator | Subjects in this arm will receive stimulation settings at a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients. |
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| Low intermittent dose of stimulation | Sham Comparator | Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | The Vercise™ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ON Time as Measured by Parkinson's Disease Diary | Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement | From baseline to 12 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints | Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization. Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state. | From baseline to 12 weeks post-randomization |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrold Vitek, MD, PhD | University of Minnesota, Neurology Department | Principal Investigator |
| Philip Starr, MD, PhD | Universiry of California, San Francisco, Surgical Movement Disorders Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhammad Ali Parkinson Research Center and Movement Disorders Clinic | Phoenix | Arizona | 85013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32470421 | Derived | Vitek JL, Jain R, Chen L, Troster AI, Schrock LE, House PA, Giroux ML, Hebb AO, Farris SM, Whiting DM, Leichliter TA, Ostrem JL, San Luciano M, Galifianakis N, Verhagen Metman L, Sani S, Karl JA, Siddiqui MS, Tatter SB, Ul Haq I, Machado AG, Gostkowski M, Tagliati M, Mamelak AN, Okun MS, Foote KD, Moguel-Cobos G, Ponce FA, Pahwa R, Nazzaro JM, Buetefisch CM, Gross RE, Luca CC, Jagid JR, Revuelta GJ, Takacs I, Pourfar MH, Mogilner AY, Duker AP, Mandybur GT, Rosenow JM, Cooper SE, Park MC, Khandhar SM, Sedrak M, Phibbs FT, Pilitsis JG, Uitti RJ, Starr PA. Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study. Lancet Neurol. 2020 Jun;19(6):491-501. doi: 10.1016/S1474-4422(20)30108-3. Epub 2020 May 26. |
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Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and randomization for study endpoints
Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and randomization for study endpoints
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| ID | Title | Description |
|---|---|---|
| FG000 | Medium Continuous Dose of Stimulation | Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients. Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cedars-Sinai Medical Center |
| Los Angeles |
| California |
| 90048 |
| United States |
| Kaiser Permanente, Sacramento | Sacramento | California | 95825 | United States |
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| Carepoint, PC d/b/a Blue Sky Neurology | Englewood | Colorado | 80113 | United States |
| University of Florida Shands Hospital | Gainesville | Florida | 32610 | United States |
| Mayo Clinic, Jacksonville | Jacksonville | Florida | 32224 | United States |
| University of Miami, School of Medicine | Miami | Florida | 33136 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| NYU Medical Center | New York | New York | 10016 | United States |
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45129 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| FG001 | Low Intermittent Dose of Stimulation | Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective. Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Medium Continuous Dose of Stimulation | Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients. Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period. |
| BG001 | Low Intermittent Dose of Stimulation | Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective. Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age is reported at time of enrollment | Information for each group and overall population is provided. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 ON Time as Measured by Parkinson's Disease Diary | Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement | Posted | Mean | Standard Deviation | hours | From baseline to 12 weeks post-randomization |
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| Secondary | Secondary Endpoints | Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization. Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state. | Posted | Mean | Standard Deviation | units on a scale | From baseline to 12 weeks post-randomization |
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Adverse event data was collected up to 12 weeks and up to Dec 2016.
Serious Adverse Events related to hardware, stimulation or procedure are reported
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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 | Medium Continuous Dose of Stimulation | Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients. Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period. | 0 | 121 | 14 | 121 | 35 | 121 |
| EG001 | Low Intermittent Dose of Stimulation | Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective. Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters were varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period. | 0 | 39 | 4 | 39 | 4 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphasia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Confusional postoperative | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Convulsion | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Device related Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Implant Site Edema | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Implant Site Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Intracranial hypotension | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Pneumocephalus | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Staphylococcal Skin infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Wound Heamorhage | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Balance Disorder | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Implant Site Edema | General disorders | MedDRA (10.0) | Systematic Assessment |
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Clinical Study Agreement that restricts the PIs until official study manuscript is published.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roshini Jain, Director of Clinical Sciences | Boston Scientific | 6619494355 | roshini.jain@bsci.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D004358 | Drug Therapy |
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| Male |
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| Participants |
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