Parkinson's Disease Clinical Trial
— INTREPIDOfficial title:
Implantable Neurostimulator for the Treatment of Parkinson's Disease
Verified date | July 2023 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 313 |
Est. completion date | December 5, 2022 |
Est. primary completion date | December 27, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 75 Years |
Eligibility | Key Inclusion Criteria: - Diagnosis of bilateral idiopathic PD (H&Y = 2) with a duration of PD = 5 years. - Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy. - Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. Key Exclusion Criteria: - Any intracranial abnormality or medical condition that would contraindicate DBS surgery. - Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol - Any other active implanted devices including neurostimulators and /or drug delivery pumps - Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure. - Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. - A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception. |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical Center | Albany | New York |
United States | Emory University | Atlanta | Georgia |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Carepoint, PC d/b/a Blue Sky Neurology | Englewood | Colorado |
United States | University of Florida Shands Hospital | Gainesville | Florida |
United States | Mayo Clinic, Jacksonville | Jacksonville | Florida |
United States | University of Kansas Hospital | Kansas City | Kansas |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | University of Miami, School of Medicine | Miami | Florida |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Vanderbilt University | Nashville | Tennessee |
United States | NYU Medical Center | New York | New York |
United States | Muhammad Ali Parkinson Research Center and Movement Disorders Clinic | Phoenix | Arizona |
United States | Allegheny Health Network | Pittsburgh | Pennsylvania |
United States | Kaiser Permanente, Sacramento | Sacramento | California |
United States | University of Utah | Salt Lake City | Utah |
United States | University of California, San Francisco | San Francisco | California |
United States | Wake Forest Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | From baseline to 12 weeks post-randomization | |
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. |
From baseline to 12 weeks post-randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
Terminated |
NCT02924194 -
Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease
|
N/A | |
Completed |
NCT02874274 -
Vaccination Uptake (VAX) in PD
|
N/A |