Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
NCT ID: NCT01839396
Last Updated: 2023-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
313 participants
INTERVENTIONAL
2013-05-17
2022-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Medium continuous dose of stimulation
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.
Deep Brain Stimulation
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.
Low intermittent dose of stimulation
Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective.
Deep Brain Stimulation
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.
Interventions
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Deep Brain Stimulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
22 Years
75 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jerrold Vitek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota, Neurology Department
Philip Starr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiry of California, San Francisco, Surgical Movement Disorders Clinic
Locations
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Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente, Sacramento
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, 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 Miami, School of Medicine
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, United States
Albany Medical Center
Albany, New York, United States
NYU Medical Center
New York, New York, United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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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.
Other Identifiers
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CDM00049710/90876693
Identifier Type: OTHER
Identifier Source: secondary_id
G120075
Identifier Type: -
Identifier Source: org_study_id
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