Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT01839396
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.

GUIDE XT may be used for planning of programming as needed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-24
• Study Start: 2013-05-17
• Primary Completion: 2016-12-27
• Results First Submitted: 2018-02-16
• Results First Submitted QC: 2018-07-18
• Results First Posted: 2018-08-15
• Study Completion: 2022-12-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium continuous dose of stimulation	Deep Brain 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.
Low intermittent dose of stimulation	Deep Brain 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.

Primary Outcome Measures

Name	Time	Method
Change in ON Time as Measured by Parkinson's Disease Diary	From baseline to 12 weeks post-randomization	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

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints	From baseline to 12 weeks post-randomization	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.

Trial Locations

Locations (22)

Carepoint, PC d/b/a Blue Sky Neurology; 🇺🇸 Englewood, Colorado, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Florida Shands Hospital; 🇺🇸 Gainesville, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Mayo Clinic, Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

NYU Medical Center; 🇺🇸 New York, New York, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

Allegheny Health Network; 🇺🇸 Pittsburgh, Pennsylvania, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Muhammad Ali Parkinson Research Center and Movement Disorders Clinic; 🇺🇸 Phoenix, Arizona, United States

Kaiser Permanente, Sacramento; 🇺🇸 Sacramento, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Miami, School of Medicine; 🇺🇸 Miami, Florida, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, 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