Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Boston Scientific Corporation
Study ID
NCT03664609
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation — DEVICE
    Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.

Study Details

The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Key Dates

Start date
Mar 12, 2019
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: Parkinson's Disease
    Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System
  • Arm: Essential Tremor
    Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System
  • Arm: Dystonia
    Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System

Primary Outcome Measure

Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline [ Time Frame: 5 yrs. post implant ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital & Medical CenterPhoenixArizona85013
Boston Scientific Clinical Research Manager
855-213-9890
University of California, San FranciscoSan FranciscoCalifornia94143
Boston Scientific Clinical Research Manager
855-213-9890
University of Miami HospitalMiamiFlorida33136
Boston Scientific Clinical Research Manager
855-213-9890
University of South FloridaTampaFlorida33612
Boston Scientific Clinical Research Manager
855-213-9890
St. Luke's Regional Medical CenterBoiseIdaho83712
Boston Scientific Clinical Research
855-213-9890
Albany Medical CenterAlbanyNew York12208
Boston Scientific Clinical Research Manager
855-213-9890
Wake Forest University School of MedicineWinston-SalemNorth Carolina27157
Boston Scientific Clinical Research Manager
855-213-9890
Allegheny General HospitalPittsburghPennsylvania15212
Boston Scientific Clinical Research Manager
855-213-9890
Swedish Neuroscience InstituteSeattleWashington98122-

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