Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Recruiting

• Conditions: Dystonia; Parkinson Disease; Essential Tremor
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT03664609
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

The purpose of this study is to characterize

1. real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-10
• Study Start: 2019-03-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-12
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Must be previously treated with or eligible for implantation with a deep brain stimulation system

Exclusion Criteria

• No Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's Disease	Deep Brain Stimulation	Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System
Dystonia	Deep Brain Stimulation	Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System
Essential Tremor	Deep Brain Stimulation	Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System

Primary Outcome Measures

Name	Time	Method
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline	5 yrs. post implant	Improvement in disease symptoms as assessed by Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline

Trial Locations

Locations (18)

Fondazione Istituto Neurologico Casimiro Mondino; 🇮🇹 Pavia, Italy

St. Joseph's Hospital & Medical Center; 🇺🇸 Phoenix, Arizona, United States

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

University of Miami Hospital; 🇺🇸 Miami, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

St. Luke's Regional Medical Center; 🇺🇸 Boise, Idaho, United States

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

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Swedish Neuroscience Institute; 🇺🇸 Seattle, Washington, United States

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