Deep Brain Stimulation (DBS) Retrospective Outcomes Study

June 10, 2026 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium
        • Recruiting
        • AZ St. Lucas
        • Contact:
      • Roeselare, Belgium
        • Recruiting
        • AZ Delta
        • Contact:
  • France
      • Paris, France
        • Recruiting
        • Hopital Fondation Adolphe de Rothschild
        • Contact:
  • Germany
      • Cologne, Germany
        • Recruiting
        • Uniklinik Köln
        • Contact:
      • Düsseldorf, Germany
        • Recruiting
        • Universitaetsklinikum Dusseldorf
        • Contact:
      • Jena, Germany
        • Completed
        • Uniklinikum Jena
      • Lübeck, Germany
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein
        • Contact:
      • Würzburg, Germany
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
  • Italy
      • Pavia, Italy
        • Recruiting
        • Fondazione Istituto Neurologico Casimiro Mondino
        • Contact:
  • Spain
      • Seville, Spain
        • Recruiting
        • Hospital Virgen Del Rocio
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • St. Joseph's Hospital & Medical Center
        • Contact:
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • St. Luke's Regional Medical Center
        • Contact:
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University School of Medicine
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122
        • Completed
        • Swedish Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects' chart data will be drawn from the Investigator's standard patient pool treated at his/her practice.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No Exclusion Criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's Disease
Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System
Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.
Essential Tremor
Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System
Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.
Dystonia
Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System
Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
5 yrs. post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Neuromodulation Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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