NCT03664609

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
6 countries

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Mar 2019Dec 2028

First Submitted

Initial submission to the registry

August 31, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

9.7 years

First QC Date

August 31, 2018

Last Update Submit

May 5, 2026

Conditions

Parkinson DiseaseEssential TremorDystonia

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline

    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

Study Arms (3)

Parkinson's Disease

Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System

Device: Deep Brain Stimulation

Essential Tremor

Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System

Device: Deep Brain Stimulation

Dystonia

Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System

Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE

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

DystoniaEssential TremorParkinson's Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Miami Hospital

Miami, Florida, 33136, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

COMPLETED

AZ St. Lucas

Ghent, Belgium

RECRUITING

AZ Delta

Roeselare, Belgium

RECRUITING

Hopital Fondation Adolphe de Rothschild

Paris, France

RECRUITING

Uniklinik Köln

Cologne, Germany

RECRUITING

Universitaetsklinikum Dusseldorf

Düsseldorf, Germany

RECRUITING

Uniklinikum Jena

Jena, Germany

COMPLETED

Universitaetsklinikum Schleswig-Holstein

Lübeck, Germany

RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, Germany

RECRUITING

Fondazione Istituto Neurologico Casimiro Mondino

Pavia, Italy

RECRUITING

Hospital Virgen Del Rocio

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseEssential TremorDystonia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Natalie Bloom Lyons

    Boston Scientific Neuromodulation Corporation

    STUDY DIRECTOR

Central Study Contacts

Cleo Mertz

CONTACT

855-213-9890BSNClinicalTrials@bsci.com

Diane Keesey

CONTACT

855-213-9890BSNClinicalTrials@bsci.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 10, 2018

Study Start

March 12, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)DE(5)FR(1)ES(1)IT(1)US(9)