ClinicalTrials.gg
RecruitingNCT03664609Updated Oct 7, 2026

Deep Brain Stimulation (DBS) Retrospective Outcomes Study

An observational study in Parkinson Disease, Essential Tremor and Dystonia, sponsored by Boston Scientific Corporation. Recruiting at 20 sites in 6 countries. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Boston Scientific Corporation · Observational

From the registry’s dates

  • Started Mar 2019; still recruiting 7 years 8 months later.
Updated Oct 7, 2026Site recruiting status changedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
5,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Essential Tremor
  • Dystonia
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 96 across 1,085 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No Exclusion Criteria
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
5,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceDeep Brain Stimulation

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

06

What researchers measure

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

    Time frame: 5 yrs. post implant

07

Study locations

16 of 20 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2019 (actual). Primary completion is estimated for Dec 2028, 117 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2018
First posted
Sep 10, 2018
StartActual
Mar 12, 2019
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
Albany Medical Center is now Completed
Oct 7, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Albany Medical Center · Albany, United StatesContact removed B•••@bsci.com · •••9890
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Albany Medical Center is now Completed
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Albany Medical Center · Albany, United StatesContact removed B•••@bsci.com · •••9890
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03664609
Responsible party
Sponsor
First posted
Sep 10, 2018
Start date
Mar 12, 2019
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 7, 2026

Study contacts

Cleo Mertz
Contact
BSNClinicalTrials@bsci.com
855-213-9890
Diane Keesey
Contact
BSNClinicalTrials@bsci.com
855-213-9890
Natalie Bloom Lyons
study director · Boston Scientific Neuromodulation Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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