ClinicalTrials.gg
RecruitingNCT04032470Updated Oct 13, 2026

Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)

An observational study in Essential Tremor, sponsored by Boston Scientific Corporation. Recruiting at 20 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Boston Scientific Corporation · Observational

From the registry’s dates

  • Started Oct 2019; still recruiting 7 years later.
Updated Oct 13, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor.

Read the detailed description

To compile characteristics of real-world outcomes using Deep Brain Stimulation (DBS) for the treatment of Essential Tremor to add to the evidence available for treatment of ET.

02

Conditions studied

  • Essential Tremor

Browse trials for

Keywords

  • Deep Brain Stimulation
  • Boston Scientific
  • Essential Tremor
03

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 500 is above the median of 89 across 70 observational studies indexed under Essential Tremor.

Browse Essential Tremor 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
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Subjects with Essential Tremor

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

  • Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor
  • Is at least 18 years old

Exclusion criteria

Exclusion Criteria:

  • Meets any in locally applicable Directions for Use
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Essential Tremor

    Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems

    Device: Deep Brain Stimulation Systems (DBS)

Interventions

  • DeviceDeep Brain Stimulation Systems (DBS)

    Subjects receiving DBS implant for treatment of Essential Tremor

06

What researchers measure

Primary outcomes

  1. Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST)

    Change in quality of life over the course of the study using QUEST

    Time frame: Up to 3 years

Other outcomes

  1. Change in tremor scores during the study as compared with baseline as assessed by Fahn-Tolosa- Marin Rating Scale

    Improvement in tremor scores as assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) during the study as compared with baseline

    Time frame: Up to 3 years

  2. Impression of Change scores during the study using Global Impression of Change

    Impression of Change scores during the study using Global Impression of Change

    Time frame: Up to 3 years

07

Study locations

18 of 20 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2019 (actual). Primary completion is estimated for Dec 2039, 242 months after the start.

Of 26 observational studies under Essential Tremor, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25. This study's planned 242 months is above that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: primary completion Dec 2029 → Dec 2039 and completion Dec 2029 → Dec 2039.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Jul 8, 2019
First posted
Jul 25, 2019
StartActual
Oct 23, 2019
Primary completionEst.
Dec 2039was Dec 2029
CompletionEst.
Dec 2039was Dec 2029
Last update
Oct 13, 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.
Primary completion
Dec 2029→Dec 2039
Oct 13, 2026
Study completion
Dec 2029→Dec 2039
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Primary completion Dec 2029→Dec 2039
    Study completion Dec 2029→Dec 2039
    + 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 ↗

09

Registry details

Key details

Study ID
NCT04032470
Responsible party
Sponsor
First posted
Jul 25, 2019
Start date
Oct 23, 2019
Primary completion
Dec 2039 (estimated)
Completion
Dec 2039 (estimated)
Last update
Oct 13, 2026

Study contacts

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

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion