Parkinson DiseaseeXTend 3DNCT04577651

Cartesia eXTend 3D Study

A study testing 16-contact Directional Deep Brain Stimulation in people with Parkinson Disease, run by Boston Scientific Corporation at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: 16-contact Directional Deep Brain Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 10 sitesin 3 countries
Study dates: 2 Nov 2020to 28 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Candidate for DBS implant in the treatment of Parkinson's disease
Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent
Persistent disabling Parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy
Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.).

Who cannot join

Any intracranial abnormality or medical condition that would contraindicate DBS surgery
Have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)
Any current drug or alcohol abuse, as determined by the investigator
Any history of recurrent or unprovoked seizures

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

Germany6 sites

University Berlin, Charite Virchow Standort, Wedding
Berlin
Uniklinik Koeln
Cologne
Universitaetsklinikum Freiburg
Freiburg im Breisgau
Universitaetsklinikum Giessen und Marburg GmbH
Marburg
Universitaetsklinikum Tuebingen
Tübingen
Universitaetsklinikum Wuerzburg
Würzburg

Other trials in Germany

Netherlands2 sites

Academisch Medisch Centrum
Amsterdam
UMC St. Radboud
Nijmegen

Other trials in Netherlands

United Kingdom2 sites

St. Georges Hospital
London, SW17 0QT
John Radcliffe Hospital
Oxford

Other trials in United Kingdom

About this study

Official title: Study to Evaluate Boston Scientific Vercise Cartesia 16-contact Directional Lead (X/HX) With Deep Brain Stimulation (DBS) Systems for the Treatment of Parkinson's Disease (PD)

Read the detailed description

Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease.

Conditions: Parkinson Disease
Being tested: 16-contact Directional Deep Brain Stimulation
Keywords: Deep Brain Stimulation
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

16-contact Directional Deep Brain StimulationDevice
Deep Brain Stimulation with 16-contact Directional Lead

Study groups in NCT04577651
Study group	Role	What they receive
16-contact Directional Deep Brain Stimulation	Experimental	Deep Brain Stimulation with a 16-contact Directional Lead Receives: Device: 16-contact Directional Deep Brain Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Motor Function
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline in meds off condition to 12 weeks post device-activation in stim on/meds off condition. Range 0 - 108. Higher scores indicate worse function.
Measured: 12 weeks post device-activation

Secondary outcomes (5)

Change in Motor Function
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 26 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.
Measured: 26 weeks post device-activation
Change in Motor Function
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 52 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.
Measured: 52 weeks post device-activation
Change in Quality of Life
Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.
Measured: 12 weeks post device-activation
Change in Quality of Life
Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 26 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.
Measured: 26 weeks post device-activation
Change in Quality of Life
Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 52 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.
Measured: 52 weeks post device-activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 202028 Jan 2025

First posted8 Oct 2020
Study start2 Nov 2020
Primary completion27 Feb 2023
Study completion28 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04577651
Sponsor's protocol ID: A4092
Acronym: eXTend 3D
Status last verified: Feb 2025
First submitted: 26 Sep 2020
Last updated: 21 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Evaluate Boston Scientific Vercise Cartesia 16-contact Directional Lead (X/HX) With Deep Brain Stimulation (DBS) Systems for the Treatment of Parkinson's Disease (PD)
ClinicalTrials.gov ID: NCT04577651
Acronym / sponsor ID: eXTend 3D / A4092
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 2 Nov 2020 (actual)
Primary completion: 27 Feb 2023 (actual)
Study completion: 28 Jan 2025 (actual)
First posted: 8 Oct 2020 (actual)
Results: Posted 29 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
16-contact Directional Deep Brain Stimulation	Experimental	Device: 16-contact Directional Deep Brain StimulationDeep Brain Stimulation with a 16-contact Directional Lead

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Candidate for DBS implant in the treatment of Parkinson's disease
Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent
Persistent disabling Parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy
Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.).

Key exclusion criteria (4 listed)

Any intracranial abnormality or medical condition that would contraindicate DBS surgery
Have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders)
Any current drug or alcohol abuse, as determined by the investigator
Any history of recurrent or unprovoked seizures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
16-contact Directional Deep Brain StimulationDeep Brain Stimulation with 16-contact Directional Lead	Device	16-contact Directional Deep Brain Stimulation

Primary outcome

Change in Motor Function
Time frame: 12 weeks post device-activation
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline in meds off condition to 12 weeks post device-activation in stim on/meds off condition. Range 0 - 108. Higher scores indicate worse function.

5 secondary outcomes

Change in Motor Function
Time frame: 26 weeks post device-activation
Change in Motor Function
Time frame: 52 weeks post device-activation
Change in Quality of Life
Time frame: 12 weeks post device-activation
Change in Quality of Life
Time frame: 26 weeks post device-activation
Change in Quality of Life
Time frame: 52 weeks post device-activation

Results and safety

Results posted to the registry on 29 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
16-contact Directional Deep Brain Stimulation	58	45

Primary outcome: Change in Motor Function

Time frame: 12 weeks post device-activation. Mean (Standard Deviation). Unit: units on a scale

Measure	16-contact Directional Deep Brain Stimulation n = 49
Value	-19.9 (12.8)

Population analysed: Intent to treat population.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event Rates for all Subjects through the week 52 visit, approximately 14 months post informed consent.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
16-contact Directional Deep Brain Stimulation	14 of 58 (24.1%)	25 of 58 (43.1%)	1 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Natalie Bloom Lyons study director

Boston Scientific Neuromodulation Corporation

10 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 16-contact Directional Deep Brain Stimulation in people with Parkinson Disease, run by Boston Scientific Corporation at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Motor Function (time frame: 12 weeks post device-activation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04577651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.