Completed

eXTend 3DStudy 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)

What is being tested

16-contact Directional Deep Brain Stimulation

Device

Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

Over 18 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: November 2020

See protocol details

Summary

Principal SponsorBoston Scientific Corporation

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 2, 2020

Actual date on which the first participant was enrolled.

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

Official TitleStudy 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)

NCT04577651

Principal SponsorBoston Scientific Corporation

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

58 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

4 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Deep Brain Stimulation with a 16-contact Directional Lead

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Suspended

University Berlin, Charite Virchow Standort, Wedding

Berlin, GermanyOpen University Berlin, Charite Virchow Standort, Wedding in Google Maps

Suspended

Uniklinik Koeln

Cologne, Germany

Suspended

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Suspended

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, Germany

Completed10 Study Centers