Cartesia eXTend 3D Study (eXTend 3D)

February 7, 2025 updated by: Boston Scientific Corporation

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • University Berlin, Charite Virchow Standort, Wedding
      • Freiburg, Germany
        • Universitaetsklinikum Freiburg
      • Koeln, Germany
        • Uniklinik Koeln
      • Marburg, Germany
        • Universitaetsklinikum Giessen Und Marburg Gmbh
      • Tuebingen, Germany
        • Universitaetsklinikum Tuebingen
      • Würzburg, Germany
        • Universitaetsklinikum Wuerzburg
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum
      • Nijmegen, Netherlands
        • UMC St. Radboud
  • United Kingdom
      • London, United Kingdom, SW17 0QT
        • St. Georges Hospital
      • Oxford, United Kingdom
        • John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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:

  • 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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 16-contact Directional Deep Brain Stimulation
Deep Brain Stimulation with a 16-contact Directional Lead
Device: 16-contact Directional Deep Brain Stimulation
Deep Brain Stimulation with 16-contact Directional Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks post device-activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Motor Function
Time Frame: 26 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 (meds off) to 26 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.
26 weeks post device-activation
Change in Motor Function
Time Frame: 52 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 (meds off) to 52 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.
52 weeks post device-activation
Change in Quality of Life
Time Frame: 12 weeks post device-activation
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.
12 weeks post device-activation
Change in Quality of Life
Time Frame: 26 weeks post device-activation
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.
26 weeks post device-activation
Change in Quality of Life
Time Frame: 52 weeks post device-activation
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.
52 weeks post device-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Neuromodulation Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

January 28, 2025

Study Registration Dates

First Submitted

September 26, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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