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Cartesia eXTend 3D Study (eXTend 3D)

Primary Purpose

Parkinson Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
16-contact Directional Deep Brain Stimulation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Deep Brain Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Berlin, Charite Virchow Standort, Wedding
  • Universitaetsklinikum Freiburg
  • Uniklinik Koeln
  • Universitaetsklinikum Giessen und Marburg GmbH
  • Universitaetsklinikum Tuebingen
  • Universitaetsklinikum Wuerzburg
  • Academisch Medisch Centrum
  • UMC St. Radboud
  • St. Georges Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

16-contact Directional Deep Brain Stimulation

Arm Description

Deep Brain Stimulation with a 16-contact Directional Lead

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 and 52 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.
Change in Quality of Life
Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks, 26 weeks and 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.

Full Information

First Posted
September 26, 2020
Last Updated
October 9, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04577651
Brief Title
Cartesia eXTend 3D Study
Acronym
eXTend 3D
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
April 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
16-contact Directional Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Deep Brain Stimulation with a 16-contact Directional Lead
Intervention Type
Device
Intervention Name(s)
16-contact Directional Deep Brain Stimulation
Intervention Description
Deep Brain Stimulation with 16-contact Directional Lead
Primary Outcome Measure Information:
Title
Change in motor function
Description
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.
Time Frame
12 weeks post device-activation
Secondary Outcome Measure Information:
Title
Change in motor function
Description
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 and 52 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.
Time Frame
26 and 52 weeks post device-activation
Title
Change in Quality of Life
Description
Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks, 26 weeks and 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.
Time Frame
12, 26 and 52 weeks post device-activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Bloom Lyons
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University Berlin, Charite Virchow Standort, Wedding
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Uniklinik Koeln
City
Koeln
Country
Germany
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH
City
Marburg
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg
City
Würzburg
Country
Germany
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
Country
Netherlands
Facility Name
St. Georges Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

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Cartesia eXTend 3D Study

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