NCT04577651

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 29, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

September 26, 2020

Results QC Date

February 26, 2024

Last Update Submit

February 7, 2025

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks post device-activation

Secondary Outcomes (5)

  • Change in Motor Function

    26 weeks post device-activation

  • Change in Motor Function

    52 weeks post device-activation

  • Change in Quality of Life

    12 weeks post device-activation

  • Change in Quality of Life

    26 weeks post device-activation

  • Change in Quality of Life

    52 weeks post device-activation

Study Arms (1)

16-contact Directional Deep Brain Stimulation

EXPERIMENTAL

Deep Brain Stimulation with a 16-contact Directional Lead

Device: 16-contact Directional Deep Brain Stimulation

Interventions

16-contact Directional Deep Brain StimulationDEVICE

Deep Brain Stimulation with 16-contact Directional Lead

16-contact Directional Deep Brain Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Berlin, Charite Virchow Standort, Wedding

Berlin, Germany

Location

Uniklinik Koeln

Cologne, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Location

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

UMC St. Radboud

Nijmegen, Netherlands

Location

St. Georges Hospital

London, SW17 0QT, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Sr. Director, Clinical Operations
Organization
Boston Scientific Corporation
BSNClinicalTrials@bsci.com
855-213-9890

Study Officials

  • Natalie Bloom Lyons

    Boston Scientific Neuromodulation Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2020

First Posted

October 8, 2020

Study Start

November 2, 2020

Primary Completion

February 27, 2023

Study Completion

January 28, 2025

Last Updated

February 21, 2025

Results First Posted

March 29, 2024

Record last verified: 2025-02

Locations

GB(2)DE(6)NL(2)