Cartesia eXTend 3D Study

Parkinson Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04577651
• Other study ID #: A4092
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: April 2030

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: April 2030
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• 16-contact Directional Deep Brain Stimulation
Deep Brain Stimulation with 16-contact Directional Lead

Locations

Country	Name	City	State
Germany	University Berlin, Charite Virchow Standort, Wedding	Berlin
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	Uniklinik Koeln	Koeln
Germany	Universitaetsklinikum Giessen und Marburg GmbH	Marburg
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Universitaetsklinikum Wuerzburg	Würzburg
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	UMC St. Radboud	Nijmegen
United Kingdom	St. Georges Hospital	London
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	26 weeks post device-activation
Secondary	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.	52 weeks post device-activation
Secondary	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.	12 weeks post device-activation
Secondary	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.	26 weeks post device-activation
Secondary	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.	52 weeks post device-activation