Cartesia eXTend 3D Study

Boston Scientific Corporation58 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

16-contact Directional Deep Brain StimulationDEVICE

Deep Brain Stimulation with 16-contact Directional Lead

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

University Berlin, Charite Virchow Standort, Wedding

Berlin, Germany

Uniklinik Koeln

Cologne, Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitaetsklinikum Giessen und Marburg GmbH

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks post device-activation

Secondary Outcomes

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.

Time frame: 26 weeks post device-activation

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.

Time frame: 52 weeks post device-activation

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.

Time frame: 12 weeks post device-activation

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.

Time frame: 26 weeks post device-activation

Data from ClinicalTrials.gov

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