Cartesia eXTend 3D Study

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
16-contact Directional Deep Brain Stimulation	16-contact Directional Deep Brain Stimulation	Deep Brain Stimulation with a 16-contact Directional Lead

Primary Outcome Measures

Name	Time	Method
Change in Motor Function	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.

Secondary Outcome Measures

Name	Time	Method
Change in Motor Function	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.
Change in Quality of Life	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.

Locations (10): Uniklinik Koeln
🇩🇪
Koeln, Germany
University Berlin, Charite Virchow Standort, Wedding
🇩🇪
Berlin, Germany
Universitaetsklinikum Freiburg
🇩🇪
Freiburg, Germany
Universitaetsklinikum Giessen und Marburg GmbH
🇩🇪
Marburg, Germany
Universitaetsklinikum Tuebingen
🇩🇪
Tuebingen, Germany
Universitaetsklinikum Wuerzburg
🇩🇪
Würzburg, Germany
Academisch Medisch Centrum
🇳🇱
Amsterdam, Netherlands
St. Georges Hospital
🇬🇧
London, United Kingdom
John Radcliffe Hospital
🇬🇧
Oxford, United Kingdom
UMC St. Radboud
🇳🇱
Nijmegen, Netherlands