Cartesia eXTend 3D Study

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

Official Title
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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)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: 16-contact Directional Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16-contact Directional Deep Brain Stimulation<br>Deep Brain Stimulation with a 16-contact Directional Lead | Device: 16-contact Directional Deep Brain Stimulation<br>* Deep Brain Stimulation with 16-contact Directional Lead<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 26 and 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, 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. | 12, 26 and 52 weeks post device-activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation