Cartesia eXTend 3D Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2025-01-28

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).

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Detailed Description

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

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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16-contact Directional Deep Brain Stimulation

Deep Brain Stimulation with a 16-contact Directional Lead

Group Type EXPERIMENTAL

16-contact Directional Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation with 16-contact Directional Lead

Interventions

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16-contact Directional Deep Brain Stimulation

Deep Brain Stimulation with 16-contact Directional Lead

Intervention Type DEVICE

Eligibility Criteria

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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.).

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No