Cartesia eXTend 3D Study

Boston Scientific

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: 16-contact Directional Deep Brain Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04577651

A4092

Details and patient eligibility

About

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).

Full description

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

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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