Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation (DIRECT-DBS)

Boston Scientific

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: BSC Deep Brain Stimulation System with Directional Lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT02835274

A4150

Details and patient eligibility

About

The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.

Enrollment

12 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
UPDRS III score of >25 in the meds OFF condition
Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score

Key Exclusion Criteria:

Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
Any current drug or alcohol abuse as determined by the investigator
Any history of recurrent or unprovoked seizures
Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months