Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation (CLOVER)

Boston Scientific

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Vercise Deep Brain Stimulation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03037398

A4063

Details and patient eligibility

About

The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Implanted bilaterally in STN or GPi with a Vercise™ DBS system for Parkinson's disease, including directional leads, for at least four months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
• Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
• Be at least 18 years of age.
• Device must have been implanted on label or must be on label by the time the subject gets enrolled.

Key Exclusion Criteria:

• Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Novel Arm

Active Comparator group

Description:

Programming completed by a novel method

Treatment:

Device: Vercise Deep Brain Stimulation System

Standard of Care Arm

Other group

Description:

Programming completed as Standard of care

Treatment:

Device: Vercise Deep Brain Stimulation System