Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Vercise Deep Brain Stimulation System

• Registration Number: NCT03037398
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Status Verified: 2025-04
• Primary Completion: 2025-04-02
• Study Completion: 2025-04-02
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard of Care Arm	Vercise Deep Brain Stimulation System	Programming completed as Standard of care
Novel Arm	Vercise Deep Brain Stimulation System	Programming completed by a novel method

Primary Outcome Measures

Name	Time	Method
Difference in time to program between the two arms at Programming Visit	at least four months post implant

Trial Locations

Locations (3)

University Berlin, Charite Virchow Standort, Wedding; 🇩🇪 Berlin, Germany

Universitaetsklinik Eppendorf; 🇩🇪 Hamburg, Germany

Universitätsklinikum Campus Kiel; 🇩🇪 Kiel, Germany