Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Berlin, Charite Virchow Standort, Wedding, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vercise Deep Brain Stimulation System

Device

Primary outcomes

Difference in time to program between the two arms at Programming Visit

Time frame: at least four months post implant

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: CLOVER

Important dates

Study start: 2017
Primary completion: 2025
Study completion: 2025
First posted: Jan 31, 2017
Registry last updated: Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed