Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Parkinson Disease Clinical Trial

— CLOVER  

Official title:

Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03037398
• Other study ID #: A4063
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Heleen Scholtes
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Vercise Deep Brain Stimulation System

Locations

Country	Name	City	State
Germany	University Berlin, Charite Virchow Standort, Wedding	Berlin
Germany	Universitaetsklinik Eppendorf	Hamburg
Germany	Universitätsklinikum Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in time to program between the two arms at Programming Visit		at least four months post implant