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

April 9, 2024 updated by: Boston Scientific Corporation
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany
        • Suspended
        • University Berlin, Charite Virchow Standort, Wedding
      • Hamburg, Germany
        • Recruiting
        • Universitaetsklinik Eppendorf
        • Contact:
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Campus Kiel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Novel Arm
Programming completed by a novel method
Device: Vercise Deep Brain Stimulation System
Other: Standard of Care Arm
Programming completed as Standard of care
Device: Vercise Deep Brain Stimulation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in time to program between the two arms at Programming Visit
Time Frame: at least four months post implant
at least four months post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Neuromodulation Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2017

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimated)

January 31, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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