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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vercise Deep Brain Stimulation System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Implanted bilaterally in STN with a Vercise™ DBS system for Parkinson's disease 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.

Exclusion Criteria:

  • Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
  • Device must be implanted on label.

Sites / Locations

  • University Berlin, Charite Virchow Standort, WeddingRecruiting
  • Universitaetsklinik EppendorfRecruiting
  • Universitätsklinikum Campus KielRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Novel Arm

Standard of Care Arm

Arm Description

Programming completed by a novel method

Programming completed as Standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 12, 2017
Last Updated
October 3, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03037398
Brief Title
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
Acronym
CLOVER
Official Title
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novel Arm
Arm Type
Active Comparator
Arm Description
Programming completed by a novel method
Arm Title
Standard of Care Arm
Arm Type
Other
Arm Description
Programming completed as Standard of care
Intervention Type
Device
Intervention Name(s)
Vercise Deep Brain Stimulation System
Primary Outcome Measure Information:
Title
Difference in time to program between the two arms at Programming Visit
Time Frame
at least four months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Implanted bilaterally in STN with a Vercise™ DBS system for Parkinson's disease 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. Exclusion Criteria: Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator. Device must be implanted on label.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heleen Scholtes
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Keesey
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Bloom Lyons
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University Berlin, Charite Virchow Standort, Wedding
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Universitaetsklinik Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Universitätsklinikum Campus Kiel
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

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