Closed Loop Programming Evaluation Using External Respons... | NCT03037398

Studies
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation

NCT03037398

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Apr 3, 2025Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

Vercise Deep Brain Stimulation System

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2017Actual

Primary Completion Date

Apr 2, 2025Actual

Completion Date

Apr 2, 2025Actual

First Submitted Date

Jan 12, 2017

First Submission Date that Met QC Criteria

Jan 27, 2017

First Posted Date

Jan 31, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2025

Last Update Posted Date

Apr 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Novel Arm	Active Comparator	Programming completed by a novel method	Device: Vercise Deep Brain Stimulation System
Standard of Care Arm	Other	Programming completed as Standard of care	Device: Vercise Deep Brain Stimulation System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vercise Deep Brain Stimulation System	Device		Novel Arm Standard of Care Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Natalie Bloom Lyons	Boston Scientific Neuromodulation Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Berlin, Charite Virchow Standort, Wedding		Berlin			Germany
Universitaetsklinik Eppendorf

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 1, 2026
Reset	Apr 21, 2026
Release	May 11, 2026
Reset	Jun 4, 2026

Submission Tracking

Estimated Results First Submitted Date

Apr 1, 2026

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 1, 2026			Apr 21, 2026
May 11, 2026

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided