NCT03037398

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

8.2 years

First QC Date

January 12, 2017

Last Update Submit

April 2, 2025

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

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

    at least four months post implant

Study Arms (2)

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

Vercise Deep Brain Stimulation SystemDEVICE
Novel ArmStandard of Care Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Berlin, Charite Virchow Standort, Wedding

Berlin, Germany

Location

Universitaetsklinik Eppendorf

Hamburg, Germany

Location

Universitätsklinikum Campus Kiel

Kiel, Germany

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Natalie Bloom Lyons

    Boston Scientific Neuromodulation Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 31, 2017

Study Start

January 11, 2017

Primary Completion

April 2, 2025

Study Completion

April 2, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)