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NCT Number: NCT02071134

Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.

The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.

Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion Ineco-Research Facility, Buenos Aires, Argentina

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About this study

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.

Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Meets criteria established in locally applicable Vercise System Direction for Use
  • At least 18 years old

Key Exclusion Criteria:

  • Meets any contraindication in the Vercise System locally applicable Directions for Use

Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.

Treatment and study plan

Deep Brain Stimulation (DBS)

Device

Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.

Other names: Vercise DBS System, Boston Scientific

Primary outcomes

  1. Improvement in patient's quality of life (QoL) during the study as compared with baseline

    Time frame: up to 3 years

    Change in quality of life assessments during the study as compared with baseline

Other outcomes

  1. Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline

    Time frame: up to 3 years

    Change in patient's motor symptoms as determined by UPDRS during the study as compared with baseline

  2. Change in medication usage during the study as compared with baseline

    Time frame: up to 3 years

  3. Impression of change scores during the study as compared with baseline

    Time frame: 3 years

    Impression of change scores during the study as compared with baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Lewis

CONTACT

[email protected]

855-213-9890

Heleen Scholtes

CONTACT

[email protected]

855-213-9890

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2014
Primary completion
2038
Study completion
2038
First posted
Feb 25, 2014
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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