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CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

NCT ID: NCT01896115

Last Updated: 2020-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

Brief Summary

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The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.

Detailed Description

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The study is a prospective, multi-center, double-blind, randomized controlled trial.

This study will compare various program settings for the bilateral stimulation of the STN using the BSC implantable Vercise™ DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic PD.

Conditions

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Parkinson's Disease

Keywords

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Stimulation, implantable pulse generator, deep brain stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Short PW

Patients with a Vercise DBS system programmed to 30 microseconds pulse width

Group Type EXPERIMENTAL

Vercise DBS settings

Intervention Type DEVICE

Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

Conventional PW

Patients with a Vercise DBS system programmed to 60 microseconds pulse width

Group Type EXPERIMENTAL

Vercise DBS settings

Intervention Type DEVICE

Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

Ventral current steering

Patients with a Vercise DBS system programmed to steer current ventrally

Group Type EXPERIMENTAL

Vercise DBS settings

Intervention Type DEVICE

Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

Dorsal current steering

Patients with a Vercise DBS system programmed to steer current dorsally.

Group Type EXPERIMENTAL

Vercise DBS settings

Intervention Type DEVICE

Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

Interventions

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Vercise DBS settings

Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
* UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
* DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
* Medical and mental fitness to comply with programming visit and study related procedures.
* Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
* Off symptom rigidity score of ≥2 in the evaluated arm as determined by the UPDRS-III.

Exclusion Criteria

* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months.
* Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roshini Jain

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

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Boston Scientific Clinical Research Information toll free number

Valencia, California, United States

Site Status

A.o. LKH Univ.-Kliniken Innsbruck

Innsbruck, , Austria

Site Status

University Berlin, Charite Virchow

Berlin, , Germany

Site Status

Uniklinik Köln

Cologne, , Germany

Site Status

Universitaetsklinikum Dusseldorf

Düsseldorf, , Germany

Site Status

Universitatsklinikum Campus Kiel

Kiel, , Germany

Site Status

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status

Osp. S. Maria Della Misericordia

Udine, , Italy

Site Status

Southmead Hospital Bristol

Bristol, , United Kingdom

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Countries

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United States Austria Germany Italy United Kingdom

Other Identifiers

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CDM00060272

Identifier Type: OTHER

Identifier Source: secondary_id

A4009

Identifier Type: -

Identifier Source: org_study_id