Clinical trial NCT01896115: CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation
Official title: Current Steering to Optimize Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Stimulation, implantable pulse generator, deep brain stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic Window
timeFrame: Day 1 programming visit
measure: Unified Parkinson's Disease Rating Scale III
timeFrame: Day 1 programming visit
Secondary outcomes:
measure: Side Effect Thresholds - Single Contact vs. Steering
timeFrame: Day 1 programming visit
measure: Resting Tremor Severity - Single Contact vs. Steering
timeFrame: Day 1 programming visit
measure: Finger Tapping Amplitude - Single Contact vs. Steering
timeFrame: Day 1 programming visit
Other outcomes:
measure: Dorsal-Ventral Current Steering Therapeutic Window
timeFrame: Day 1 programming visit
measure: Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering
timeFrame: Day 1 programming Visit
measure: Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering
timeFrame: Day 1 programming visit
Locations:
city: Valencia
country: United States
facility: Boston Scientific Clinical Research Information toll free number
state: California
city: Innsbruck
country: Austria
facility: A.o. LKH Univ.-Kliniken Innsbruck
city: Berlin
country: Germany
facility: University Berlin, Charite Virchow
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Kiel
country: Germany
facility: Universitatsklinikum Campus Kiel
city: Köln
country: Germany
facility: Uniklinik Köln
city: Wurzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Udine
country: Italy
facility: Osp. S. Maria Della Misericordia
city: Bristol
country: United Kingdom
facility: Southmead Hospital Bristol
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References: