Status:
COMPLETED
CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 implantabl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01896115
Start Date
June 1 2013
End Date
December 1 2014
Last Update
November 19 2020
Active Locations (10)
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1
Boston Scientific Clinical Research Information toll free number
Valencia, California, United States, 91355
2
A.o. LKH Univ.-Kliniken Innsbruck
Innsbruck, Austria
3
University Berlin, Charite Virchow
Berlin, Germany
4
Uniklinik Köln
Cologne, Germany