CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

Completed · Not applicable

Conditions studied: Parkinson's Disease

In brief

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

Key facts

Study ID

NCT01896115

Run by

Boston Scientific Corporation

People needed

40

Starts

2013-06-01

Expected to finish

2014-12-01

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Boston Scientific Clinical Research Information toll free number — Valencia, California, United States
• A.o. LKH Univ.-Kliniken Innsbruck — Innsbruck, Austria
• University Berlin, Charite Virchow — Berlin, Germany
• Uniklinik Köln — Cologne, Germany
• Universitaetsklinikum Dusseldorf — Düsseldorf, Germany
• Universitatsklinikum Campus Kiel — Kiel, Germany
• Universitaetsklinikum Wuerzburg — Würzburg, Germany
• Osp. S. Maria Della Misericordia — Udine, Italy
• Southmead Hospital Bristol — Bristol, United Kingdom
• Charing Cross Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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