CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/14/2017 |
Start Date: | June 2013 |
End Date: | December 2014 |
Current Steering to Optimize Deep Brain Stimulation
The objective of the study is to compare different deep brain stimulation (DBS) settings
using the commercially approved Boston Scientific Neuromodulation Vercise system.
using the commercially approved Boston Scientific Neuromodulation Vercise system.
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.
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.
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.
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2
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