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The purpose of this study is to use local field potentials as control signals for adjusting DBS stimulation settings under varying patient states and to assess patient outcomes.
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Inclusion and exclusion criteria
Inclusion Criteria:
Preoperative:
Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted
Subject with levodopa-responsive PD of at least 4 years' duration, with symptoms not adequately controlled with medication, including individuals with motor complications of recent onset (from 4 months to 3 years) or with motor complications of longer-standing duration, and who are eligible for bilateral STN DBS surgery
Subject is ≥ 22 years of age at time of informed consent
Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
Subject has documented improvement in motor signs ON versus OFF dopaminergic medication, with a change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III score of > 30% OFF to ON medication
Based on the opinion of the Neurosurgeon, the subject is an acceptable candidate for implant of a DBS System that includes: bilateral DBS leads targeted to the STN, extensions, and neurostimulator
Subject can read and understand English
Subject is willing and able to attend all study-required visits and complete the study procedures
Subject is willing and able to be awake during left and right DBS lead implant surgery and for intraoperative LFP recordings
Intraoperative:
Required beta band (13 - 30 Hz) signal detected on left and right DBS leads
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
1 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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