FRIDLEY (dpa-AFX) - Medical technology company Medtronic plc (MDT) announced Thursday the first enrollment in ADAPT-PD (Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease), its trial evaluating the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with Parkinson's Disease (PD).
Adaptive deep brain stimulation is an investigational feature of the Percept PC device that could be enabled if approved. The investigational feature used in this study allows for automated adjustment of brain stimulation to provide therapy to manage symptoms of Parkinson's disease based on a patient's clinical state.
The randomized study will take place across 12 study sites at leading Movement Disorders research centers in the United States, Europe, and Canada, with an estimated 36 subjects undergoing a total evaluation period of 15 months.
The primary endpoint of ADAPT-PD will compare standard continuous DBS (cDBS) to aDBS for hours of 'On' time without troublesome dyskinesias, a measure of treatment efficacy versus side effects, as reported by patient diary.
DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas of the brain as adjunctive treatment for several neurological disorders.
Medtronic DBS systems were the first approved for full-body MRI scans under specific conditions in the United States.
Copyright RTT News/dpa-AFX
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