Objective: To evaluate neuropsychological outcomes in subjects participating in the INTREPID randomized controlled trial (RCT).

Background: Neuropsychological evaluation in the context of Deep Brain Stimulation (DBS) for Parkinson’s disease (PD) is important for the following: a) pre-operative screening and b) assessment of the potential effect of DBS on cognitive and emotional symptoms. The INTREPID RCT sought to evaluate the improvement in motor function and quality of life in patients with advanced, levodopa-responsive PD following bilateral subthalamic nucleus (STN) DBS using a new device equipped with multiple current sources. In this report, neuropsychological outcomes from subjects participating in the INTREPID RCT will be specifically described. These outcomes are of particular interest and novel because the multiple current source device offers the potential for current steering and shaping.

Method: INTREPID (ClinicalTrials.gov Identifier: NCT01839396) is a multi-center, prospective, double-blind,randomized controlled trial (RCT) sponsored by Boston Scientific. Subjects with advanced PD were implanted bilaterally in the STN with a multiple-source, constant current DBS System (Vercise, Boston Scientific). Subjects were evaluated by a neuropsychologist before and after implantation in the meds on condition. A battery of neuropsychological assessments were collected, specifically the following: Mattis Dementia Rating Scale (DRS-2) Starkstein Apathy Scale (SAS), Beck Depression Inventory (BDI-II, and the Columbia Suicide Severity Scale (CSSRS).

Results: Data collection and analysis is currently still ongoing. Analyzed results derived from neuropsychological assessments are to be presented.

Conclusion: Studies of neuropsychological outcomes of STN-DBS generally support the safety of the procedure from a neuropsychological standpoint, though a minority of patients experience cognitive or emotional adverse events within 6 months of surgery and verbal fluency declines are common. The INTREPID trial provides an opportunity to enhance the existing literature by reporting neuropsychological DBS outcomes using a multiple current source device.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/assessment-of-neuropsychological-outcomes-using-a-new-multiple-source-constant-current-rechargeable-deep-brain-stimulation-system-for-the-treatment-of-parkinsons-disease-intrepid-study/