2023 American Academy of Neurology Abstract Website

Michael Okun¹, Kelly Foote², Theresa Zesiewicz³, Yarema Bezchlibnyk³, Alexander Papanastassiou⁴, Jonathan Carlson⁵, Jason Aldred⁶, Vibhor Krishna⁷, Aristide Merola⁸, Corneliu Luca⁹, Jonathan Jagid⁹, Jennifer Durphy¹⁰, Leonard Verhagen Metman¹¹, Sepehr Sani¹², Steven Ojemann¹³, Drew Kern¹⁴, David Weintraub¹⁵, Ritesh Ramdhani¹⁵, Abdolreza Siadati¹⁶, Bharathy Sundaram¹⁷, Cong Zhi Zhao¹⁸, Derek Martinez¹⁹, Mustafa Siddiqui²⁰, Stephen Tatter²¹, Lilly Chen²², Roshini Jain²³
¹University of Florida, ²University of Florida – Normal Fixel Institute for Neurological Diseases, ³University of South Florida, ⁴University of Texas, San Antonio, ⁵Inland Neurosurgery and Spine, ⁶Selkirk Neurology, ⁷Ohio State University, ⁸University of Cincinnati, ⁹University of Miami, ¹⁰Albany Medical Center, ¹¹Northwestern University Medical Center, ¹²Rush University Medical Center, ¹³University of Colorado Anschutz Medical Campus, ¹⁴University of Colorado, ¹⁵Northwell Health, ¹⁶Texas Institute for Neurological Disorders, ¹⁷Texas Institute for Neurological DIsorders, ¹⁸St. Luke's Neurology, ¹⁹St. Luke's Regional Medical Center, ²⁰Wake Forest University, ²¹Wake Forest Univ School of Medicine, ²²Boston Scientific, ²³Boston Scientific Neuromodulation

Objective:

To characterize real-world data (USA experience) with the use of directional Deep Brain Stimulation (DBS) systems with multiple-independent current control (MICC) in the treatment of Parkinson’s Disease (PD).

Background:

Randomized controlled trials have demonstrated that DBS can be an effective strategy for reducing the motor complications in PD (Okun 2012, Schuepbach, 2013, Vitek 2020) with potential for sustained improvement greater than 10-years (Deuschl 2013). However, large, multi-center, real-world data can reveal insights in the care of PD patients when DBS is used per standard-of-care.

Design/Methods:

Prospectively enrolled participants are implanted with Vercise DBS systems (Boston Scientific), a multiple-source, constant-current system, and are assessed up to 3-years post-implantation. Clinical measures recorded at baseline and during study follow-up include MDS-Unified Parkinson's disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire (PDQ-39), Global Impression of Change (GIC) , and Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications are also collected.

Results:

A total of 106-patients (mean age: 63.8 ± 8.7 years, 73% male, disease duration 9.9-years) have been enrolled, and 82 have had their device activated. At 6-months (n = 56), an 8.3-point improvement in PDQ-39 Summary Index (27.1 à 18.8, p<0.0001) was noted, thereby representing a clinically significant improvement in quality of life (MCID >4.7-points) (Horvath 2017). According to GIC, all patients (100%) and 95% of clinicians reported improvement at 6-months. No lead breakage or unanticipated adverse events reported.

Conclusions:

Real-world outcomes from this large, prospective, multi-center outcomes study demonstrate improvement in quality of life following DBS, and a high global impression of improvement among patients and clinicians. Data from this study will continue to provide insight regarding the application of the MICC-based directional DBS Systems for PD in clinical practice.