Directional Deep Brain Stimulation Research Articles

Directional deep brain stimulation electrodes in Parkinson’s disease: meta-analysis and systematic review of the literature

BackgroundSince their introduction in 2015, directional leads have practically replaced conventional leads for deep brain stimulation (DBS) in Parkinson’s disease (PD). Yet, the benefits of directional DBS (dDBS) over omnidirectional...

Cerebral Intraparenchymal Hemorrhage due to Implantation of Electrodes for Deep Brain Stimulation: Insights from a Large Single-Center Retrospective Cross-Sectional Analysis

Cerebral intraparenchymal hemorrhage due to electrode implantation (CIPHEI) is a rare but serious complication of deep brain stimulation (DBS) surgery. This study retrospectively investigated a large single-center cohort of DBS implantations to calculate the frequency of CIPHEI and identify patient- and procedure-related risk factors for CIPHEI and their potential interactions. We analyzed all DBS implantations between January 2013 and December 2021 in a generalized linear model for binomial responses using bias reduction to account for sparse sampling of CIPHEIs. As potential risk factors, we considered age, gender, history of arterial hypertension, level of invasivity, types of micro/macroelectrodes, and implanted DBS electrodes. If available, postoperative coagulation and platelet function were exploratorily assessed in CIPHEI patients. We identified 17 CIPHEI cases across 839 electrode implantations in 435 included procedures in 418 patients (3.9%). Exploration and cross-validation analyses revealed that the three-way interaction of older age (above 60 years), high invasivity (i.e., use of combined micro/macroelectrodes), and implantation of directional DBS electrodes accounted for 82.4% of the CIPHEI cases. Acquired platelet dysfunction was present only in one CIPHEI case. The findings at our center suggested implantation of directional DBS electrodes as a new potential risk factor, while known risks of older age and high invasivity were confirmed. However, CIPHEI risk is not driven by the three factors alone but by their combined presence. The contributions of the three factors to CIPHEI are hence not independent, suggesting that potentially modifiable procedural risks should be carefully evaluated when planning DBS surgery in patients at risk.

3D-visualization of segmented contacts of directional deep brain stimulation electrodes via registration and fusion of CT and FDCT

Objectives3D-visualization of the segmented contacts of directional deep brain stimulation (DBS) electrodes is desirable since knowledge about the position of every segmented contact could shorten the timespan for electrode programming. CT cannot yield images fitting that purpose whereas highly resolved flat detector computed tomography (FDCT) can accurately image the inner structure of the electrode. This study aims to demonstrate the applicability of image fusion of highly resolved FDCT and CT to produce highly resolved images that preserve anatomical context for subsequent fusion to preoperative MRI for eventually displaying segmented contactswithin anatomical context in future studies.Material and methodsRetrospectively collected datasets from 15 patients who underwent bilateral directional DBS electrode implantation were used. Subsequently, after image analysis, a semi-automated 3D-registration of CT and highly resolved FDCT followed by image fusion was performed. The registration accuracy was assessed by computing the target registration error.ResultsOur work demonstrated the feasibility of highly resolved FDCT to visualize segmented electrode contacts in 3D. Semiautomatic image registration to CT was successfully implemented in all cases. Qualitative evaluation by two experts revealed good alignment regarding intracranial osseous structures. Additionally, the average for the mean of the target registration error over all patients, based on the assessments of two raters, was computed to be 4.16 mm.ConclusionOur work demonstrated the applicability of image fusion of highly resolved FDCT to CT for a potential workflow regarding subsequent fusion to MRI in the future to put the electrodes in an anatomical context.

Directional Deep Brain Stimulation Programming: Is the Segment Clearly Identifiable and Stable Over Time?

In our early experience programming directional deep brain stimulation (d-DBS) in PD, we found the optimal directional segment changed over time in some patients. To determine the frequency/reasons for this we examined whether (1) different programmers would identify the same segment as "optimal"; and (2) the same programmer would select the same "optimal" segment over time. We hypothesized there would be a moderately high level of agreement on optimal electrode selection between different assessors and repeated assessments by the same evaluator. This was a prospective, double-blind investigation evaluating the reliability and stability of programming d-DBS. Each patient underwent a mono-polar survey four times (2 time points by 2 separate assessors). The primary aim was the inter-rater agreement of selecting the optimal electrode at 1 and 6 months. The secondary aim was to determine the intra-rater agreement of selecting the optimal electrode from 1 to 6 months. Twenty-one patients were enrolled. There was fair inter-rater agreement at 1 month and moderate at 6 months. There was minimal intra-rater agreement between 1 and 6 months. The data refuted our hypothesis. Potential reasons for low agreement include (1) the arduous/subjective nature of identifying the optimal electrode in d-DBS systems, especially in well-placed electrodes; and/or (2) acute changes to the location of stimulation delivery offering temporary improvement in symptoms. Key takeaways gathered were it may, (1) behoove the programmer to explore different electrode montages after a period of time; and (2) be more efficient to review the directional electrode montage only when dictated by clinical symptoms/disease progression.

Somatotopy of the sensory thalamus: inputs from directional deep brain stimulation in pain patients.

The sensory ventroposterior (VP) thalamic nuclei display a mediolateral somatotopic organization (respectively head, arm, and leg). We studied this somatotopy using directional VP deep brain stimulation (DBS) in patients treated for chronic neuropathic pain. Six patients with central (four) or peripheral (two) neuropathic pain were treated by VP DBS using directional leads in a prospective study (clinicaltrials.gov NCT03399942). Lead-DBS toolbox was used for leads localization, visualization, and modeling of the volume of tissue activated (VTA). Stimulation was delivered in each direction, 1 month after surgery and correlated to the location of stimulation-induced paresthesias. The somatotopy was modeled by correlating the respective locations of paresthesias and VTAs. We recorded 48 distinct paresthesia maps corresponding to 48 VTAs (including 36 related to directional stimulation). We observed that, in each patient, respective body representations of the trunk, upper limb, lower limb, and head were closely located around the lead. These representations differed across patients, did not follow a common organization and were not concordant with the previously described somatotopic organization of the sensory thalamus. Thalamic reorganization has been reported in chronic pain patients compared to non-pain patients operated for movement disorders in previous studies using intraoperative recordings and micro-stimulation. Using a different methodology, namely 3D representation of the VTA by the directional postoperative stimulation through a stationary electrode, our study brings additional arguments in favor of a reorganization of the VP thalamic somatotopy in patients suffering from chronic neuropathic pain of central or peripheral origin.

1137 Prospective, Multicenter, International Registry of Deep Brain Stimulation for Dystonia: A Sub-analysis of Cervical Dystonia Patients

INTRODUCTION: Management of dystonia using Deep Brain Stimulation (DBS) is a well-established therapeutic approach. However, optimal DBS target sites in patients with cervical (focal) versus generalized dystonia are thought to diverge and be specific for particular connections (Horn 2022). DBS devices equipped with capabilities such as directionality and Multiple Independent Current Control (MICC) may offer potential for improved clinical outcomes. METHODS: This is a sub-analysis of patients with focal (cervical) dystonia only or cervical dystonia in the context of segmental or generalized dystonia assessed as part of a prospective, multicenter, international dystonia registry (NCT02686125). All patients receive an MICC-based, directional DBS system (Vercise, Boston Scientific). Patients are followed up to 3-years (post-implant). Several study assessments are being collected to evaluate their dystonia symptoms (e.g., TWSTRS), quality of life, and overall satisfaction. Adverse Events are also collected. RESULTS: A total of 43-patients (mean age 56.9-years, 58% females) with focal (cervical) dystonia only and 83 patients (mean 41.95-years, 61% females) with cervical dystonia in context of segmental or generalized dystonia have been evaluated. Both groups reported significant improvement in overall TWSTRS scores – however the extent varied. In the cervical-only cohort, a 19.9-point improvement was noted at 6-months (n = 25) and sustained up to 1-year (23.2-point improvement, n = 20). In those with cervical dystonia within frame of segmental or generalized dystonia, a 9.7-point and 7.3-point improvement in overall TWSTRS scores was noted at 6- (n = 50) and 12-months (n = 38), respectively. Updated data will be reported. CONCLUSIONS: This registry represents the first comprehensive, large-scale collection of real-world outcomes associated with dystonia patients implanted with a directional DBS system capable of MICC. Preliminary results demonstrate significant improvement in patients with cervical dystonia (alone or in context of segmental or generalized dystonia) following DBS.

Directional deep brain stimulation in the management of Parkinson's disease: efficacy and constraints-an analytical appraisal.

Deep brain stimulation (DBS) is a widely employed treatment for Parkinson's disease. However, conventional DBS utilizing ring-shaped leads can often result in undesirable side effects by stimulating nearby brain structures, thus limiting its effectiveness. To address this issue, a novel DBS electrode was developed to allow for directional stimulation, avoiding neighboring structures. This literature review aims to analyze the disparities between conventional and directional DBS and discuss the benefits and limitations associated with this innovative electrode design, focusing on the stimulation-induced side effects it can or cannot mitigate. A comprehensive search was conducted in MEDLINE/PubMed, ScienceDirect, and EBSCO databases using the Boolean search criteria: "Deep brain stimulation" AND "Parkinson" AND "Directional." Following the application of inclusion and exclusion criteria, the selected articles were downloaded for full-text reading. Subsequently, the results were organized and analyzed to compose this article. Numerous studies have demonstrated that directional DBS effectively reduces side effects associated with brain stimulation, prevents the stimulation of non-targeted structures, and expands the therapeutic window, among other advantages. However, it has been observed that directional DBS may be more challenging to program and requires higher energy consumption. Furthermore, there is a lack of standardization among different manufacturers of directional DBS electrodes. Various stimulation-induced side effects, including dysarthria, dyskinesia, paresthesias, and symptoms of pyramidal tract activation, have been shown to be mitigated with the use of directional DBS. Moreover, directional electrodes offer a wider therapeutic window and a reduced incidence of undesired effects, requiring the same or lower minimum current for symptom relief compared to conventional DBS. The utilization of directional leads in DBS offers numerous advantages over conventional electrodes without significant drawbacks for patients undergoing directional DBS therapy.

Seeing Is Believing: Photon Counting Computed Tomography Clearly Images Directional Deep Brain Stimulation Lead Segments and Markers After Implantation

Background and ObjectivesDirectional deep brain stimulation (DBS) electrodes are increasingly used, but conventional computed tomography (CT) is unable to directly image segmented contacts owing to physics-based resolution constraints. Postoperative electrode segment orientation assessment is necessary because of the possibility of significant deviation during or immediately after insertion. Photon-counting detector (PCD) CT is a relatively novel technology that enables high resolution imaging while addressing several limitations intrinsic to CT. We show how PCD CT can enable clear in vivo imaging of DBS electrodes, including segmented contacts and markers for all major lead manufacturers. Materials and MethodsWe describe postoperative imaging and reconstruction protocols we have developed to enable optimal lead visualization. PCD CT images were obtained of directional leads from the three major manufacturers and fused with preoperative 3T magnetic resonance imaging (MRI). Radiation dosimetry also was evaluated and compared with conventional imaging controls. Orientation estimates from directly imaged leads were compared with validated software-based reconstructions (derived from standard CT imaging artifact analysis) to quantify congruence in alignment and directional orientation. ResultsHigh-fidelity images were obtained for 15 patients, clearly indicating the segmented contacts and directional markers both on CT alone and when fused to MRI. Our routine imaging protocol is described. Ionizing radiation doses were significantly lower than with conventional CT. For most leads, the directly imaged lead orientations and depths corresponded closely to those predicted by CT artifact-based reconstructions. However, unlike direct imaging, the software reconstructions were susceptible to 180° error in orientation assessment. ConclusionsHigh-resolution photon-counting CT can very clearly image segmented DBS electrode contacts and directional markers and unambiguously determine lead orientation, with lower radiation than in conventional imaging. This obviates the need for further imaging and may facilitate anatomically tailored directional programming.

Directional versus ring-mode deep brain stimulation for Parkinson’s disease: protocol of a multi-centre double-blind randomised crossover trial

BackgroundThe effectiveness of Deep Brain Stimulation (DBS) therapy for Parkinson’s disease can be limited by side-effects caused by electrical current spillover into structures adjacent to the target area. The objective of the STEEred versus RING-mode DBS for Parkinson’s disease (STEERING) study is to investigate if directional DBS for Parkinson’s disease results in a better clinical outcome when compared to ring-mode DBS.MethodsThe STEERING study is a prospective multi-centre double-blind randomised crossover trial. Inclusion criteria are Parkinson’s disease, subthalamic nucleus DBS in a ‘classic’ ring-mode setting for a minimum of six months, and optimal ring-mode settings have been established. Participants are categorised into one of two subgroups according to their clinical response to the ring-mode settings as ‘responders’ (i.e., patient with a satisfactory effect of ring-mode DBS) or ‘non-responder’ (i.e., patient with a non-satisfactory effect of ring-mode DBS). A total of 64 responders and 38 non-responders will be included (total 102 patients). After an optimisation period in which an optimal directional setting is found, participants are randomised to first receive ring-mode DBS for 56 days (range 28–66) followed by directional DBS for 56 days (28–66) or vice-versa. The primary outcome is the difference between ring-mode DBS and directional DBS settings on the Movement Disorders Society Unified Parkinson’s Disease Rating Scale – Motor Evaluation (MDS-UPDRS-ME) in the off-medication state. Secondary outcome measures consist of MDS-UPDRS-ME in the on-medication state, MDS-UPDRS Activities of Daily Living, MDS-UPDRS Motor Complications–Dyskinesia, disease related quality of life measured with the Parkinson’s Disease Questionnaire 39, stimulation-induced side-effects, antiparkinsonian medication use, and DBS-parameters. Participants’ therapy preference is measured at the end of the study. Outcomes will be analysed for both responder and non-responder groups, as well as for both groups pooled together.DiscussionThe STEERING trial will provide insights into whether or not directional DBS should be standardly used in all Parkinson’s disease DBS patients or if directional DBS should only be used in a case-based approach.Trial registrationThis trial was registered on the Netherlands Trial Register, as trial NL6508 (NTR6696) on June 23, 2017.

Local Field Potentials Predict Motor Performance in Deep Brain Stimulation for Parkinson's Disease.

Deep brain stimulation (DBS) is an effective treatment option for patients with Parkinson's disease (PD). However, clinical programming remains challenging with segmented electrodes. Using novel sensing-enabled neurostimulators, we investigated local field potentials (LFPs) and their modulation by DBS to assess whether electrophysiological biomarkers may facilitate clinical programming in chronically implanted patients. Sixteen patients (31 hemispheres) with PD implanted with segmented electrodes in the subthalamic nucleus and a sensing-enabled neurostimulator were included in this study. Recordings were conducted 3 months after DBS surgery following overnight withdrawal of dopaminergic medication. LFPs were acquired while stimulation was turned OFF and during a monopolar review of both directional and ring contacts. Directional beta power and stimulation-induced beta power suppression were computed. Motor performance, as assessed by a pronation-supination task, clinical programming and electrode placement were correlated to directional beta power and stimulation-induced beta power suppression. Better motor performance was associated with stronger beta power suppression at higher stimulation amplitudes. Across directional contacts, differences in directional beta power and the extent of stimulation-induced beta power suppression predicted motor performance. However, within individual hemispheres, beta power suppression was superior to directional beta power in selecting the contact with the best motor performance. Contacts clinically activated for chronic stimulation were associated with stronger beta power suppression than non-activated contacts. Our results suggest that stimulation-induced β power suppression is superior to directional β power in selecting the clinically most effective contact. In sum, electrophysiological biomarkers may guide programming of directional DBS systems in PD patients. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Variations in Determining Actual Orientations of Segmented Deep Brain Stimulation Leads Using the DiODe Algorithm: A Retrospective Study Across Different Lead Designs and Medical Institutions

Introduction: Directional deep brain stimulation (DBS) leads have become widely used in the past decade. Understanding the asymmetric stimulation provided by directional leads requires precise knowledge of the exact orientation of the lead in respect to its anatomical target. Recently, the DiODe algorithm was developed to automatically determine the orientation angle of leads from the artifact on postoperative computed tomography (CT) images. However, manual DiODe results are user-dependent. This study analyzed the extent of lead rotation as well as the user agreement of DiODe calculations across the two most common DBS systems, namely, Boston Scientific’s Vercise and Abbott’s Infinity, and two independent medical institutions. Methods: Data from 104 patients who underwent an anterior-facing unilateral/bilateral directional DBS implantation at either Northwestern Memorial Hospital (NMH) or Albany Medical Center (AMC) were retrospectively analyzed. Actual orientations of the implanted leads were independently calculated by three individual users using the DiODe algorithm in Lead-DBS and patients’ postoperative CT images. The deviation from the intended orientation and user agreement were assessed. Results: All leads significantly deviated from the intended 0° orientation (p < 0.001), regardless of DBS lead design (p < 0.05) or institution (p < 0.05). However, the Boston Scientific leads showed an implantation bias toward the left at both institutions (p = 0.014 at NMH, p = 0.029 at AMC). A difference of 10° between at least two users occurred in 28% (NMH) and 39% (AMC) of all Boston Scientific and 76% (NMH) and 53% (AMC) of all Abbott leads. Conclusion: Our results show that there is a significant lead rotation from the intended surgical orientation across both DBS systems and both medical institutions; however, a bias toward a single direction was only seen in the Boston Scientific leads. Additionally, these results raise questions into the user error that occurs when manually refining the orientation angles calculated with DiODe.

Racial disparities in access to DBS: results of a real-world U.S. claims data analysis.

Deep brain stimulation (DBS) is an effective and standard-of-care therapy for Parkinson's Disease and other movement disorders when symptoms are inadequately controlled with conventional medications. It requires expert care for patient selection, surgical targeting, and therapy titration. Despite the known benefits, racial/ethnic disparities in access have been reported. Technological advancements with smartphone-enabled devices may influence racial disparities. Real-world evidence investigations can shed further light on barriers to access and demographic disparities for DBS patients. A retrospective cross-sectional study was performed using Medicare claims linked with manufacturer patient data tracking to analyze 3,869 patients who received DBS. Patients were divided into two categories: traditional omnidirectional DBS systems with dedicated proprietary controllers ("traditional"; n = 3,256) and directional DBS systems with smart controllers ("smartphone-enabled"; n = 613). Demographics including age, sex, and self-identified race/ethnicity were compared. Categorical demographics, including race/ethnicity and distance from implanting facility, were analyzed for the entire population. A significant disparity in DBS utilization was evident. White individuals comprised 91.4 and 89.9% of traditional and smartphone-enabled DBS groups, respectively. Non-White patients were significantly more likely to live closer to implanting facilities compared with White patients. There is great racial disparity in utilization of DBS therapy. Smartphone-enabled systems did not significantly impact racial disparities in receiving DBS. Minoritized patients were more likely to live closer to their implanting facility than White patients. Further research is warranted to identify barriers to access for minoritized patients to receive DBS. Technological advancements should consider the racial discrepancy of DBS utilization in future developments.

ID: 197975 Real-World Outcomes Using DBS Systems With Directionality and Multiple Independent Current Control: USA Experience

Deep Brain Stimulation (DBS) is an effective strategy in reducing the motor complications in Parkinson's disease (PD) as substantiated by several randomized controlled trials.1-4 This motor improvement has shown to be sustained for up to 10 years.5 Real-world data collected from a wide variety of implanting centers based on standard of care documenting overall improvements in PD disease symptoms, quality of life may facilitate new insights regarding the real-world, clinical use and outcomes of DBS. We present preliminary outcomes from an ongoing prospective, on-label, multicenter outcomes study conducted in the United States of patients with directional Deep Brain Stimulation (DBS) Systems capable of multiple independent current control (MICC) for management of the motor symptoms of levodopa- responsive Parkinson's disease (PD).

ID: 197424 Improvement in Quality-of-Life and Motor Function: Real-World, Prospective Study of Directional DBS Systems

Early Deep Brain Stimulation (DBS) systems used ring-shaped electrodes to achieve axial selectivity in stimulation of target tissue. However, directional current steering allows for rotational selectivity (in addition to axial) and has the potential to further improve patient outcomes by avoiding off-target stimulation due to the ability to create a well-defined field around the intended target. Several pilot studies have corroborated the use of directionality and its impact on therapeutic window and adverse effects.1-3 In this report, real-world outcomes using Directional DBS Systems with multiple independent current source control (MIC() for use in managing symptoms of levodopa responsive Parkinson's disease (PD) are reported.

ID: 197707 Quality-of-Life Improvement and Patient's Impression of Change With Use of Directional DBS Therapy for PD

Deep Brain Stimulation (DBS) is an established treatment for motor signs and fluctuations associated with Parkinson's disease (PD). Retrospective studies can provide a relatively quick and cost-effective means to obtain data regarding various types of patient outcomes when devices are being used per standard-of-care in the real world clinical setting, thereby contributing to real-world evidence (RWE). Here, we report clinical outcomes associated with the use of DBS systems capable of directionality and Multiple Independent Current Control (MICC) used in the management of PD motor symptoms.

A Novel and Simple Method Using Computed Tomography Streak Artifact to Determine the Orientation of Directional Deep Brain Stimulation Leads.

Directional leads have garnered widespread use in deep brain stimulation (DBS) because of the ability to steer current and maximize the therapeutic window. Accurate identification of lead orientation is critical to effective programming. Although directional markers are visible on 2-dimensional imaging, precise orientation may be difficult to interpret. Recent studies have suggested methods of determining lead orientation, but these involve advanced intraoperative imaging and/or complex computational algorithms. Our objective is to develop a precise and reliable method of determining orientation of directional leads using conventional imaging techniques and readily available software. We examined postoperative thin-cut computed tomography (CT) scans and x-rays of patients who underwent DBS with directional leads from 3 vendors. Using commercially available stereotactic software, we localized the leads and planned new trajectories precisely overlaying the leads visualized on CT. We used trajectory view to locate the directional marker in a plane orthogonal to the lead and inspected the streak artifact. We then validated this method with a phantom CT model by acquiring thin-cut CT images orthogonal to 3 different leads in various orientations confirmed under direct visualization. The directional marker creates a unique streak artifact that reflects the orientation of the directional lead. There is a hyperdense symmetric streak artifact parallel to the axis of the directional marker and a symmetric hypodense dark band orthogonal to the marker. This is often sufficient to infer the direction of the marker. If not, it at least renders 2 opposite possibilities for the direction of the marker, which can then be easily reconciled by comparison with x-ray images. We propose a method to determine orientation of directional DBS leads in a precise manner on conventional imaging and readily available software. This method is reliable across DBS vendors, and it can simplify this process and aid in effective programming.

Real-World Outcomes in USA using DBS Systems with Directionality and Multiple Independent Current Control (P5-11.017)

Real-World Outcomes in USA using DBS Systems with Directionality and Multiple Independent Current Control (P5-11.017)

Therapeutic Outcomes of Directional Deep Brain Stimulation in Essential Tremor Patients (P7-11.007)

<h3>Objective:</h3> Analyzing directional deep brain stimulation (DBS) outcomes in Essential Tremor (ET) patients using the Abbott Infinity and Boston Scientific Vercise Systems. <h3>Background:</h3> Stimulation of the Ventralis Intermedius nucleus of the thalamus (VIM) effectively suppresses tremors in patients with ET. Data on the long-lasting benefits of directional current delivery remains limited. <h3>Design/Methods:</h3> Tremor was evaluated in 9 ET patients implanted with directional DBS leads using the Fahn-Tolosa-Marin Tremor Scale (FTM). One patient was subsequently diagnosed with parkinsonism. In our sample 7 patients were implanted bilaterally and 2 unilaterally, 7 implanted with Abbott Infinity and 2 with the Boston Scientific Vercise system. FTM assessments were obtained preoperatively and 7 to 16 months following device activation. <h3>Results:</h3> On average patients exhibited tremors for 23.3 ±17.9 years. Mean age at surgery was 67.2 ±11.0 years. Preoperatively FTM scores ranged from 36 to 88 points with a mean of 51.3 ±15.9, while 11.6 ±2.9 months post device activation FTM scores ON stimulation ranged 7 to 31 points and averaged 15.9±8.2. FTM scores ON stimulation at postoperative follow-up decreased by 66% when compared with FTM scores at baseline. Medication reduction or discontinuation was observed in 71% of patients who were prescribed tremor suppressing medications at baseline. Segmented DBS contacts were used in 15 of the 16 directional leads. <h3>Conclusions:</h3> Tremor control using directional DBS leads in ET patients is evident by reduction in FTM scores approximately 1 year following DBS activation, especially in the setting of medication reduction. Future analysis of clinical outcomes in a larger cohort and investigation of directional DBS lead parameters is necessary to thoroughly understand and optimize directional current stimulation. <b>Disclosure:</b> The institution of Ms. Shub has received research support from Abbott and Boston Scientific . Dr. Smith has nothing to disclose. Dr. Zesiewicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Uniqure. Dr. Zesiewicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Retrotope. Dr. Zesiewicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Reata. Dr. Zesiewicz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Zesiewicz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Steniment. Dr. Zesiewicz has received intellectual property interests from a discovery or technology relating to health care. Teresita Malapira has nothing to disclose. Yarema B Bezchlibnyk has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for PMT Corporation. Yarema B Bezchlibnyk has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Yarema B Bezchlibnyk has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Yarema B Bezchlibnyk has received personal compensation in the range of $0-$499 for serving as a Consultant for Medtronic.

Improvement in Quality of Life and Motor Function during Daily Clinical Practice using Directional DBS Systems (P4-11.010)

<h3>Objective:</h3> To understand the benefits of Deep Brain Stimulation (DBS) systems with Multiple Independent Current Control (MICC) in daily clinical practice in patients with Parkinson’s disease (PD). <h3>Background:</h3> The main goal of DBS therapy is to achieve optimal outcomes while avoiding side effects. The challenging anatomy surrounding DBS targets requires precise control of neurostimulation. Directional DBS systems can deliver specific amounts of current to each contact using MICC, and this capability has been shown to increase therapeutic window under controlled study conditions (Dembek 2017; Schnitzler 2022). In so doing, vertical and horizontal steering of cathodic and/or anodic current can be achieved, thereby providing flexible programming options to deliver stimulation while minimizing side effects (Steigerwald 2016) (Kirsch 2018). <h3>Design/Methods:</h3> This is a prospective, multicenter (International), registry of up to 1500-patients implanted with directional MICC-based DBS systems (Vercise, Boston Scientific), per standard-of-care. Participants are being followed up to 3-years post-implantation whereby quality-of-life, motor symptoms improvement, overall satisfaction, and other disease aspects are measured. Adverse events and device-related complications are collected. <h3>Results:</h3> A total of 815-patients have been evaluated. Quality-of-life as assessed by PDQ-39 out to 2-years demonstrated sustained clinically significant improvement (minimal clinically important difference [MCID] &gt;4.7-points) despite an expected 5-point worsening due to disease progression (p&lt;0.001) (Horvath 2017; Reuther 2007). Improvement in motor function (MDS-UPDRS III Meds-OFF ) versus baseline were also noted (35% reduction at 2-year; p&lt;0.0001). To date, with &gt;1500 directional leads implanted, no lead breakages have been reported. <h3>Conclusions:</h3> This on-going registry represents the first large-scale collection of real-world, long-term outcomes using MICC-based directional DBS systems. Use of directional DBS systems in clinical practice has been demonstrated to be beneficial per increases in therapeutic window and associated positive outcomes. Results from this on-going evaluation demonstrate sustained improvement in overall outcomes with the use of directional DBS systems. <b>Disclosure:</b> Dr. Deuschl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific Cavion Functional Neuromodulation. The institution of Dr. Deuschl has received research support from Medtronic. Dr. Deuschl has received publishing royalties from a publication relating to health care. Roshini Jain has received personal compensation for serving as an employee of Boston Scientific. Roshini Jain has received stock or an ownership interest from Boston Scientific. Heleen Scholtes has received personal compensation for serving as an employee of Boston Scientific. Lilly Chen has received personal compensation for serving as an employee of Boston Scientific . Michael Barbe, MD has nothing to disclose. Steffen Paschen has nothing to disclose. Andrea Kuehn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Andrea Kuehn has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific. Dr. Lee has nothing to disclose. Jan Vesper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boston Scientific . Jan Vesper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medtronic . Jan Vesper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbott . Jan Vesper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbott . Jan Vesper has received research support from German Research Council.

Tremor Reduction using DBS: Outcomes of a Real-world, Prospective, Multicenter Essential Tremor Registry (P7-11.004)

<h3>Objective:</h3> To evaluate outcomes of directional DBS systems with Multiple Independent Current Control (MICC) technology when implanted in patients with Essential Tremor (ET) as standard of care. <h3>Background:</h3> ET is one of the most common neurological diseases affecting about 0.9% of the world population. Medical treatment is focused on management of motor symptoms, and therapeutic options include pharmacotherapy, ventral intermediate nucleus (Vim) thalamotomy, and/or thalamic Deep Brain Stimulation (DBS). Currently, Vim DBS is recommended as a therapeutic option for appropriate subjects with ET (Wharen 2017, Zesiewicz 2005). <h3>Design/Methods:</h3> In this prospective, on-label, multi-center, international DBS registry, enrolled patients are implanted with a directional MICC-based DBS system (Vercise, Boston Scientific). Patients are followed up to 3-years where overall improvement in quality of life and ET symptoms are evaluated. Adverse events are also being collected. <h3>Results:</h3> To date, 30-patients have been implanted (age = 64.8 ± 15.1 years [Mean (SD)], 53.1% male) with a mean disease duration of 19.3-years. A 17.3-point change in QUEST Summary Index was noted at 12-months representing a clinically significant difference (&gt;4.47-point change) (Pinter 2019). In addition, a mean 9-hours of tremor reduction in a typical day was noted (14.7-hours at Baseline versus 6.5-hours at 12-months). Moreover, based on the severity scale of FTMTRS, when comparing disability at 12-months (vs Baseline), no patient reported experiencing marked disability (vs. 9.4% at Baseline), 16.7% reported moderate disability (vs. 81.3% at Baseline) and 83.3% reported mild disability (vs 9.4% at Baseline). <h3>Conclusions:</h3> Preliminary results from this ongoing registry show clinically important outcomes in quality of life, as well as motor function, thereby reflecting improvement in overall disability among patients (i.e., a disability profile moving from moderate/severe to more mild/moderate disability). This registry represents the first comprehensive, large-scale collection of real-world outcomes with MICC-based DBS systems for ET. <b>Disclosure:</b> Dr. Deuschl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific Cavion Functional Neuromodulation. The institution of Dr. Deuschl has received research support from Medtronic. Dr. Deuschl has received publishing royalties from a publication relating to health care. Dr. Loret has nothing to disclose. The institution of Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. The institution of Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. The institution of Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for boston Scientific. Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Hungarian Scientific Parkinson’s Disease Society. The institution of Norbert Kovacs has received research support from Abbott. The institution of Norbert Kovacs has received research support from Hungarian National Research Board. Dr. Clement has nothing to disclose. P.R. Schuurman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Boston Scientific. P.R. Schuurman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic.