Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study

Vitek, Jerrold L.; Jain, Roshini; Chen, Lung Chi; Tröster, Alexander I.; Schrock, Lauren E.; House, Paul; Giroux, Monique; Hebb, Adam O.; Farris, Sierra; Whiting, Donald; Leichliter, Timothy; Ostrem, Jill L.; Luciano, Marta San; Galifianakis, Nicholas B.; Metman, Leo Verhagen; Sani, Sepehr; Karl, Jessica A.; Siddiqui, Mustafa S.; Tatter, Stephen B.; Haq, Ihtsham; Machado, André G.; Gostkowski, Michal; Tagliati, Michele; Mamelak, Adam N.; Okun, Michael S.; Foote, Kelly D.; Moguel‐Cobos, Guillermo; Ponce, Francisco A.; Pahwa, Rajesh; Nazzaro, Jules M.; Buetefisch, Cathrin M.; Gross, Robert E.; Luca, Corneliu; Jagid, Jonathan; Revuelta, Gonzalo J.; Takács, István; Pourfar, Michael; Mogilner, Alon Y.; Duker, Andrew P.; Mandybur, George T.; Rosenow, Joshua M.; Cooper, Scott E.; Park, Michael C.; Khandhar, Suketu M.; Sedrak, Mark; Phibbs, Fenna T.; Pilitsis, Julie G.; Uitti, Ryan J.; Starr, Philip A.

doi:10.1016/s1474-4422(20)30108-3

Cited by 93 publications

(82 citation statements)

References 23 publications

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“…(1) there exist meaningful inter-individual anatomic variability of subcortical structures (Duchin et al, 2018;Plantinga et al, 2018), (2) imaging tools, until recently, have had limited ability to detect these differences, and (3) the STN functional territories include zones of considerable overlap (Haynes and Haber, 2013;Plantinga et al, 2018), then not only is the unresolved controversy over DBS lead location understandable, but we can also provide one additional explanation for why there has been such remarkably high variability of DBS outcomes within and across studies (Deuschl et al, 2006;Follett et al, 2010;Vitek et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

“…Still others have argued that the best location includes a region just dorsal to the STN (Plaha et al, 2006;Kasasbeh et al, 2013). These discrepancies likely contribute to the significant variability of clinical outcomes observed in clinical trials and day-to-day DBS therapy across centers (Deuschl et al, 2006;Follett et al, 2010;Vitek et al, 2020) as well as the unexpectedly high rate of documented DBS lead revisions (Rolston et al, 2016). Possible causes for these discrepancies and clinical observations include targeting preferences, image quality and the use of brain atlases that do not account for patient-specific anatomic variability.…”

Section: Introductionmentioning

confidence: 99%

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7T MRI and Computational Modeling Supports a Critical Role of Lead Location in Determining Outcomes for Deep Brain Stimulation: A Case Report

Schrock

Patriat

Goftari

et al. 2021

Front. Hum. Neurosci.

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Subthalamic nucleus (STN) deep brain stimulation (DBS) is an established therapy for Parkinson’s disease motor symptoms. The ideal site for implantation within STN, however, remains controversial. While many argue that placement of a DBS lead within the sensorimotor territory of the STN yields better motor outcomes, others report similar effects with leads placed in the associative or motor territory of the STN, while still others assert that placing a DBS lead “anywhere within a 6-mm-diameter cylinder centered at the presumed middle of the STN (based on stereotactic atlas coordinates) produces similar clinical efficacy.” These discrepancies likely result from methodological differences including targeting preferences, imaging acquisition and the use of brain atlases that do not account for patient-specific anatomic variability. We present a first-in-kind within-patient demonstration of severe mood side effects and minimal motor improvement in a Parkinson’s disease patient following placement of a DBS lead in the limbic/associative territory of the STN who experienced marked improvement in motor benefit and resolution of mood side effects following repositioning the lead within the STN sensorimotor territory. 7 Tesla (7 T) magnetic resonance imaging (MRI) data were used to generate a patient-specific anatomical model of the STN with parcellation into distinct functional territories and computational modeling to assess the relative degree of activation of motor, associative and limbic territories.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

7T MRI and Computational Modeling Supports a Critical Role of Lead Location in Determining Outcomes for Deep Brain Stimulation: A Case Report

Schrock

Patriat

Goftari

et al. 2021

Front. Hum. Neurosci.

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“…We found no negative impact of lead rotation (irrespectively of its extent) on clinical outcomes in PD. This has not been demonstrated before but it does not come as a big surprise given the fact that directional leads have proven their clinical efficacy in PD [12]. Clinical approaches to programming like monopolar reviews [4] simply identify the most effective contacts and are therefore not depending on knowledge of rotation angles.…”

Section: Discussionmentioning

confidence: 99%

Longitudinal Assessment of Rotation Angles after Implantation of Directional Deep Brain Stimulation Leads

Lange¹,

Steigerwald²,

Engel³

et al. 2020

Stereotact Funct Neurosurg

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Purpose: The risk/benefit-ratio of deep brain stimulation (DBS) depends on focusing the electrical field onto the target volume, excluding side-effect eliciting structures. Directional leads limiting radial current diffusion can target stimulation but add a spatial degree of freedom that requires control to align multimodal imaging datasets and for anatomical interpretation of stimulation. Unpredictable postoperative lead rotations have been reported. The extent and timing of rotation from the surgically intended alignment remain uncertain, as does the time point at which directional stimulation can be safely initiated without risking unexpected shifts in stimulation volume. We present a retrospective analysis of clinically indicated, repeated neuroimaging controls postimplantation in patients with directional DBS systems, which allow estimation of the amount and timing of postoperative lead rotation. Methods: Data from 67 patients with directional leads and multiple cranial computer tomographies (CCT) and/or rotation fluoroscopies at different postoperative time points were included. Rotation angles were detected based on CCT artifacts (n = 56) or direct visualization of lead segments on rotation fluoroscopies (n = 52). Cross-validation of both methods was conducted in patients who received both imaging modalities (n = 51). Results: Rotation angles deviated significantly (∼30°) from their intended 0° anterior/posterior orientation. Rotation was firmly established within the first postoperative day, with no additional torque in subsequent scans. The two methods highly correlated (right hemisphere: R2 = 0.94, left hemisphere: R2 = 0.91). Conclusion: Both methods for measuring rotation angles led to comparable results and can be used interchangeably. Directional stimulation settings can safely be initiated after the first postoperative day, without risking subsequent lead rotation-related anatomical shifts.

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“…However, adverse effects which may be caused by lesions cannot be averted once surgery is performed (Kringelbach et al, 2007;Munro-Davies et al, 1999). On the other hand, DBS was shown to provide similar clinical benefit compared to a lesion-based therapy while avoiding permanent brain damage which might occur with lesioning (Benabid et al, 1987;Obeso et al, 2001;Vitek et al, 2020). The success of DBS surgery directly relates to the accurate identification of target regions (Paek et al, 2013;Patel et al, 2015;Patriat et al, 2018;Richardson et al, 2009;Rolston et al, 2016;Welter et al, 2014), thus greatly motivating the need for an accurate, robust and reliable identification of these brain areas in an automated manner.…”

Section: Discussionmentioning

confidence: 99%

Deep-learning based fully automatic segmentation of the globus pallidus interna and externa using ultra-high 7 Tesla MRI

Solomon

Palnitkar

Patriat

et al. 2020

Preprint

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Deep brain stimulation (DBS) surgery has been shown to dramatically improve the quality of life for patients with various motor dysfunctions, such as those afflicted with Parkinson's disease (PD), dystonia and essential tremor (ET), by relieving motor symptoms associated with such pathologies. The success of DBS procedures is directly related to the proper placement of the electrodes, which requires the ability to accurately detect and identify relevant target structures within the subcortical basal ganglia region. In particular, accurate and reliable segmentation of the globus pallidus (GP) interna is of great interest for DBS surgery for PD and dystonia. In this work, we present a deep-learning based neural network, which we term GP-net, for the automatic segmentation of both the external and internal segments of the globus pallidus. High resolution 7 Tesla images from 101 subjects were used in this study; GP-net is trained on a cohort of 58 subjects, containing patients with movement disorders as well as healthy control subjects. GP-net performs 3D inference in a patient-specific manner, alleviating the need for atlas-based segmentation. GP-net was extensively validated, both quantitatively and qualitatively over 43 test subjects including patients with movement disorders and healthy control and is shown to consistently produce improved segmentation results compared with state-of-the-art atlas-based segmentations. We also demonstrate a post-operative lead location assessment with respect to a segmented globus pallidus obtained by GP-net.

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Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study

Cited by 93 publications

References 23 publications

7T MRI and Computational Modeling Supports a Critical Role of Lead Location in Determining Outcomes for Deep Brain Stimulation: A Case Report

7T MRI and Computational Modeling Supports a Critical Role of Lead Location in Determining Outcomes for Deep Brain Stimulation: A Case Report

Longitudinal Assessment of Rotation Angles after Implantation of Directional Deep Brain Stimulation Leads

Deep-learning based fully automatic segmentation of the globus pallidus interna and externa using ultra-high 7 Tesla MRI

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