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BACKGROUND: Treatment options for Parkinson's disease (PD) include both medical and surgical approaches. Deep brain stimulation (DBS) is a surgical procedure that aims to improve motor symptomatology. OBSERVATIONS: A 66-year-old White male with a 9-year history of PD presented to the neurosurgery clinic for DBS consideration. On the morning of scheduled surgery, preoperative laboratory test results revealed a prolonged prothrombin time of 50 seconds. Surgery was postponed, and further work-up revealed that the patient had a positive test result for lupus anticoagulant (LA). DBS implantation was performed 2 months later. The first stage of surgery was uneventful. The patient returned 1 week later for the second stage. Postoperatively, the patient exhibited a diminished level of consciousness. Computed tomography revealed left frontal intraparenchymal hemorrhage with surrounding edema, trace subarachnoid hemorrhage, intraventricular hemorrhage, and midline shift. LESSONS: The authors suspect that the hemorrhage occurred secondary to venous infarct, because LA is associated with a paradoxically increased risk of thrombosis. Although there is no documented association between LA and acute or delayed hemorrhage, this case demonstrates a possible relationship in a patient following DBS placement. More research is needed to confirm an association with coexisting LA with PD and an increased hemorrhage risk in neurosurgical interventions.

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BACKGROUND: Deep brain stimulation (DBS) is a powerful surgical option for drug-resistant movement disorders; however, electromagnetic interference (EMI) from external sources poses a potential risk for implanted electronics. OBSERVATIONS: A 61-year-old woman with Parkinson's disease originally had two implantable pulse generators (IPGs) for bilateral subthalamic DBS, which were then replaced with one dual-channel IPG routed in a loop. After the replacement surgery, with the same DBS programming as before the IPG replacement (bipolar setting for right, unipolar setting for left), the patient began to complain of transient paroxysmal diplopia. After multiple attempts to adjust the stimulation parameters, the diplopia was resolved by changing the left unipolar setting to a bipolar setting. At the authors' institution, before the present case, four other patients had undergone IPG replacement with loop routing. None of these previous patients complained of diplopia; however, two of the four presented with diplopia in an experimental unipolar setting. LESSONS: Clinicians should be aware that loop-routed circuits may generate distortion of the stimulus field in DBS, even in the absence of external EMI sources.

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BACKGROUND: Deep brain stimulation (DBS) is a U.S. Food and Drug Administration-approved therapy for medically refractory Parkinson's disease, essential tremor, and other neurological conditions. The procedure requires prolonged immobility and can result in significant patient discomfort, potentially limiting patient selection. In addition, surgical requirements necessitate avoidance of medications that may alter or suppress the patient's arousal or baseline tremor during macrostimulation testing. OBSERVATIONS: In this study, the authors describe the use of continuous spinal anesthesia with local anesthetic to manage a patient with severe back pain who was intolerant of semisupine position during stereotactic computed tomography and stage 1 of DBS placement. LESSONS: Continuous spinal anesthesia is an effective strategy to manage patients with severe back pain undergoing DBS surgery for upper extremity motor symptoms.

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OBJECTIVE: High-frequency deep brain stimulation (DBS) of the subthalamic nucleus (STN) is effective in the treatment of motor symptoms of Parkinson's disease. Using a patient-specific lead and volume of tissue activated (VTA) software, it is possible to visualize contact positions in the context of the patient's own anatomy. In this study, the authors' aim was to demonstrate that VTA software can be used in clinical practice to help determine the clinical effectiveness of stimulation in patients with Parkinson's disease undergoing DBS of the STN. METHODS: Brain images of 26 patients undergoing STN DBS were analyzed using VTA software. Preoperative clinical and neuropsychological data were collected. Contacts were chosen by two experts in DBS blinded to the clinical data. A therapeutic window of amplitude was determined. These results were compared with the parameter settings for each patient. Data were obtained at 3 months and 1 year postsurgery. RESULTS: In 90.4% (95% CI 82%-98%) of the patients, the contacts identified by the VTA software were concordant with the clinically effective contacts or with an effective contact in contact-by-contact testing. The therapeutic window of amplitude selected virtually included 81.3% of the clinical amplitudes. CONCLUSIONS: VTA software appears to present significant concordance with clinical data for selecting contacts and stimulation parameters that could help in postoperative follow-up and programming.

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OBJECTIVE: In the absence of a standard or guideline for the treatment of epilepsy patients with deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT), systematic single-center investigations are essential to establish effective approaches. Here, the authors report on the long-term results of one of the largest single-center ANT DBS cohorts. METHODS: The outcome data of 23 consecutive patients with transventricularly implanted electrodes were retrospectively analyzed with regard to adverse events, lead placement, stimulation-related side effects, and changes in seizure frequency. Depression and quality-of-life scores were collected in a subgroup of 9 patients. RESULTS: All but 2 patients initially underwent bilateral implantation, and 84.4% of all DBS leads were successfully located within the ANT. The mean follow-up time was 46.57 ± 23.20 months. A seizure reduction > 50% was documented in 73.9% of patients, and 34.6% achieved an Engel class I outcome. In 3 patients, clinical response was achieved by switching the electrode contact or changing from the monopolar to bipolar stimulation mode. Unilateral implantation seemed ineffective, whereas bilateral stimulation with successful ANT implantation only on one side led to a clinical response. Double stimulation with additional vagus nerve stimulation was safe. Changes in cycling mode or stimulation amplitude influenced therapy tolerability and, only to a lesser extent, seizure frequency. Side effects were rare and typically vanished by lowering the stimulation amplitude or changing the active electrode contact. Furthermore, depression and aspects of quality of life significantly improved with ANT DBS treatment. CONCLUSIONS: The transventricular approach as well as double stimulation proved safe. The anteroventral ANT appeared to be the most efficacious stimulation site. This systematic investigation with reluctant medication changes allowed for the development of a better idea of the association between parameter changes and outcome in ANT DBS patients, but larger samples are still needed to assess the potential of bipolar stimulation and distinct cycling frequencies. Furthermore, more multifaceted and objective assessments of treatment outcome are needed to fully assess the effects of ANT DBS treatment.

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OBJECTIVE: Few studies have reported long-term outcomes of globus pallidus internus (GPi) deep brain stimulation (DBS) in Parkinson's disease (PD). The authors aimed to investigate long-term outcomes of bilateral GPi DBS for 5 years and beyond for PD patients. METHODS: The authors retrospectively analyzed the clinical outcomes in 65 PD patients treated with bilateral GPi DBS at a single center. The outcome measures of motor symptoms and health-related quality of life (HRQoL) included the Unified Parkinson's Disease Rating Scale (UPDRS) and the Parkinson's Disease Questionnaire (PDQ-39). Scores at baseline were compared with those at 1, 3, 5, and 6-8 years after implantation using Wilcoxon signed-rank tests with α correction. RESULTS: GPi DBS significantly improved the off-medication UPDRS III total scores, UPDRS IV, and dyskinesia score at 1 year when compared with baseline (all p < 0.001). The off- and on-medication tremor scores, UPDRS IV, and dyskinesia scores showed moderate and sustained improvement (the ranges of the mean percentage improvement at each time point were 61%-75%, 30%-80%, 29%-40%, and 40%-65%, respectively) despite lacking statistical significance at long-term follow-up with diminishing sample sizes. The off-medication UPDRS III total scores did not show significant improvement at 5 years or later, primarily because of worsening in rigidity, akinesia, speech, gait, and postural stability scores. The on-medication UPDRS III total scores also worsened over time, with a significant worsening at 6-8 years when compared with baseline (p = 0.008). The HRQoL analyses based on the PDQ-39 revealed significant improvement in the activities of daily living and discomfort domains at 1 year (p = 0.003 and 0.006, respectively); however, all the domains showed gradual worsening at the later time points without reaching statistical significance. At 3 years, the communication domain showed significant worsening compared with baseline scores (p = 0.002). CONCLUSIONS: GPi DBS in PD patients in this single-center cohort was associated with sustained long-term benefits in the off- and on-medication tremor score and motor complications. HRQoL and the cardinal motor symptoms other than tremor may worsen gradually in the long term. When counseling patients, it is important to recognize that benefits in tremor and dyskinesia are expected to be most persistent following bilateral GPi DBS implantation.

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OBJECTIVE: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is known to reduce motor symptoms of Parkinson's disease (PD). The effects of DBS on various nonmotor symptoms often differ from patient to patient. The factors that determine whether or not a patient will respond to treatment have not been elucidated. Here, the authors evaluated sex differences in pain relief after DBS for PD. METHODS: The authors prospectively evaluated 20 patients preoperatively and postoperatively after bilateral STN DBS with the validated numeric rating scale (NRS), Revised Oswestry Disability Index for low-back pain (RODI), and King's Parkinson's Disease Pain Scale (KPDPS) and assessed the impact of sex as a biological variable. RESULTS: The cohort consisted of 6 female and 14 male patients with a mean duration of 11.8 ± 2.0 months since DBS surgery. Females were significantly older (p = 0.02). Covariate analysis, however, showed no effect of age, stimulation settings, or other confounding variables. KPDPS total scores statistically significantly improved only among males (p < 0.001). Males improved more than females in musculoskeletal and chronic subsets of the KPDPS (p = 0.03 and p = 0.01, respectively). RODI scores significantly improved in males but not in females (p = 0.03 and p = 0.30, respectively). Regarding the NRS score, the improvements seen in both sexes in NRS were not significant. CONCLUSIONS: Although it is well recognized that pain complaints in PD are different between men and women, this study is unique in that it examines the sex-specific DBS effects on this symptom. Considering sex as a biological variable may have important implications for DBS pain outcome studies moving forward.

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OBJECTIVE: The goal of this study was to systematically review the feasibility and safety of minimally invasive neurovascular approaches to brain-machine interfaces (BMIs). METHODS: A systematic literature review was performed using the PubMed database for studies published between 1986 and 2019. All studies assessing endovascular neural interfaces were included. Additional studies were selected based on review of references of selected articles and review articles. RESULTS: Of the 53 total articles identified in the original literature search, 12 studies were ultimately selected. An additional 10 articles were included from other sources, resulting in a total of 22 studies included in this systematic review. This includes primarily preclinical studies comparing endovascular electrode recordings with subdural and epidural electrodes, as well as studies evaluating stent-electrode gauge and material type. In addition, several clinical studies are also included. CONCLUSIONS: Endovascular stent-electrode arrays provide a minimally invasive approach to BMIs. Stent-electrode placement has been shown to be both efficacious and safe, although further data are necessary to draw comparisons between subdural and epidural electrode measurements given the heterogeneity of the studies included. Greater access to deep-seated brain regions is now more feasible with stent-electrode arrays; however, further validation is needed in large clinical trials to optimize this neural interface. This includes the determination of ideal electrode material type, venous versus arterial approaches, the feasibility of deep brain stimulation, and more streamlined computational decoding techniques.

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The thalamic ventral intermediate nucleus (VIM) can be targeted for treatment of tremor by several procedures, including deep brain stimulation (DBS) and, more recently, MR-guided focused ultrasound (MRgFUS). To date, such targeting has relied predominantly on coordinate-based or atlas-based techniques rather than directly targeting the VIM based on imaging features. While general regional differences of features within the thalamus and some related white matter tracts can be distinguished with conventional imaging techniques, internal nuclei such as the VIM are not discretely visualized. Advanced imaging methods such as quantitative susceptibility mapping (QSM) and fast gray matter acquisition T1 inversion recovery (FGATIR) MRI and high-field MRI pulse sequences that improve the ability to image the VIM region are emerging but have not yet been shown to have reliability and accuracy to serve as the primary method of VIM targeting. Currently, the most promising imaging approach to directly identify the VIM region for clinical purposes is MR diffusion tractography.In this review and update, the capabilities and limitations of conventional and emerging advanced methods for evaluation of internal thalamic anatomy are briefly reviewed. The basic principles of tractography most relevant to VIM targeting are provided for familiarization. Next, the key literature to date addressing applications of DTI and tractography for DBS and MRgFUS is summarized, emphasizing use of direct targeting. This literature includes 1-tract (dentatorubrothalamic tract [DRT]), 2-tract (pyramidal and somatosensory), and 3-tract (DRT, pyramidal, and somatosensory) approaches to VIM region localization through tractography.The authors introduce a 3-tract technique used at their institution, illustrating the oblique curved course of the DRT within the inferior thalamus as well as the orientation and relationship of the white matter tracts in the axial plane. The utility of this 3-tract tractography approach to facilitate VIM localization is illustrated with case examples of variable VIM location, targeting superior to the anterior commissure-posterior commissure plane, and treatment in the setting of pathologic derangement of thalamic anatomy. Finally, concepts demonstrated with these case examples and from the prior literature are synthesized to highlight several potential advantages of tractography for VIM region targeting.

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Schizophrenia is a psychiatric disorder associated with significant morbidity and mortality. Although antipsychotic medications and electroconvulsive therapy can be used to manage the clinical symptoms of schizophrenia, a substantial portion (10%-30%) of patients do not clinically respond to these treatments or cannot tolerate the side effects. Recently, deep brain stimulation (DBS) has emerged as a promising safe and effective therapeutic intervention for various psychiatric disorders. Here, the authors explore the utility of DBS of the habenula (HB) in the clinical management of 2 young adult male patients with severe, chronic, and treatment-resistant schizophrenia. After HB DBS surgery, both patients experienced improvements in clinical symptoms during the first 6 months of treatment. However, only 1 patient retained the clinical benefits and reached a favorable outcome at 12-month follow-up. The symptoms of the other patient subsequently worsened and became so profound that he needed to be hospitalized at 10-month follow-up and withdrawn from further study participation. It is tentatively concluded that HB DBS could ultimately be a relatively safe and effective surgical intervention for certain patients with treatment-resistant schizophrenia.

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The development of closed-loop deep brain stimulation (DBS) systems represents a significant opportunity for innovation in the clinical application of neurostimulation therapies. Despite the highly dynamic nature of neurological diseases, open-loop DBS applications are incapable of modifying parameters in real time to react to fluctuations in disease states. Thus, current practice for the designation of stimulation parameters, such as duration, amplitude, and pulse frequency, is an algorithmic process. Ideal stimulation parameters are highly individualized and must reflect both the specific disease presentation and the unique pathophysiology presented by the individual. Stimulation parameters currently require a lengthy trial-and-error process to achieve the maximal therapeutic effect and can only be modified during clinical visits. The major impediment to the development of automated, adaptive closed-loop systems involves the selection of highly specific disease-related biomarkers to provide feedback for the stimulation platform. This review explores the disease relevance of neurochemical and electrophysiological biomarkers for the development of closed-loop neurostimulation technologies. Electrophysiological biomarkers, such as local field potentials, have been used to monitor disease states. Real-time measurement of neurochemical substances may be similarly useful for disease characterization. Thus, the introduction of measurable neurochemical analytes has significantly expanded biomarker options for feedback-sensitive neuromodulation systems. The potential use of biomarker monitoring to advance neurostimulation approaches for treatment of Parkinson's disease, essential tremor, epilepsy, Tourette syndrome, obsessive-compulsive disorder, chronic pain, and depression is examined. Further, challenges and advances in the development of closed-loop neurostimulation technology are reviewed, as well as opportunities for next-generation closed-loop platforms.

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OBJECTIVE: Selective peripheral denervation (SPD) is a widely accepted surgery for medically refractory cervical dystonia (CD), but when SPD has failed, the available approaches are limited. The authors investigated the results from a cohort of CD patients treated with unilateral pallidotomy after unsatisfactory SPD. METHODS: The authors retrospectively analyzed patients with primary CD who underwent unilateral pallidotomy after SPD between April 2007 and August 2019. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to evaluate symptom severity before surgery, 7 days postsurgery, 3 months postsurgery, and at the last follow-up. TWSTRS subscores for disability and pain and the 24-item Craniocervical Dystonia Questionnaire (CDQ-24) were used to assess quality of life. RESULTS: At a mean final follow-up of 5 years, TWSTRS severity subscores and total scores were significantly improved (n = 12, mean improvement 57.3% and 62.3%, respectively, p = 0.0022 and p = 0.0022), and 8 of 12 patients (66.7%) were characterized as responders (improvement ≥ 25%). Patients with rotation symptoms before pallidotomy showed greater improvement in TWSTRS severity subscores than those who did not (p = 0.049). The most common adverse event was mild upper-limb weakness (n = 3). Patients' quality of life was also improved. CONCLUSIONS: Unilateral pallidotomy seems to offer an effective and safe option for patients with CD who have otherwise experienced limited benefits from SPD.

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OBJECTIVE: Despite numerous imaging studies highlighting the importance of the thalamus in a patient's surgical prognosis, human electrophysiological studies involving the limbic thalamic nuclei are limited. The objective of this study was to evaluate the safety and accuracy of robot-assisted stereotactic electrode placement in the limbic thalamic nuclei of patients with suspected temporal lobe epilepsy (TLE). METHODS: After providing informed consent, 24 adults with drug-resistant, suspected TLE undergoing evaluation with stereoelectroencephalography (SEEG) were enrolled in the prospective study. The trajectory of one electrode planned for clinical sampling of the operculoinsular cortex was modified to extend it to the thalamus, thereby preventing the need for additional electrode placement for research. The anterior nucleus of the thalamus (ANT) (n = 13) and the medial group of thalamic nuclei (MED) (n = 11), including the mediodorsal and centromedian nuclei, were targeted. The postimplantation CT scan was coregistered to the preoperative MR image, and Morel's thalamic atlas was used to confirm the accuracy of implantation. RESULTS: Ten (77%) of 13 patients in the ANT group and 10 (91%) of 11 patients in the MED group had electrodes accurately placed in the thalamic nuclei. None of the patients had a thalamic hemorrhage. However, trace asymptomatic hemorrhages at the cortical-level entry site were noted in 20.8% of patients, who did not require additional surgical intervention. SEEG data from all the patients were interpretable and analyzable. The trajectories for the ANT implant differed slightly from those of the MED group at the entry point-i.e., the precentral gyrus in the former and the postcentral gyrus in the latter. CONCLUSIONS: Using judiciously planned robot-assisted SEEG, the authors demonstrate the safety of electrophysiological sampling from various thalamic nuclei for research recordings, presenting a technique that avoids implanting additional depth electrodes or compromising clinical care. With these results, we propose that if patients are fully informed of the risks involved, there are potential benefits of gaining mechanistic insights to seizure genesis, which may help to develop neuromodulation therapies.

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OBJECTIVE: Many centers are hesitant to perform clinically indicated MRI in patients who have undergone deep brain stimulation (DBS). Highly restrictive guidelines prohibit the use of most routine clinical MRI protocols in these patients. The authors' goals were to assess the safety of spine MRI in patients with implanted DBS devices, first through phantom model testing and subsequently through validation in a DBS patient cohort. METHODS: A phantom was used to assess DBS device heating during 1.5-T spine MRI. To establish a safe spine protocol, routinely used clinical sequences deemed unsafe (a rise in temperature > 2°C) were modified to decrease the rise in temperature. This safe phantom-based protocol was then used to prospectively run 67 spine MRI sequences in 9 DBS participants requiring clinical imaging. The primary outcome was acute adverse effects; secondary outcomes included long-term adverse clinical effects, acute findings on brain MRI, and device impedance stability. RESULTS: The increases in temperature were highest when scanning the cervical spine and lowest when scanning the lumbar spine. A temperature rise < 2°C was achieved when 3D sequences were modified to 2D and when the number of slices was decreased by the minimum amount compared to routine spine MRI protocols (but there were still more slices than allowed by vendor guidelines). Following spine MRI, no acute or long-term adverse effects or acute findings on brain MR images were detected. Device impedances remained stable. CONCLUSIONS: Patients with DBS devices may safely undergo spine MRI with a fewer number of slices compared to those used in routine clinical protocols. Safety data acquisition may allow protocols outside vendor guidelines with a maximized number of slices, reducing the need for radiologist supervision.Clinical trial registration no.: NCT03753945 (ClinicalTrials.gov).

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Deep brain stimulation (DBS) of single-target nuclei has produced remarkable functional outcomes in a number of movement disorders such as Parkinson's disease, essential tremor, and dystonia. While these benefits are well established, DBS efficacy and strategy for unusual, unclassified movement disorder syndromes is less clear. A strategy of dual pallidal and thalamic electrode placement is a rational approach in such cases where there is profound, medically refractory functional impairment. The authors report a series of such cases: midbrain cavernoma hemorrhage with olivary hypertrophy, spinocerebellar ataxia-like disorder of probable genetic origin, Holmes tremor secondary to brainstem stroke, and hemiballismus due to traumatic thalamic hemorrhage, all treated by dual pallidal and thalamic DBS. All patients demonstrated robust benefit from DBS, maintained in long-term follow-up. This series demonstrates the flexibility and efficacy, but also the limitations, of dual thalamo-pallidal stimulation for managing axial and limb symptoms of tremors, dystonia, chorea, and hemiballismus in patients with complex movement disorders.

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OBJECTIVE: Low registration errors are an important prerequisite for reliable navigation, independent of its use in cranial or spinal surgery. Regardless of whether navigation is used for trajectory alignment in biopsy or implant procedures, or for sophisticated augmented reality applications, all depend on a correct registration of patient space and image space. In contrast to fiducial, landmark, or surface matching-based registration, the application of intraoperative imaging allows user-independent automatic patient registration, which is less error prone. The authors' aim in this paper was to give an overview of their experience using intraoperative CT (iCT) scanning for automatic registration with a focus on registration accuracy and radiation exposure. METHODS: A total of 645 patients underwent iCT scanning with a 32-slice movable CT scanner in combination with navigation for trajectory alignment in biopsy and implantation procedures (n = 222) and for augmented reality (n = 437) in cranial and spine procedures (347 craniotomies and 42 transsphenoidal, 56 frameless stereotactic, 59 frame-based stereotactic, and 141 spinal procedures). The target registration error was measured using skin fiducials that were not part of the registration procedure. The effective dose was calculated by multiplying the dose length product with conversion factors. RESULTS: Among all 1281 iCT scans obtained, 1172 were used for automatic patient registration (645 initial registration scans and 527 repeat iCT scans). The overall mean target registration error was 0.86 ± 0.38 mm (± SD) (craniotomy, 0.88 ± 0.39 mm; transsphenoidal, 0.92 ± 0.39 mm; frameless, 0.74 ± 0.39 mm; frame-based, 0.84 ± 0.34 mm; and spinal, 0.80 ± 0.28 mm). Compared with standard diagnostic scans, a distinct reduction of the effective dose could be achieved using low-dose protocols for the initial registration scan with mean effective doses of 0.06 ± 0.04 mSv for cranial, 0.50 ± 0.09 mSv for cervical, 4.12 ± 2.13 mSv for thoracic, and 3.37 ± 0.93 mSv for lumbar scans without impeding registration accuracy. CONCLUSIONS: Reliable automatic patient registration can be achieved using iCT scanning. Low-dose protocols ensured a low radiation exposure for the patient. Low-dose scanning had no negative effect on navigation accuracy.

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Over the last two decades, deep brain stimulation (DBS) has gained popularity as a treatment of severe and medically refractory obsessive-compulsive disorder (OCD), often using brain targets informed by historical lesional neurosurgical procedures. Paradoxically, the use of DBS in OCD has led some multidisciplinary teams to revisit the use of lesional procedures, especially anterior capsulotomy (AC), although significant aversion still exists toward the use of lesional neurosurgery for psychiatric disorders. This paper aims to review all literature on the use of AC for OCD to examine its effectiveness and safety profile.All publications on AC for OCD were searched. In total 512 patients were identified in 25 publications spanning 1961-2018. In papers where a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score was available, 73% of patients had a clinical response (i.e., > 35% improvement in Y-BOCS score) and 24% patients went into remission (Y-BOCS score < 8). In the older publications, published when the Y-BOCS was not yet available, 90% of patients were deemed to have had a significant clinical response and 39% of patients were considered symptom free. The rate of serious complications was low.In summary, AC is a safe, well-tolerated, and efficacious therapy. Its underuse is likely a result of historical prejudice rather than lack of clinical effectiveness.

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OBJECTIVE: Lead placement for deep brain stimulation (DBS) using intraoperative MRI (iMRI) relies solely on real-time intraoperative neuroimaging to guide electrode placement, without microelectrode recording (MER) or electrical stimulation. There is limited information, however, on outcomes after iMRI-guided DBS for dystonia. The authors evaluated clinical outcomes and targeting accuracy in patients with dystonia who underwent lead placement using an iMRI targeting platform. METHODS: Patients with dystonia undergoing iMRI-guided lead placement in the globus pallidus pars internus (GPi) were identified. Patients with a prior ablative or MER-guided procedure were excluded from clinical outcomes analysis. Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) scores and Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores were assessed preoperatively and at 6 and 12 months postoperatively. Other measures analyzed include lead accuracy, complications/adverse events, and stimulation parameters. RESULTS: A total of 60 leads were implanted in 30 patients. Stereotactic lead accuracy in the axial plane was 0.93 ± 0.12 mm from the intended target. Nineteen patients (idiopathic focal, n = 7; idiopathic segmental, n = 5; DYT1, n = 1; tardive, n = 2; other secondary, n = 4) were included in clinical outcomes analysis. The mean improvement in BFMDRS score was 51.9% ± 9.7% at 6 months and 63.4% ± 8.0% at 1 year. TWSTRS scores in patients with predominant cervical dystonia (n = 13) improved by 53.3% ± 10.5% at 6 months and 67.6% ± 9.0% at 1 year. Serious complications occurred in 6 patients (20%), involving 8 of 60 implanted leads (13.3%). The rate of serious complications across all patients undergoing iMRI-guided DBS at the authors' institution was further reviewed, including an additional 53 patients undergoing GPi-DBS for Parkinson disease. In this expanded cohort, serious complications occurred in 11 patients (13.3%) involving 15 leads (10.1%). CONCLUSIONS: Intraoperative MRI-guided lead placement in patients with dystonia showed improvement in clinical outcomes comparable to previously reported results using awake MER-guided lead placement. The accuracy of lead placement was high, and the procedure was well tolerated in the majority of patients. However, a number of patients experienced serious adverse events that were attributable to the introduction of a novel technique into a busy neurosurgical practice, and which led to the revision of protocols, product inserts, and on-site training.

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OBJECTIVE: The goal of this study was to demonstrate the use of quantitative susceptibility mapping (QSM)-based images to precisely localize the globus pallidus internus (GPi) for deep brain stimulation (DBS) planning and to enhance postsurgical visualization of the DBS lead positions. METHODS: Presurgical T1-weighted (T1w), T2-weighted (T2w), and QSM images as well as postsurgical CT images were obtained in 29 patients with Parkinson's disease. To enhance the contrast within the GP, a hybrid contrast was created by linearly combining T1w and QSM images. Contrast-to-noise ratios (CNRs) of the GPi on T1w, T2w, QSM, and hybrid images were compared. The CNR differences were tested using the 1-way ANOVA method. The visualization of the DBS lead position was demonstrated by merging the postsurgical CT with presurgical MR images. RESULTS: The hybrid images yield the best CNRs for GPi depiction and the visualization of the postsurgical DBS lead position was significantly improved. CONCLUSIONS: QSM-based images allow for confident localization of borders of the GPi that is superior to T1w and T2w images. High-contrast hybrid images can be used for precisely directed DBS targeting, e.g., GPi DBS for the treatment of advanced Parkinson's disease.

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OBJECTIVE: The objective of this open-label, nonrandomized trial was to evaluate the efficacy and safety of bilateral caudate nucleus deep brain stimulation (DBS) for treatment-resistant tinnitus. METHODS: Six participants underwent DBS electrode implantation. One participant was removed from the study for suicidality unrelated to brain stimulation. Participants underwent a stimulation optimization period that ranged from 5 to 13 months, during which the most promising stimulation parameters for tinnitus reduction for each individual were determined. These individual optimal stimulation parameters were then used during 24 weeks of continuous caudate stimulation to reach the endpoint. The primary outcome for efficacy was the Tinnitus Functional Index (TFI), and executive function (EF) safety was a composite z-score from multiple neuropsychological tests (EF score). The secondary outcome for efficacy was the Tinnitus Handicap Inventory (THI); for neuropsychiatric safety it was the Frontal Systems Behavior Scale (FrSBe), and for hearing safety it was pure tone audiometry at 0.5, 1, 2, 3, 4, and 6 kHz and word recognition score (WRS). Other monitored outcomes included surgery- and device-related adverse events (AEs). Five participants provided full analyzable data sets. Primary and secondary outcomes were based on differences in measurements between baseline and endpoint. RESULTS: The treatment effect size of caudate DBS for tinnitus was assessed by TFI [mean (SE), 23.3 (12.4)] and THI [30.8 (10.4)] scores, both of which were statistically significant (Wilcoxon signed-rank test, 1-tailed; alpha = 0.05). Based on clinically significant treatment response categorical analysis, there were 3 responders determined by TFI (≥ 13-point decrease) and 4 by THI (≥ 20-point decrease) scores. Safety outcomes according to EF score, FrSBe, audiometric thresholds, and WRS showed no significant change with continuous caudate stimulation. Surgery-related and device-related AEs were expected, transient, and reversible. There was only one serious AE, a suicide attempt unrelated to caudate neuromodulation in a participant in whom stimulation was in the off mode for 2 months prior to the event. CONCLUSIONS: Bilateral caudate nucleus neuromodulation by DBS for severe, refractory tinnitus in this phase I trial showed very encouraging results. Primary and secondary outcomes revealed a highly variable treatment effect size and 60%-80% treatment response rate for clinically significant benefit, and no safety concerns. The design of a phase II trial may benefit from targeting refinement for final DBS lead placement to decrease the duration of the stimulation optimization period and to increase treatment effect size uniformity.Clinical trial registration no.: NCT01988688 (clinicaltrials.gov).