Stereotactic and Functional Neurosurgery最新文献

{"title":"Publication Rates and Characteristics of Clinical Trials in Deep Brain and Responsive Neurostimulation.","authors":"Melissa M J Chua,&nbsp;Aaron E L Warren,&nbsp;G Rees Cosgrove,&nbsp;John D Rolston","doi":"10.1159/000531161","DOIUrl":"10.1159/000531161","url":null,"abstract":"<p><strong>Introduction: </strong>Prompt dissemination of clinical trial results is essential for ensuring the safety and efficacy of intracranial neurostimulation treatments, including deep brain stimulation (DBS) and responsive neurostimulation (RNS). However, the frequency and completeness of results publication, and reasons for reporting delays, are unknown. Moreover, the patient populations, targeted anatomical locations, and stimulation parameters should be clearly reported for both reproducibility and to identify lacunae in trial design. Here, we examine DBS and RNS trials from 1997 to 2022, chart their characteristics, and examine rates and predictors of results reporting.</p><p><strong>Methods: </strong>Trials were identified using <ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link>. Associated publications were identified using <ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link> and <ext-link ext-link-type=\"uri\" xlink:href=\"http://PubMed.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">PubMed.gov</ext-link>. Pearson's χ2 tests were used to assess differences in trial characteristics between published and unpublished trials.</p><p><strong>Results: </strong>Across 449 trials, representing a cumulative cohort of 42,769 patient interventions, there were 37 therapeutic indications and 44 stimulation targets. The most common indication and target were Parkinson's disease (40.55%) and the subthalamic nucleus (35.88%), respectively. Only 0.89% of trials were in pediatric patients (11.58% were mixed pediatric and adult). Explored targets represented 75% of potential basal ganglia targets but only 29% of potential thalamic targets. Allowing a 1-year grace period after trial completion, 34/169 (20.12%) had results reported on <ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link>, and 107/169 (63.31%) were published. ∼80% of published trials included details about stimulation parameters used. Published and unpublished trials did not significantly differ by trial characteristics.</p><p><strong>Conclusion: </strong>We highlight key knowledge and performance gaps in DBS and RNS trial research. Over one-third of trials remain unpublished &gt;1 year after completion; pediatric trials are scarce; most of the thalamus remains unexplored; about one-in-five trials fail to report stimulation parameters; and movement disorders comprise the most studied indications.</p>","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10316567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishing Minimal Clinically Important Difference in Sleep Outcomes after Spinal Cord Stimulation in Patients with Chronic Pain Disorders.","authors":"Phillip M Johansen,&nbsp;Frank A Trujillo,&nbsp;Vivian Hagerty,&nbsp;Tessa Harland,&nbsp;Gregory Davis,&nbsp;Julie G Pilitsis","doi":"10.1159/000527257","DOIUrl":"https://doi.org/10.1159/000527257","url":null,"abstract":"<p><strong>Introduction: </strong>As one of the most common medical conditions for which patients seek medical care, chronic pain can be debilitating. The relationship between chronic pain and sleep is thought to be bidirectional, suggesting that treatment of one can be beneficial to the other. There is mounting evidence that spinal cord stimulation (SCS) improves aspects of sleep. How meaningful that is to patients' lives has not been ascertained.</p><p><strong>Objective: </strong>The aim of the current study was to further elucidate the effect of SCS on sleep by examining the relationship between pain outcome measures with the insomnia severity index (ISI) and to establish the minimally clinical important difference (MCID), which is defined as the smallest noticeable change that an individual perceives as clinically significant.</p><p><strong>Materials and methods: </strong>We prospectively collected ISI, Epworth sleepiness scale (ESS), Numerical Rating Scale, McGill Pain Questionnaire-Short Form, Oswestry Disability Index, Beck Depression Inventory, and Pain Catastrophizing Scale data both pre- and postoperatively for chronic pain patients who underwent SCS placement and had long-term outcomes. The ISI is a well-studied questionnaire used to assess an individual's level of insomnia.</p><p><strong>Results: </strong>We correlated the ESS and ISI with pain outcome measures in sixty-four patients at a mean follow-up of 9.8 ± 2.9 months. The ISI showed correlations with disability as measured through the Oswestry Disability Index (p = 0.014) and depression as measured through the Beck Depression Inventory (p = 0.024). MCID values for the ISI were calculated using both anchor- and distribution-based methods. The minimal detectable change method resulted in an MCID of 2.4 points, standard error of measurement resulted in an MCID of 2.6 points, and the change difference resulted in an MCID of 2.45. The receiver operating characteristic method yielded an MCID of 0.5-point change with an area under the curve of 0.61.</p><p><strong>Conclusion: </strong>This study successfully established MCID ranges for the ISI outcome measure to help gauge improvement in insomnia after SCS. The ISI has ample evidence of its validity in assessment of insomnia, and MCID values of 2.4-2.6 correlate with improvement in disability and depression in our patients.</p>","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10856566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Initiating a Magnetic Resonance-Guided Focused Ultrasound Program: Comprehensive Workflow and Lessons Learned from the Initial 116 Cases.","authors":"Daniel Y Zhang,&nbsp;John J Pearce,&nbsp;Jacob Mazza,&nbsp;Edgar Petrosyan,&nbsp;Alireza Borghei,&nbsp;Neepa Patel,&nbsp;Sepehr Sani","doi":"10.1159/000528925","DOIUrl":"https://doi.org/10.1159/000528925","url":null,"abstract":"<p><strong>Introduction: </strong>Magnetic resonance-guided focused ultrasound (MRgFUS) represents an incisionless treatment option for essential or parkinsonian tremor. The incisionless nature of this procedure has garnered interest from both patients and providers. As such, an increasing number of centers are initiating new MRgFUS programs, necessitating development of unique workflows to optimize patient care and safety. Herein, we describe establishment of a multi-disciplinary team, workflow processes, and outcomes for a new MRgFUS program.</p><p><strong>Methods: </strong>This is a single-academic center retrospective review of 116 consecutive patients treated for hand tremor between 2020 and 2022. MRgFUS team members, treatment workflow, and treatment logistics were reviewed and categorized. Tremor severity and adverse events were evaluated at baseline, 3, 6, and 12 months post-MRgFUS with the Clinical Rating Scale for Tremor Part B (CRST-B). Trends in outcome and treatment parameters over time were assessed. Workflow and technical modifications were noted.</p><p><strong>Results: </strong>The procedure, workflow, and team members remained consistent throughout all treatments. Technique modifications were attempted to reduce adverse events. A significant reduction in CRST-B score was achieved at 3 months (84.5%), 6 months (79.8%), and 12 months (72.2%) post-procedure (p < 0.0001). The most common post-procedure adverse events in the acute period (<1 day) were gait imbalance (61.1%), fatigue and/or lethargy (25.0%), dysarthria (23.2%), headache (20.4%), and lip/hand paresthesia (13.9%). By 12 months, the majority of adverse events had resolved with a residual 17.8% reporting gait imbalance, 2.2% dysarthria, and 8.9% lip/hand paresthesia. No significant trends in treatment parameters were found.</p><p><strong>Conclusions: </strong>We demonstrate the feasibility of establishing an MRgFUS program with a relatively rapid increase in evaluation and treatment of patients while maintaining high standards of safety and quality. While efficacious and durable, adverse events occur and can be permanent in MRgFUS.</p>","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9637452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESSFN The Mission","authors":"","doi":"10.1159/000528596","DOIUrl":"https://doi.org/10.1159/000528596","url":null,"abstract":"","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48898268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term Follow-Up of Unilateral Deep Brain Stimulation Targeting the Caudal Zona Incerta in 13 Patients with Parkinsonian Tremor.","authors":"Rasmus Stenmark Persson, Anders Fytagoridis, Maxim Ryzhkov, Marwan Hariz, Patric Blomstedt","doi":"10.1159/000533793","DOIUrl":"10.1159/000533793","url":null,"abstract":"<p><strong>Introduction: </strong>Deep brain stimulation (DBS) is an established treatment for Parkinson's disease (PD) and other movement disorders. The ventral intermediate nucleus of the thalamus is considered as the target of choice for tremor disorders, including tremor-dominant PD not suitable for DBS in the subthalamic nucleus (STN). In the last decade, several studies have shown promising results on tremor from DBS in the posterior subthalamic area (PSA), including the caudal zona incerta (cZi) located posteromedial to the STN. The aim of this study was to evaluate the long-term effect of unilateral cZi/PSA-DBS in patients with tremor-dominant PD.</p><p><strong>Methods: </strong>Thirteen patients with PD with medically refractory tremor were included. The patients were evaluated using the motor part of the Unified Parkinson Disease Rating Scale (UPDRS) off/on medication before surgery and off/on medication and stimulation 1-2 years (short-term) after surgery and at a minimum of 3 years after surgery (long-term).</p><p><strong>Results: </strong>At short-term follow-up, DBS improved contralateral tremor by 88% in the off-medication state. This improvement persisted after a mean of 62 months. Contralateral bradykinesia was improved by 40% at short-term and 20% at long-term follow-up, and the total UPDRS-III by 33% at short-term and by 22% at long-term follow-up with stimulation alone.</p><p><strong>Conclusions: </strong>Unilateral cZi/PSA-DBS seems to remain an effective treatment for patients with severe Parkinsonian tremor several years after surgery. There was also a modest improvement on bradykinesia.</p>","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10711752/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50162990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ASSFN Society News","authors":"","doi":"10.1159/000534326","DOIUrl":"https://doi.org/10.1159/000534326","url":null,"abstract":"","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136374309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ESSFN The Mission","authors":"","doi":"10.1159/000533485","DOIUrl":"https://doi.org/10.1159/000533485","url":null,"abstract":"","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136217508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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.","authors":"Kaylee R Henry, Milina Michelle Miulli, Noa B Nuzov, Mark J Nolt, Joshua M Rosenow, Behzad Elahi, Julie Pilitsis, Laleh Golestanirad","doi":"10.1159/000531644","DOIUrl":"10.1159/000531644","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>All leads significantly deviated from the intended 0° orientation (p &lt; 0.001), regardless of DBS lead design (p &lt; 0.05) or institution (p &lt; 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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10866684/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10285000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acute V3 Hypesthesia following Laser Interstitial Thermal Therapy for Drug-Resistant Epilepsy.","authors":"Jordan L W Lam,&nbsp;Emily L Levin","doi":"10.1159/000533224","DOIUrl":"10.1159/000533224","url":null,"abstract":"<p><p>Three studies have reported trigeminal hypesthesia following temporal lobe resection. However, no cases of hypesthesia have been reported following laser interstitial thermal therapy (LITT). We report the first case of trigeminal hypesthesia as a complication of otherwise successful LITT in a patient with drug-resistant epilepsy. A 58-year-old male with drug-resistant epilepsy secondary to a left parahippocampal gyrus multinodular and vacuolating neuronal tumor underwent biopsy and MRI-guided LITT. Immediately postoperatively, the patient reported hypesthesia in the left V3 distribution, including inside the mouth and ear. At 6-month follow-up, hypesthesia was present but improving, and the patient was seizure-free. While the cerebellopontine angle and prepontine cisterns are considered thermal insulators, we hypothesize that thermal injury was conducted through these spaces to the cisternal segment of the trigeminal nerve or to the inferior V3 branch in Meckel's cave. Moreover, real-time visualization of the ablation is impacted by a blind spot at the skull base, created from bone disruption of MRI thermography.</p>","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10041904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Synthetic Inversion Image Generation using MP2RAGE T1 Mapping for Surgical Targeting in Deep Brain Stimulation and Lesioning.","authors":"Erik H Middlebrooks,&nbsp;Shengzhen Tao,&nbsp;Xiangzhi Zhou,&nbsp;Elena Greco,&nbsp;Erin M Westerhold,&nbsp;Philip W Tipton,&nbsp;Alfredo Quinones-Hinojosa,&nbsp;Sanjeet S Grewal,&nbsp;Vishal Patel","doi":"10.1159/000533259","DOIUrl":"10.1159/000533259","url":null,"abstract":"<p><strong>Background: </strong>Advances in MRI technology have increased interest in direct targeting for deep brain stimulation (DBS). Various imaging sequences have been shown to provide increased contrast of numerous common DBS targets, such as T1-weighted, Fast Gray Matter Acquisition T1 Inversion Recovery (FGATIR), gray matter nulled, and Edge-Enhancing Gradient Echo (EDGE); however, the continual increase in the number of necessary sequences has led to an increase in imaging time, which is undesirable. Additionally, carefully timed inversion pulses can often lead to less-than-ideal contrast in some subjects, particularly in ultra-high field MRI, where B1+ field inhomogeneity can lead to substantial contrast variation.</p><p><strong>Objectives: </strong>This study proposes using 3D MP2RAGE-based T1 maps to retrospectively synthesize images of any desired inversion time, including T1-weighted, FGATIR, and EDGE contrasts, to visualize specific DBS targets at both 3T and 7T.</p><p><strong>Method: </strong>First, a systematic sequence optimization framework was applied to optimize MP2RAGE T1 mapping sequence parameters for the purpose of DBS planning. Next, we show that synthetic inversion-time images can be generated through a mathematical transformation of the T1 maps. The sequence was then applied to patients undergoing preoperative planning for DBS at 3T and 7T to generate synthetic contrasts used in surgical planning.</p><p><strong>Results: </strong>We show that synthetic image contrasts can be generated across a full range of inversion times at 3T and 7T, including commonly used sequences for DBS targeting, such as T1-weighted, FGATIR, and EDGE. Acquisition through a single sequence shortens scan time compared to acquiring the sequences independently without affecting image quality or contrast.</p><p><strong>Conclusions: </strong>The generation of synthetic images for DBS targeting allows faster acquisition of many key sequences, as well as the ability to optimize contrast properties post-acquisition to account for the variable B1+ effects present in ultra-high field MRI. The proposed approach has the potential to reduce imaging time and improve the accuracy of DBS targeting at 1.5T, 3T, and 7T.</p>","PeriodicalId":22078,"journal":{"name":"Stereotactic and Functional Neurosurgery","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10048194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}