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Article: Clinical Benefit of Vagus Nerve Stimulation for Epilepsy: Assessment of Randomized Controlled Trials and Prospective Non-Randomized Studies.

Cramer, Samuel W / McGovern, Robert A / Chen, Clark C / Park, Michael C

Journal of central nervous system disease

2023 Volume 15, Page(s) 11795735231151830

Abstract: We examined the efficacy of vagal nerve stimulation (VNS) for patients suffering from medically intractable epilepsy. Four randomized controlled trials (RCTs - 3 adult RCTs and 1 pediatric RCT) were identified in our comprehensive literature search. ... ...

Abstract	We examined the efficacy of vagal nerve stimulation (VNS) for patients suffering from medically intractable epilepsy. Four randomized controlled trials (RCTs - 3 adult RCTs and 1 pediatric RCT) were identified in our comprehensive literature search. Across the 4 studies, high frequency VNS stimulation (frequency >20 Hz) consistently achieved a greater seizure frequency reduction (23.4-33.1%) relative to low frequency VNS stimulation (1 Hz, .6-15.2%). We identified 2 RCTs examining whether the parameters of stimulation influenced seizure control. These studies reported that VNS achieved seizure control comparable to those reported by the first 4 RCTs (22-43% seizure frequency reduction), irrespective of the parameters utilized for VNS stimulation. In terms of VNS associated morbidity, these morbidities were consistently higher in adults who underwent high frequency VNS stimulation (eg dysphonia 37-66%, dyspnea 6-25.3%). However, no such differences were observed in the pediatric population. Moreover, <2% of patients withdrew from the RCTs/prospective studies due to intolerable symptoms. To provide an assessment of how the risks and benefits of VNS impact the patient experience, 1 study assessed the well-being of enrolled patients (as a secondary end point) and found VNS was associated with an overall improvement in well-being. Consistent with this observation, we identified a prospective, non-randomized study that demonstrated improved quality of life for epilepsy patients managed with VNS and best medical practice relative to best medical practice alone. In aggregate, these RCT studies support the efficacy and benefit of VNS as a neuro-modulatory platform in the management of a subset of medically refractory epilepsy patients.
Language	English
Publishing date	2023-01-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2586873-1
ISSN	1179-5735
ISSN	1179-5735
DOI	10.1177/11795735231151830
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Article ; Online: Neural signal data collection and analysis of Percept™ PC BrainSense recordings for thalamic stimulation in epilepsy.

Sanger, Zachary T / Henry, Thomas R / Park, Michael C / Darrow, David / McGovern, Robert A / Netoff, Theoden I

Journal of neural engineering

2024 Volume 21, Issue 1

Abstract: Deep brain stimulation (DBS) using Medtronic's Percept™ PC implantable pulse generator is FDA-approved for treating Parkinson's disease (PD), essential tremor, dystonia, obsessive compulsive disorder, and epilepsy. Percept™ PC enables simultaneous ... ...

Abstract	Deep brain stimulation (DBS) using Medtronic's Percept™ PC implantable pulse generator is FDA-approved for treating Parkinson's disease (PD), essential tremor, dystonia, obsessive compulsive disorder, and epilepsy. Percept™ PC enables simultaneous recording of neural signals from the same lead used for stimulation. Many Percept™ PC sensing features were built with PD patients in mind, but these features are potentially useful to refine therapies for many different disease processes. When starting our ongoing epilepsy research study, we found it difficult to find detailed descriptions about these features and have compiled information from multiple sources to understand it as a tool, particularly for use in patients other than those with PD. Here we provide a tutorial for scientists and physicians interested in using Percept™ PC's features and provide examples of how neural time series data is often represented and saved. We address characteristics of the recorded signals and discuss Percept™ PC hardware and software capabilities in data pre-processing, signal filtering, and DBS lead performance. We explain the power spectrum of the data and how it is shaped by the filter response of Percept™ PC as well as the aliasing of the stimulation due to digitally sampling the data. We present Percept™ PC's ability to extract biomarkers that may be used to optimize stimulation therapy. We show how differences in lead type affects noise characteristics of the implanted leads from seven epilepsy patients enrolled in our clinical trial. Percept™ PC has sufficient signal-to-noise ratio, sampling capabilities, and stimulus artifact rejection for neural activity recording. Limitations in sampling rate, potential artifacts during stimulation, and shortening of battery life when monitoring neural activity at home were observed. Despite these limitations, Percept™ PC demonstrates potential as a useful tool for recording neural activity in order to optimize stimulation therapies to personalize treatment.
MeSH term(s)	Humans ; Deep Brain Stimulation ; Thalamus ; Epilepsy/diagnosis ; Epilepsy/therapy ; Parkinson Disease/therapy ; Essential Tremor/diagnosis ; Essential Tremor/therapy
Language	English
Publishing date	2024-02-06
Publishing country	England
Document type	Journal Article ; Review ; Research Support, N.I.H., Extramural
ZDB-ID	2170901-4
ISSN	1741-2552 ; 1741-2560
ISSN (online)	1741-2552
ISSN	1741-2560
DOI	10.1088/1741-2552/ad1dc3
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Article ; Online: Mapping spreading depolarisations after traumatic brain injury: a pilot clinical study protocol.

Cramer, Samuel W / Pino, Isabela Peña / Naik, Anant / Carlson, Danielle / Park, Michael C / Darrow, David P

BMJ open

2022 Volume 12, Issue 7, Page(s) e061663

Abstract: Introduction: Cortical spreading depolarisation (CSD) is characterised by a near-complete loss of the ionic membrane potential of cortical neurons and glia propagating across the cerebral cortex, which generates a transient suppression of spontaneous ... ...

Abstract	Introduction: Cortical spreading depolarisation (CSD) is characterised by a near-complete loss of the ionic membrane potential of cortical neurons and glia propagating across the cerebral cortex, which generates a transient suppression of spontaneous neuronal activity. CSDs have become a recognised phenomenon that imparts ongoing secondary insults after brain injury. Studies delineating CSD generation and propagation in humans after traumatic brain injury (TBI) are lacking. Therefore, this study aims to determine the feasibility of using a multistrip electrode array to identify CSDs and characterise their propagation in space and time after TBI. Methods and analysis: This pilot, prospective observational study will enrol patients with TBI requiring therapeutic craniotomy or craniectomy. Subdural electrodes will be placed for continuous electrocorticography monitoring for seizures and CSDs as a research procedure, with surrogate informed consent obtained preoperatively. The propagation of CSDs relative to structural brain pathology will be mapped using reconstructed CT and electrophysiological cross-correlations. The novel use of multiple subdural strip electrodes in conjunction with brain morphometric segmentation is hypothesised to provide sufficient spatial information to characterise CSD propagation across the cerebral cortex and identify cortical foci giving rise to CSDs. Ethics and dissemination: Ethical approval for the study was obtained from the Hennepin Healthcare Research Institute's ethics committee, HSR 17-4400, 25 October 2017 to present. Study findings will be submitted for publication in peer-reviewed journals and presented at scientific conferences. Trial registration number: NCT03321370.
MeSH term(s)	Brain Injuries/surgery ; Brain Injuries, Traumatic ; Cerebral Cortex ; Cortical Spreading Depression/physiology ; Humans ; Observational Studies as Topic ; Seizures
Language	English
Publishing date	2022-07-13
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-061663
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Article ; Online: Frequency settings of subthalamic nucleus DBS for Parkinson's disease: A systematic review and network meta-analysis.

Dharnipragada, Rajiv / Denduluri, Lalitha S / Naik, Anant / Bertogliat, Mario / Awad, Matthew / Ikramuddin, Salman / Park, Michael C

Parkinsonism & related disorders

2023 Volume 116, Page(s) 105809

Abstract: Introduction: Deep Brain Stimulation (DBS) is an effective treatment for the motor symptoms of Parkinson's Disease. The targeted physiological structure for lead location is commonly the subthalamic nucleus (STN). The efficacy of DBS for improving motor ...

Abstract	Introduction: Deep Brain Stimulation (DBS) is an effective treatment for the motor symptoms of Parkinson's Disease. The targeted physiological structure for lead location is commonly the subthalamic nucleus (STN). The efficacy of DBS for improving motor symptoms is assessed via the Unified Parkinson's Disease Rating III Scale (UPDRS-III). In this study, we sought to compare the efficacy of frequency settings utilized for STN-DBS. Methods: Following PRISMA Guidelines, a search on PUBMED and MEDLINE was performed to include full-length randomized controlled trials evaluating STN-DBS. The frequency stimulation parameters and Unified Parkinson's Disease Rating Scale (UPDRS-III) outcomes were extracted in the search. High-frequency stimulation (HFS) was defined as ≥100 Hz and low-frequency stimulation (LFS) was defined as <100 Hz. A frequentist network meta-analysis was performed with odds ratios (OR) and pooling performed using the Mantel-Haenszel method. Statistics are presented as OR [95% CI]. Results: 15 studies consisting of 298 patients were included for analysis. Bilateral HFS -0.68 [-0.89; -0.46] was associated with better UPDRS-III scores compared to bilateral LFS. On the other hand, bilateral LFS with medications (MEDS) was favored over HFS with MEDS (-0.28 [-0.63; 0.07]). Bilateral LFS and MEDS, HFS and MEDS, stimulation (STIM) OFF MEDS ON, HFS, LFS, STIM OFF MEDS OFF UPDRS outcomes were ranked from best to worst outcomes. Discussion: The outcomes of this study suggest that bilateral HFS has better utility for those with no response to medication, while LFS has additive benefits to medication by improving unique symptoms via different neurophysiological mechanisms.
MeSH term(s)	Humans ; Subthalamic Nucleus ; Parkinson Disease/therapy ; Parkinson Disease/complications ; Network Meta-Analysis ; Deep Brain Stimulation/adverse effects ; Deep Brain Stimulation/methods ; Treatment Outcome
Language	English
Publishing date	2023-08-17
Publishing country	England
Document type	Meta-Analysis ; Systematic Review ; Journal Article ; Review
ZDB-ID	1311489-x
ISSN	1873-5126 ; 1353-8020
ISSN (online)	1873-5126
ISSN	1353-8020
DOI	10.1016/j.parkreldis.2023.105809
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Article ; Online: WITHDRAWN: Laterality and frequency settings of subthalamic nucleus DBS for Parkinson's disease: A systematic review and network meta-analysis.

Dharnipragada, Rajiv / Denduluri, Lalitha S / Naik, Anant / Bertogliat, Mario / Awad, Matthew / Ikramuddin, Salman / Park, Michael C

Parkinsonism & related disorders

2023 , Page(s) 105455

Language	English
Publishing date	2023-06-10
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1311489-x
ISSN	1873-5126 ; 1353-8020
ISSN (online)	1873-5126
ISSN	1353-8020
DOI	10.1016/j.parkreldis.2023.105455
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Article ; Online: Implantation accuracy of novel polyimide stereotactic electroencephalographic depth electrodes-a human cadaveric study.

Kullmann, Aura / Akberali, Farida / Van Gompel, Jaime J / McGovern, Robert A / Marsh, W Richard / Kridner, Debra / Diaz-Botia, Camilo A / Park, Michael C

Frontiers in medical technology

2024 Volume 6, Page(s) 1320762

Abstract: Introduction: Stereoelectroencephalography (sEEG) is a minimally invasive procedure that uses depth electrodes stereotactically implanted into brain structures to map the origin and propagation of seizures in epileptic patients. Implantation accuracy of ...

Abstract	Introduction: Stereoelectroencephalography (sEEG) is a minimally invasive procedure that uses depth electrodes stereotactically implanted into brain structures to map the origin and propagation of seizures in epileptic patients. Implantation accuracy of sEEG electrodes plays a critical role in the safety and efficacy of the procedure. This study used human cadaver heads, simulating clinical practice, to evaluate (1) neurosurgeon's ability to implant a new thin-film polyimide sEEG electrode according to the instructions for use (IFU), and (2) implantation accuracy. Methods: Four neurosurgeons (users) implanted 24 sEEG electrodes into two cadaver heads with the aid of the ROSA robotic system. Usability was evaluated using a questionnaire that assessed completion of all procedure steps per IFU and user errors. For implantation accuracy evaluation, planned electrode trajectories were compared with post-implantation trajectories after fusion of pre- and postoperative computer tomography (CT) images. Implantation accuracy was quantified using the Euclidean distance for entry point error (EPE) and target point error (TPE). Results: All sEEG electrodes were successfully placed following the IFU without user errors, and post-implant survey of users showed favorable handling characteristics. The EPE was 1.28 ± 0.86 mm and TPE was 1.61 ± 0.89 mm. Long trajectories (>50 mm) had significantly larger EPEs and TPEs than short trajectories (<50 mm), and no differences were found between orthogonal and oblique trajectories. Accuracies were similar or superior to those reported in the literature when using similar experimental conditions, and in the same range as those reported in patients. Discussion: The results demonstrate that newly developed polyimide sEEG electrodes can be implanted as accurately as similar devices in the marker without user errors when following the IFU in a simulated clinical environment. The human cadaver ex-vivo test system provided a realistic test system, owing to the size, anatomy and similarity of tissue composition to that of the live human brain.
Language	English
Publishing date	2024-02-22
Publishing country	Switzerland
Document type	Journal Article
ISSN	2673-3129
ISSN (online)	2673-3129
DOI	10.3389/fmedt.2024.1320762
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Article ; Online: An improved measurement of the Ca

Tran, Van / Park, Michael C H / Stricker, Christian

Cell calcium

2018 Volume 71, Page(s) 86–94

Abstract: Fluorescent ... ...

Abstract	Fluorescent Ca
MeSH term(s)	Action Potentials ; Buffers ; Calcium/metabolism ; Calibration ; Computer Simulation ; Egtazic Acid/pharmacology ; Electrodes ; Fluorescence ; Indicators and Reagents ; Magnesium/pharmacology ; Reproducibility of Results ; Solutions
Chemical Substances	Buffers ; Indicators and Reagents ; Solutions ; Egtazic Acid (526U7A2651) ; Magnesium (I38ZP9992A) ; Calcium (SY7Q814VUP)
Language	English
Publishing date	2018-01-08
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	757687-0
ISSN	1532-1991 ; 0143-4160
ISSN (online)	1532-1991
ISSN	0143-4160
DOI	10.1016/j.ceca.2018.01.001
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Article ; Online: Resective epilepsy surgery: assessment of randomized controlled trials.

Cramer, Samuel W / McGovern, Robert A / Wang, Sonya G / Chen, Clark C / Park, Michael C

Neurosurgical review

2020 Volume 44, Issue 4, Page(s) 2059–2067

Abstract: Epilepsy is the most common form of chronic neurologic disease. Here, we review the available randomized controlled trials (RCTs) that examined the efficacy of resective epilepsy surgery in select patients suffering from medically intractable epilepsy ( ... ...

Abstract	Epilepsy is the most common form of chronic neurologic disease. Here, we review the available randomized controlled trials (RCTs) that examined the efficacy of resective epilepsy surgery in select patients suffering from medically intractable epilepsy (defined as persistent epilepsy despite two or more antiepileptic drugs [AEDs]). Three RCTs (two adult RCTs and one pediatric RCT) consistently supported the efficacy of resective surgery as treatment for epilepsy with semiology localized to the mesial temporal lobe. In these studies, 58-100% of the patients who underwent resective surgery achieved seizure freedom, in comparison to 0-13% of medically treated patients. In another RCT, the likelihood of seizure freedom after resective surgery was independent of the surgical approach (transSylvian [64%] versus subtemporal [62%]). Two other RCTs demonstrated that hippocampal resection is essential to optimize seizure control. But, no significant gain in seizure control was achieved beyond removing 2.5 cm of the hippocampus. Across RCTs, minor complications (deficit lasting < 3 months) and major complications (deficit > 3 months) ranged 2-5% and 5-11% respectively. However, nonincapacitating superior subquadrantic visual-field defects (not typically considered a minor or major complication) were noted in up to 55% of the surgical cohort. The available RCTs provide compelling support for resective surgery as a treatment for mesial temporal lobe epilepsy and offer insights toward optimal surgical strategy.
MeSH term(s)	Anticonvulsants/therapeutic use ; Epilepsy/drug therapy ; Epilepsy/surgery ; Humans ; Randomized Controlled Trials as Topic ; Seizures ; Treatment Outcome
Chemical Substances	Anticonvulsants
Language	English
Publishing date	2020-11-09
Publishing country	Germany
Document type	Journal Article ; Review
ZDB-ID	6907-3
ISSN	1437-2320 ; 0344-5607
ISSN (online)	1437-2320
ISSN	0344-5607
DOI	10.1007/s10143-020-01432-x
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Article ; Online: Neurosurgery residency match for international medical graduates in the United States.

Yekula, Anudeep / Sreeram, Sattwik / Dhawan, Sanjay / Sharma, Mayur / Sandoval-Garcia, Carolina / Huling, Jared D / Suri, Ashish / Belani, Kumar / Park, Michael C / Carter, Bob S / Chen, Clark C

Journal of neurosurgery

2023 Volume 140, Issue 1, Page(s) 291–298

Abstract: Objective: Training of international medical graduates (IMGs) offers opportunities for the US neurosurgery community to engage the global talent pool and impact national and international healthcare. Here, the authors analyzed the time trend of IMGs ... ...

Abstract	Objective: Training of international medical graduates (IMGs) offers opportunities for the US neurosurgery community to engage the global talent pool and impact national and international healthcare. Here, the authors analyzed the time trend of IMGs matching into US neurosurgery programs and identified potential opportunities for enhancing IMG engagement. Methods: The authors analyzed the National Resident Matching Program (NRMP) match results, NRMP program director (PD) surveys, and applicant surveys from 2013 to 2022. Regression methods were used to analyze time trends. Results: Between 2013 and 2022, the number of US neurosurgery residency positions increased by 17.6% (from 204 to 240). During this period, the percentage of IMGs matching into neurosurgery increased from 3.5% to 7%, translating into a 6.8% increase in the likelihood of a successful IMG match per year (95% CI 0.3%-13.8%, p = 0.042). The likelihoods of a successful match for US MDs and IMGs scoring > 260 on the USMLE Step 1 were > 90% and approximately 55%, respectively. In PD surveys, approximately 90% of PDs indicated that they seldom/never interview or rank IMGs. In terms of factors that influenced the PD decision for interviewing/ranking, IMGs are disadvantaged in several categories, including the ability to secure an audition elective/rotation, and proper letters of recommendation, as well as the influence of the culture on the preconceived perception of poor interpersonal skills. Conclusions: The number of IMGs matching successfully in neurosurgery has increased marginally during the past decade. The authors outline the challenges that IMGs encounter in this process and suggest strategies for considerations of IMG training in NRMP-associated institutions.
MeSH term(s)	Humans ; United States ; Internship and Residency ; Neurosurgery/education ; Foreign Medical Graduates ; Education, Medical, Graduate ; Neurosurgical Procedures
Language	English
Publishing date	2023-07-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	3089-2
ISSN	1933-0693 ; 0022-3085
ISSN (online)	1933-0693
ISSN	0022-3085
DOI	10.3171/2023.5.JNS23556
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Article ; Online: Paradoxical Modulation of STN β-Band Activity with Medication Compared to Deep Brain Stimulation.

Hill, Meghan E / Johnson, Luke A / Wang, Jing / Escobar Sanabria, David / Patriat, Rémi / Cooper, Scott E / Park, Michael C / Harel, Noam / Vitek, Jerrold L / Aman, Joshua E

Movement disorders : official journal of the Movement Disorder Society

2023 Volume 39, Issue 1, Page(s) 192–197

Abstract: Background: Excessive subthalamic nucleus (STN) β-band (13-35 Hz) synchronized oscillations has garnered interest as a biomarker for characterizing disease state and developing adaptive stimulation systems for Parkinson's disease (PD).: Objectives: ... ...

Abstract	Background: Excessive subthalamic nucleus (STN) β-band (13-35 Hz) synchronized oscillations has garnered interest as a biomarker for characterizing disease state and developing adaptive stimulation systems for Parkinson's disease (PD). Objectives: To report on a patient with abnormal treatment-responsive modulation in the β-band. Methods: We examined STN local field potentials from an externalized deep brain stimulation (DBS) lead while assessing PD motor signs in four conditions (OFF, MEDS, DBS, and MEDS+DBS). Results: The patient presented here exhibited a paradoxical increase in β power following administration of levodopa and pramipexole (MEDS), but an attenuation in β power during DBS and MEDS+DBS despite clinical improvement of 50% or greater under all three therapeutic conditions. Conclusions: This case highlights the need for further study on the role of β oscillations in the pathophysiology of PD and the importance of personalized approaches to the development of β or other biomarker-based DBS closed loop algorithms. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
MeSH term(s)	Humans ; Subthalamic Nucleus/physiology ; Deep Brain Stimulation ; Parkinson Disease ; Levodopa/therapeutic use ; Biomarkers
Chemical Substances	Levodopa (46627O600J) ; Biomarkers
Language	English
Publishing date	2023-10-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	607633-6
ISSN	1531-8257 ; 0885-3185
ISSN (online)	1531-8257
ISSN	0885-3185
DOI	10.1002/mds.29634
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