Retinal Prostheses: Engineering and Clinical Perspectives for Vision Restoration.

A retinal prosthesis, also known as a bionic eye, is a device that can be implanted to partially restore vision in patients with retinal diseases that have resulted in the loss of photoreceptors (e.g., age-related macular degeneration and retinitis pigmentosa). Recently, there have been major breakthroughs in retinal prosthesis technology, with the creation of numerous types of implants, including epiretinal, subretinal, and suprachoroidal sensors. These devices can stimulate the remaining cells in the retina with electric signals to create a visual sensation. A literature review of the pre-clinical and clinical studies published between 2017 and 2023 is conducted. This narrative review delves into the retinal anatomy, physiology, pathology, and principles underlying electronic retinal prostheses. Engineering aspects are explored, including electrode-retina alignment, electrode size and material, charge density, resolution limits, spatial selectivity, and bidirectional closed-loop systems. This article also discusses clinical aspects, focusing on safety, adverse events, visual function, outcomes, and the importance of rehabilitation programs. Moreover, there is ongoing debate over whether implantable retinal devices still offer a promising approach for the treatment of retinal diseases, considering the recent emergence of cell-based and gene-based therapies as well as optogenetics. This review compares retinal prostheses with these alternative therapies, providing a balanced perspective on their advantages and limitations. The recent advancements in retinal prosthesis technology are also outlined, emphasizing progress in engineering and the outlook of retinal prostheses. While acknowledging the challenges and complexities of the technology, this article highlights the significant potential of retinal prostheses for vision restoration in individuals with retinal diseases and calls for continued research and development to refine and enhance their performance, ultimately improving patient outcomes and quality of life.

[How to: Basics of programming cardiac pacemakers]. / How to: Basics der Schrittmacherprogrammierung.

Programming of implantable cardiac devices, especially dual-chamber pacemakers, can be challenging in daily clinical practice. Precise knowledge of programmable parameters is important; furthermore, one should also be familiar with the specific algorithms of each manufacturer. During programming, the patient's individual requirements should be taken into account, but out-of-the-box programming should be avoided. Another important goal of programming should be to stimulate as much as needed but as little as possible to provide the patient good exercise capacity while not being aware of the pacing. Manufacturers' algorithms can help reach these aims but need to be understood and-in case of inappropriate behavior-to be deactivated.

MEG detection of high frequency oscillations and intracranial-EEG validation in pediatric epilepsy surgery.

OBJECTIVE: To assess the feasibility of automatically detecting high frequency oscillations (HFOs) in magnetoencephalography (MEG) recordings in a group of ten paediatric epilepsy surgery patients who had undergone intracranial electroencephalography (iEEG). METHODS: A beamforming source-analysis method was used to construct virtual sensors and an automatic algorithm was applied to detect HFOs (80-250 Hz). We evaluated the concordance of MEG findings with the sources of iEEG HFOs, the clinically defined seizure onset zone (SOZ), the location of resected brain structures, and with post-operative outcome. RESULTS: In 8/9 patients there was good concordance between the sources of MEG HFOs and iEEG HFOs and the SOZ. Significantly more HFOs were detected in iEEG relative to MEG t(71) = 2.85, p < .05. There was good concordance between sources of MEG HFOs and the resected area in patients with good and poor outcome, however HFOs were also detected outside of the resected area in patients with poor outcome. CONCLUSION: Our findings demonstrate the feasibility of automatically detecting HFOs non-invasively in MEG recordings in paediatric patients, and confirm compatibility of results with invasive recordings. SIGNIFICANCE: This approach provides support for the non-invasive detection of HFOs to aid surgical planning and potentially reduce the need for invasive monitoring, which is pertinent to paediatric patients.

What do intracerebral electrodes measure?

OBJECTIVE: Gain insight and improve our interpretation of measurements from intracerebral electrodes. Determine if interpretation of intracerebral EEG is dependent on electrode characteristics. METHODS: We use intracerebral EEG measurements differing only in the recording electrodes (Dixi or homemade electrodes), and numerical simulations to determine the spatial sensitivity of intracerebral electrodes and its dependence on several parameters. RESULTS: There is a difference in the high frequency (>20 Hz) power depending on the electrode type, which cannot be explained by the different contact sizes or distance between contacts. Simulations show that the width of the gap between electrode and brain and the extent of the generators have an effect on sensitivity, while other parameters are less important. CONCLUSIONS: The sensitivity of intracerebral electrodes is not affected in an important way by the dimensions of the contacts, but depends on the extent of generators. The unusual insertion technique of homemade electrodes resulting in a large gap between functional brain and electrodes, explains the observed signal difference. SIGNIFICANCE: Numerical simulation is a useful tool in the choice or design of intracerebral electrodes, and increases our understanding of their measurements. The interpretation of intracerebral EEG is not affected by differences between typical commercially available electrodes.

Surgical considerations during cochlear implantation: the utility of temporal bone computed tomography.

OBJECTIVE: This paper describes the construction of portals for electrode placement during cochlear implantation and emphasises the utility of pre-operative temporal bone three-dimensional computed tomography. METHODS: Temporal bone three-dimensional computed tomography was used to plan portal creation for electrode insertion. RESULTS: Pre-operative temporal bone three-dimensional computed tomography can be used to determine the orientation of temporal bone structures, which is important for mastoidectomy, posterior tympanotomy and cochleostomy, and when using the round window approach. CONCLUSION: It is essential to create appropriate portals (from the mastoid cortex to the cochlea) in a step-by-step manner, to ensure the safe insertion of electrodes into the scala tympani. Pre-operative three-dimensional temporal bone computed tomography is invaluable in this respect.

A Retrospective Review of Lead Migration Rate in Patients Permanently Implanted with Percutaneous Leads and a 10 kHz SCS Device.

Background: Spinal cord stimulation (SCS) has been used over decades for pain management, but migration of percutaneous leads has been the most common complication. Better surgical techniques and newer SCS technologies likely reduced the incidence of lead migration requiring surgical revision, although data are sparse. This study aimed to retrospectively evaluate the incidence of clinically significant percutaneous lead migration in patients permanently implanted with a 10 kHz SCS system. Methods: Consecutive patients with chronic trunk and/or limb pain, permanently implanted between January 2016 and June 2019, were included in the analysis. Data were collected from the hospital's electronic medical records and the manufacturer's database. Clinically significant lead migration, defined as diminished pain relief followed by surgery to correct lead location, was assessed at the 6-month follow-up. Results: At the 6-month follow-up, there were no cases of clinically significant lead migration, average pain relief was 65.2%, 82% of patients had response (≥50% pain relief), improvement of function was noted in 72% of patients, and decrease of medication was observed in 42% of patients. Therapy efficacy was sustained in patients with >12 months follow-up; the average pain relief was 58.5%, and the response rate was 82%. Conclusions: The surgical techniques in use today are designed to minimise the risk of percutaneous lead migration and may have reduced its incidence. In addition, new SCS systems may give greater opportunity to mitigate cases of minor lead movement using alternative stimulation programs.

Distributed source modeling of intracranial stereoelectro-encephalographic measurements.

Intracranial stereoelectroencephalography (sEEG) provides unsurpassed sensitivity and specificity for human neurophysiology. However, functional mapping of brain functions has been limited because the implantations have sparse coverage and differ greatly across individuals. Here, we developed a distributed, anatomically realistic sEEG source-modeling approach for within- and between-subject analyses. In addition to intracranial event-related potentials (iERP), we estimated the sources of high broadband gamma activity (HBBG), a putative correlate of local neural firing. Our novel approach accounted for a significant portion of the variance of the sEEG measurements in leave-one-out cross-validation. After logarithmic transformations, the sensitivity and signal-to-noise ratio were linearly inversely related to the minimal distance between the brain location and electrode contacts (slope≈-3.6). The signa-to-noise ratio and sensitivity in the thalamus and brain stem were comparable to those locations at the vicinity of electrode contact implantation. The HGGB source estimates were remarkably consistent with analyses of intracranial-contact data. In conclusion, distributed sEEG source modeling provides a powerful neuroimaging tool, which facilitates anatomically-normalized functional mapping of human brain using both iERP and HBBG data.

Navigated Deep Brain Stimulation Surgery: Evaluating the Combined Use of a Frame-Based Stereotactic System and a Navigation System.

Deep brain stimulation (DBS) is a complex surgical procedure that requires detailed anatomical knowledge. In many fields of neurosurgery navigation systems are used to display anatomical structures during an operation to aid performing these surgeries. In frame-based DBS, the advantage of visualization has not yet been evaluated during the procedure itself. In this study, we added live visualization to a frame-based DBS system, using a standard navigation system and investigated its accuracy and potential use in DBS surgery. As a first step, a phantom study was conducted to investigate the accuracy of the navigation system in conjunction with a frame-based approach. As a second step, 5 DBS surgeries were performed with this combined approach. Afterwards, 3 neurosurgeons and 2 neurologists with different levels of experience evaluated the potential use of the system with a questionnaire. Moreover, the additional personnel, costs and required set up time were noted and compared to 5 consecutive standard procedures. In the phantom study, the navigation system showed an inaccuracy of 2.1 mm (mean SD 0.69 mm). In the questionnaire, a mean of 9.4/10 points was awarded for the use of the combined approach as a teaching tool, a mean of 8.4/10 for its advantage in creating a 3-dimensional (3-D) map and a mean of 8/10 points for facilitating group discussions. Especially neurosurgeons and neurologists in training found it useful to better interpret clinical results and side effects (mean 9/10 points) and neurosurgeons appreciated its use to better interpret microelectrode recordings (mean 9/10 points). A mean of 6/10 points was awarded when asked if the benefits were worth the additional efforts. Initially 2 persons, then one additional person was required to set up the system with no relevant added time or costs. Using a navigation system for live visualization during frame-based DBS surgery can improve the understanding of the complex 3-D anatomy and many aspects of the procedure itself. For now, we would regard it as an excellent teaching tool rather than a necessity to perform DBS surgeries.

Do directional deep brain stimulation leads rotate after implantation?

BACKGROUND: The two middle contacts of directional leads (d-leads) for deep brain stimulation are split into three segments, allowing current steering toward desired axial directions. To facilitate programming, their final orientation needs to be reliably determined. However, it is currently unclear whether d-leads rotate after implantation. Our objective was to assess the degree of d-lead rotation after implantation. METHODS: We retrospectively analyzed d-lead orientation on intraoperative X-rays, postoperative CT scans (latencies to surgery: 108-189 min postoperatively), and rotational fluoroscopies (4-9 days postoperatively) for a consecutive series of 32 implanted d-leads. For five d-leads, a CT scan with a mean follow-up of 57 days (range 28-182) was available. All d-leads were implanted with the marker facing anterior and the intention to hit an "iron sight" (ISi) on the X-ray, indicating anterior orientation (i.e., 0° ± 6°). RESULTS: In nine d-leads, an ISi was visible on the final X-ray; median orientation was 1.5° (range 0.5-6.0°) at the first follow-up CT, confirming anterior orientation. In d-leads without ISi or where ISi was not evaluable, the median rotation was 15.5° (9.5-35.0°) and 26.5° (5.5-62.0°), respectively. The orientation of the initial CT was comparable with the orientation determined by the postoperative rotational fluoroscopy and second CT in all d-lead groups. CONCLUSION: D-lead orientation does not change within the first week after implantation. We provide first indications that d-lead orientation remains stable for several weeks after surgery. Determination of lead orientation using marker-based X-ray alone seems too imprecise; adding the ISi method can increase determination of intraoperative orientation.

Accuracy and Safety of Customized Stereotactic Fixtures for Stereoelectroencephalography in Pediatric Patients.

Stereoelectroencephalography (SEEG) in children with intractable epilepsy presents particular challenges. Their thin and partially ossified cranium, specifically in the temporal area, is prone to fracture while attaching stereotactic systems to the head or stabilizing the head in robot's field of action. Postponing SEEG in this special population of patients can have serious consequences, reducing their chances of becoming seizure-free and impacting their social and cognitive development. This study demonstrates the safety and accuracy offered by a frameless personalized 3D printed stereotactic implantation system for SEEG investigations in children under 4 years of age. SEEG was carried out in a 3-year-old patient with drug-resistant focal epilepsy, based on a right temporal-perisylvian epileptogenic zone hypothesis. Fifteen intracerebral electrodes were placed using a StarFix patient-customized stereotactic fixture. The median lateral entry point localization error of the electrodes was 0.90 mm, median lateral target point localization error was 1.86 mm, median target depth error was 0.83 mm, and median target point localization error was 1.96 mm. There were no perioperative complications. SEEG data led to a tailored right temporal-insular-opercular resection, with resulting seizure freedom (Engel IA). In conclusion, patient-customized stereotactic fixtures are a safe and accurate option for SEEG exploration in young children.

Deep Brain Stimulation Lead Implantation Using a Customized Rapidly Manufactured Stereotactic Fixture with Submillimetric Euclidean Accuracy.

BACKGROUND: The microTargetingTM MicrotableTM Platform is a novel stereotactic system that can be more rapidly fabricated than currently available 3D-printed alternatives. We present the first case series of patients who underwent deep brain stimulation (DBS) surgery guided by this platform and demonstrate its in vivo accuracy. METHODS: Ten patients underwent DBS at a single institution by the senior author and 15 leads were placed. The mean age was 69.1 years; four were female. The ventralis intermedius nucleus was targeted for patients with essential tremor and the subthalamic nucleus was targeted for patients with Parkinson's disease. RESULTS: Nine DBS leads in 6 patients were appropriately imaged to enable measurement of accuracy. The mean Euclidean electrode placement error (EPE) was 0.97 ± 0.37 mm, and the mean radial error was 0.80 ± 0.41 mm (n = 9). In the subset of CT scans performed greater than 1 month postoperatively (n = 3), the mean Euclidean EPE was 0.75 ± 0.17 mm and the mean radial error was 0.69 ± 0.17 mm. There were no surgical complications. CONCLUSION: The MicrotableTM platform is capable of submillimetric accuracy in patients undergoing stereotactic surgery. It has achieved clinical efficacy in our patients without surgical complications and has demonstrated the potential for superior accuracy compared to both traditional stereotactic frames and other common frameless systems.

Utility and lower limits of frequency detection in surface electrode stimulation for somatosensory brain-computer interface in humans.

OBJECTIVE: Stimulation of the primary somatosensory cortex (S1) has been successful in evoking artificial somatosensation in both humans and animals, but much is unknown about the optimal stimulation parameters needed to generate robust percepts of somatosensation. In this study, the authors investigated frequency as an adjustable stimulation parameter for artificial somatosensation in a closed-loop brain-computer interface (BCI) system. METHODS: Three epilepsy patients with subdural mini-electrocorticography grids over the hand area of S1 were asked to compare the percepts elicited with different stimulation frequencies. Amplitude, pulse width, and duration were held constant across all trials. In each trial, subjects experienced 2 stimuli and reported which they thought was given at a higher stimulation frequency. Two paradigms were used: first, 50 versus 100 Hz to establish the utility of comparing frequencies, and then 2, 5, 10, 20, 50, or 100 Hz were pseudorandomly compared. RESULTS: As the magnitude of the stimulation frequency was increased, subjects described percepts that were "more intense" or "faster." Cumulatively, the participants achieved 98.0% accuracy when comparing stimulation at 50 and 100 Hz. In the second paradigm, the corresponding overall accuracy was 73.3%. If both tested frequencies were less than or equal to 10 Hz, accuracy was 41.7% and increased to 79.4% when one frequency was greater than 10 Hz (p = 0.01). When both stimulation frequencies were 20 Hz or less, accuracy was 40.7% compared with 91.7% when one frequency was greater than 20 Hz (p < 0.001). Accuracy was 85% in trials in which 50 Hz was the higher stimulation frequency. Therefore, the lower limit of detection occurred at 20 Hz, and accuracy decreased significantly when lower frequencies were tested. In trials testing 10 Hz versus 20 Hz, accuracy was 16.7% compared with 85.7% in trials testing 20 Hz versus 50 Hz (p < 0.05). Accuracy was greater than chance at frequency differences greater than or equal to 30 Hz. CONCLUSIONS: Frequencies greater than 20 Hz may be used as an adjustable parameter to elicit distinguishable percepts. These findings may be useful in informing the settings and the degrees of freedom achievable in future BCI systems.

Surface-Based Registration of MR Scan versus Refined Anatomy-Based Registration of CT Scan: Effect on the Accuracy of SEEG Electrodes Implantation Performed in Prone Position under Frameless Neuronavigation.

INTRODUCTION: Stereoelectroencephalography (SEEG) refers to a commonly used diagnostic procedure to localise and define the epileptogenic zone of refractory focal epilepsies, by means of minimally invasive operation techniques without large craniotomies. OBJECTIVE: This study aimed to investigate the influence of different registration methods on the accuracy of SEEG electrode implantation under neuronavigation for paediatric patients with refractory epilepsy. METHODS: The clinical data of 18 paediatric patients with refractory epilepsy were retrospectively analysed. The SEEG electrodes were implanted under optical neuronavigation while the patients were in the prone position. Patients were divided into two groups on the basis of the surface-based registration of MR scan method and refined anatomy-based registration of CT scan. Registration time, accuracy, and the differences between electrode placement and preoperative planned position were analysed. RESULTS: Thirty-six electrodes in 7 patients were placed under surface-based registration of MR scan, and 45 electrodes in 11 patients were placed under refined anatomy-based registration of CT scan. The registration time of surface-based registration of MR scan and refined anatomy-based registration of CT scan was 45 ± 12 min and 10 ± 4 min. In addition, the mean registration error, the error of insertion point, and target error were 3.6 ± 0.7 mm, 2.7 ± 0.7 mm, and 3.1 ± 0.5 mm in the surface-based registration of MR scan group, and 1.1 ± 0.3 mm, 1.5 ± 0.5 mm, and 2.2 ± 0.6 mm in the refined anatomy-based registration of CT scan group. The differences between the two registration methods were statistically significant. CONCLUSIONS: The refined anatomy-based registration of CT scan method can improve the registration efficiency and electrode placement accuracy, and thereby can be considered as the preferred registration method in the application of SEEG electrode implantation under neuronavigation for treatment of paediatric intractable epilepsy.

Clinical outcomes of patients undergoing a cardiac implantable electronic device implantation following a recent non-device-related infection.

BACKGROUND: Clinical outcomes of patients undergoing a cardiac implantable electronic device (CIED) implantation following a recent non-device related infection are unknown. AIM: To evaluate the clinical outcomes of patients with recent infection before CIED implantation. METHODS: Consecutive patients (N = 1237) were classified as patients with recent infection (N = 72) and without recent infection (N = 1165). A recent infection was established by reviewing medical records, including symptoms and clinical manifestations, diagnosis of systemic inflammatory response syndrome, and quick Sequential Organ Failure Assessment (qSOFA) score. Multiple stepwise logistic regression analysis was used to identify independent predictors of in-hospital all-cause mortality. FINDINGS: During nearly three years of follow-up, 17 patients had CIED infection (1.4%), and the incidence of CIED infection did not significantly differ between patients with and without recent infection according to symptoms and clinical manifestations (2.8% vs 1.3%, respectively; not significant). However, patients with recent infection had a significantly higher in-hospital mortality rate compared to those without recent infection (22.2% vs 0.9%, respectively; P < 0.05). In multivariate analysis, predictors of in-hospital mortality were recent infection before CIED implantation (odds ratio: 20.3; 95% confidence interval: 8.4-49.3; P < 0.001) and end-stage renal disease (4.3; 1.4-12.8; P = 0.009). CONCLUSION: A CIED implantation is feasible in patients with recent infection if the patient is afebrile and has received an adequate duration of antibiotic therapy. Participants in shared decision-making before implant should be advised that recent infection increases in-hospital mortality risk, especially in patients with a qSOFA score of ≥2.

Comparison of narcotic pain control between stereotactic electrocorticography and subdural grid implantation.

INTRODUCTION: The choice of subdural grid (SDG) or stereoelectroencephalography (sEEG) for patients with epilepsy can be complex and in some cases overlap. Comparing postoperative pain and narcotics consumption with SDG or sEEG can help develop an intracranial monitoring strategy. MATERIALS AND METHODS: A retrospective study was performed for adult patients undergoing SDG or sEEG monitoring. Numeric Rating Scale (NRS) was used for pain assessment. Types and dosage of the opioids were calculated by converting into milligram morphine equivalents (MME). Narcotic consumption was analyzed at the following three time periods: I. the first 24 h of implantation; II. from the second postimplantation day to the day of explantation; and III. the days following electrode removal to discharge. RESULTS: Forty-two patients who underwent SDG and 31 patients who underwent sEEG implantation were analyzed. After implantation, average NRS was 3.7 for SDG and 2.2 for sEEG (P < .001). After explantation, the NRS was 3.5 for SDG and 1.4 in sEEG (P < .001). Sixty percent of SDG patients and 13% of sEEG patients used more than one opioid in period III (P < .001). The SDG group had a significantly higher MME throughout the three periods compared with the sEEG group: period I: 448 (SDG) vs. 205 (sEEG) mg, P = .002; period II: 377 (SDG) vs. 102 (sEEG) mg, P < .001; and period III: 328 (SDG) vs. 75 (sEEG) mg; P = .002. Patients with the larger SDG implantation had the higher NRS (P = .03) and the higher MME at period I (P = .019). There was no correlation between the number of depth electrodes and pain control in patients with sEEG. CONCLUSIONS: Patients undergoing sEEG had significantly less pain and required fewer opiates compared with patients with SDG. These differences in perioperative pain may be a consideration when choosing between these two invasive monitoring options.

Closing the Loop: Validation of Implantable Cardiac Devices With Computational Heart Models.

OBJECTIVE: Cardiovascular Implantable Electronic Devices (CIEDs) are used extensively for treating life-threatening conditions such as bradycardia, atrioventricular block and heart failure. The complicated heterogeneous physical dynamics of patients provide distinct challenges to device development and validation. We address this problem by proposing a device testing framework within the in-silico closed-loop context of patient physiology. METHODS: We develop an automated framework to validate CIEDs in closed-loop with a high-level physiologically based computational heart model. The framework includes test generation, execution and evaluation, which automatically guides an integrated stochastic optimization algorithm for exploration of physiological conditions. CONCLUSION: The results show that using a closed loop device-heart model framework can achieve high system test coverage, while the heart model provides clinically relevant responses. The simulated findings of pacemaker mediated tachycardia risk evaluation agree well with the clinical observations. Furthermore, we illustrate how device programming parameter selection affects the treatment efficacy for specific physiological conditions. SIGNIFICANCE: This work demonstrates that incorporating model based closed-loop testing of CIEDs into their design provides important indications of safety and efficacy under constrained physiological conditions.

Effect of Anesthesia on Microelectrode Recordings during Deep Brain Stimulation Surgery in Tourette Syndrome Patients.

BACKGROUND: Deep brain stimulation (DBS) is an accepted treatment for patients with medication-resistant Tourette syndrome (TS). Sedation is commonly required during electrode implantation to attenuate anxiety, pain, and severe tics. Anesthetic agents potentially impair the quality of microelectrode recordings (MER). Little is known about the effect of these anesthetics on MER in patients with TS. We describe our experience with different sedative regimens on MER and tic severity in patients with TS. METHODS: The clinical records of all TS patients who underwent DBS surgery between 2010 and 2018 were reviewed. Demographic data, stimulation targets, anesthetic agents, perioperative complications, and MER from each hemisphere were collected and analyzed. Single-unit activity was identified by filtering spiking activity from broadband MER data and principal component analysis with K-means clustering. Vocal and motor tics which caused artifacts in the MER data were manually selected using visual and auditory inspection. RESULTS: Six patients underwent bilateral DBS electrode implantation. In all patients, the target was the anterior internal globus pallidus. Patient comfort and hemodynamic and respiratory stability were maintained with conscious sedation with one or more of the following anesthetic drugs: propofol, midazolam, remifentanil, clonidine, and dexmedetomidine. Good quality MER and clinical testing were obtained in 9 hemispheres of 6 patients. In 3 patients, MER quality was poor on one side. CONCLUSION: Cautiously applied sedative drugs can provide patient comfort, hemodynamic and respiratory stability, and suppress severe tics, with minimal interference with MER.

Human Sensation of Transcranial Electric Stimulation.

Noninvasive transcranial electric stimulation is increasingly being used as an advantageous therapy alternative that may activate deep tissues while avoiding drug side-effects. However, not only is there limited evidence for activation of deep tissues by transcranial electric stimulation, its evoked human sensation is understudied and often dismissed as a placebo or secondary effect. By systematically characterizing the human sensation evoked by transcranial alternating-current stimulation, we observed not only stimulus frequency and electrode position dependencies specific for auditory and visual sensation but also a broader presence of somatic sensation ranging from touch and vibration to pain and pressure. We found generally monotonic input-output functions at suprathreshold levels, and often multiple types of sensation occurring simultaneously in response to the same electric stimulation. We further used a recording circuit embedded in a cochlear implant to directly and objectively measure the amount of transcranial electric stimulation reaching the auditory nerve, a deep intercranial target located in the densest bone of the skull. We found an optimal configuration using an ear canal electrode and low-frequency (<300 Hz) sinusoids that delivered maximally ~1% of the transcranial current to the auditory nerve, which was sufficient to produce sound sensation even in deafened ears. Our results suggest that frequency resonance due to neuronal intrinsic electric properties need to be explored for targeted deep brain stimulation and novel brain-computer interfaces.

Safety and Utility of Spinal Magnetic Resonance Imaging in Patients with High-Frequency Spinal Cord Stimulators: A Prospective Single-Centre Study.

BACKGROUND: Implanted high-frequency spinal cord stimulators at 10 kHz (HF-SCS) have recently acquired conditional approval for magnetic resonance imaging (MRI), including retrospective application to previously implanted devices. Under certain conditions, there are greater specific absorption rate (SAR) scanning restrictions compared to some conventional alternatives. This poses technical challenges to obtain diagnostic quality imaging. OBJECTIVES: To describe our experience with 9 such scans, demonstrating that safe and diagnostically useful images can be obtained despite these restrictions. METHODS: We report a prospective single-centre series of 9 scans within a tertiary neuroscience centre, all obtained within the required SAR limit of ≤0.4 W/kg, and describe the scanning protocol we have developed. We further illustrate this with 2 representative patient cases. RESULTS: The imaging studies were well tolerated without complication. In all cases, the imaging quality was sufficient for the reporting neuroradiologist to answer the clinical question posed. CONCLUSION: Despite technical challenges, MRI is feasible, safe and diagnostically useful in HF-SCS-implanted patients. We would invite other centres that implant these devices to consider the development of their own scanning protocols to avoid the morbidity and inconvenience of explantation or computed tomography myelography. To our knowledge, this is the first reported study of MRI in HF-SCS-implanted patients achieving the requisite SAR limit of ≤0.4 W/kg.

Chronic Implantation of Multiple Flexible Polymer Electrode Arrays.

Simultaneous recordings from large populations of individual neurons across distributed brain regions over months to years will enable new avenues of scientific and clinical development. The use of flexible polymer electrode arrays can support long-lasting recording, but the same mechanical properties that allow for longevity of recording make multiple insertions and integration into a chronic implant a challenge. Here is a methodology by which multiple polymer electrode arrays can be targeted to a relatively spatially unconstrained set of brain areas. The method utilizes thin-film polymer devices, selected for their biocompatibility and capability to achieve long-term and stable electrophysiologic recording interfaces. The resultant implant allows accurate and flexible targeting of anatomically distant regions, physical stability for months, and robustness to electrical noise. The methodology supports up to sixteen serially inserted devices across eight different anatomic targets. As previously demonstrated, the methodology is capable of recording from 1024 channels. Of these, the 512 channels in this demonstration used for single neuron recording yielded 375 single units distributed across six recording sites. Importantly, this method also can record single units for at least 160 days. This implantation strategy, including temporarily bracing each device with a retractable silicon insertion shuttle, involves tethering of devices at their target depths to a skull-adhered plastic base piece that is custom-designed for each set of recording targets, and stabilization/protection of the devices within a silicone-filled, custom-designed plastic case. Also covered is the preparation of devices for implantation, and design principles that should guide adaptation to different combinations of brain areas or array designs.