Online speech synthesis using a chronically implanted brain-computer interface in an individual with ALS.

Brain-computer interfaces (BCIs) that reconstruct and synthesize speech using brain activity recorded with intracranial electrodes may pave the way toward novel communication interfaces for people who have lost their ability to speak, or who are at high risk of losing this ability, due to neurological disorders. Here, we report online synthesis of intelligible words using a chronically implanted brain-computer interface (BCI) in a man with impaired articulation due to ALS, participating in a clinical trial (ClinicalTrials.gov, NCT03567213) exploring different strategies for BCI communication. The 3-stage approach reported here relies on recurrent neural networks to identify, decode and synthesize speech from electrocorticographic (ECoG) signals acquired across motor, premotor and somatosensory cortices. We demonstrate a reliable BCI that synthesizes commands freely chosen and spoken by the participant from a vocabulary of 6 keywords previously used for decoding commands to control a communication board. Evaluation of the intelligibility of the synthesized speech indicates that 80% of the words can be correctly recognized by human listeners. Our results show that a speech-impaired individual with ALS can use a chronically implanted BCI to reliably produce synthesized words while preserving the participant's voice profile, and provide further evidence for the stability of ECoG for speech-based BCIs.

The Shunt Valve Recession Technique as a Neuroplastic Surgery Adjunct in Complex and High-Risk Shunt Revisions: Technical Note and Case Series.

BACKGROUND AND OBJECTIVES: Ventricular shunting is one of the most common procedures in neurosurgery. However, complications and revisions are frequent. Patients requiring multiple revisions often suffer secondary issues with scalp healing over hardware. Many common ventricular shunt valves have an obligate thickness that creates a visible protrusion and can potentially cause local tissue ischemia and breakdown in the setting of repeated surgery. The authors present a simple technique for recessing the shunt valve into the underlying bone to alleviate protrusion in high-risk cases. Three example cases utilizing this technique are presented. METHODS: The skull directly underlying the planned valve site is uniformly recessed with a cutting burr several millimeters as desired while maintaining the inner cortical bone layer. The valve is fixed with standard cranial plating hardware. EXPECTED OUTCOMES: Three patients are reported who underwent shunt valve recession as an adjunct to their shunt revision with neuroplastic surgery assistance. All patients had undergone multiple prior surgeries that had resulted in thin and high-risk fragile scalp. In 1 patient, the prior valve was eroding through the scalp before the described revision. All patients had satisfactory cosmetic outcomes, and there were no revisions in the 2-month follow-up period. DISCUSSION: Complex and high-risk ventricular shunt patients should be considered for shunt valve recession into the bone to reduce wound-related complications and enhance healing. This is a technically simple, safe, and effective technique to include as a neuroplastic adjunct.

Skull and Scalp En-Bloc Harvest Protects Calvarial Perfusion: A Cadaveric Study.

BACKGROUND: Calvarial defects are severe injuries that can result from a wide array of etiologies. Reconstructive modalities for these clinical challenges include autologous bone grafting or cranioplasty with biocompatible alloplastic materials. Unfortunately, both approaches are limited by factors such as donor site morbidly, tissue availability, and infection. Calvarial transplantation offers the potential opportunity to address skull defect form and functional needs by replacing "like-with-like" tissue but remains poorly investigated. METHODS: Three adult human cadavers underwent circumferential dissection and osteotomy to raise the entire scalp and skull en-bloc. The vascular pedicles of the scalp were assessed for patency and perfused with color dye, iohexol contrast agent for computed tomography (CT) angiography, and indocyanine green for SPY-Portable Handheld Imager assessment of perfusion to the skull. RESULTS: Gross changes were appreciated to the scalp with color dye, but not to bone. CT angiography and SPY-Portable Handheld Imager assessment confirmed perfusion from the vessels of the scalp to the skull beyond midline. CONCLUSION: Calvarial transplantation may be a technically viable option for skull defect reconstruction that requires vascularized composite tissues (bone and soft tissue) for optimal outcomes.

Skull and Scalp En-Bloc Harvest Protects Calvarial Perfusion: A Cadaveric Study.

BACKGROUND: Calvarial defects are severe injuries that can result from a wide array of etiologies. Reconstructive modalities for these clinical challenges include autologous bone grafting or cranioplasty with biocompatible alloplastic materials. Unfortunately, both approaches are limited by factors such as donor site morbidly, tissue availability, and infection. Calvarial transplantation offers the potential opportunity to address skull defect form and functional needs by replacing "like-with-like" tissue but remains poorly investigated. METHODS: Three adult human cadavers underwent circumferential dissection and osteotomy to raise the entire scalp and skull en-bloc. The vascular pedicles of the scalp were assessed for patency and perfused with color dye, iohexol contrast agent for computed tomography (CT) angiography, and indocyanine green for SPY-Portable Handheld Imager assessment of perfusion to the skull. RESULTS: Gross changes were appreciated to the scalp with color dye, but not to bone. CT angiography and SPY-Portable Handheld Imager assessment confirmed perfusion from the vessels of the scalp to the skull beyond midline. DISCUSSION/CONCLUSION: Calvarial transplantation may be a technically viable option for skull defect reconstruction that requires vascularized composite tissues (bone and soft tissue) for optimal outcomes.

Online speech synthesis using a chronically implanted brain-computer interface in an individual with ALS.

Recent studies have shown that speech can be reconstructed and synthesized using only brain activity recorded with intracranial electrodes, but until now this has only been done using retrospective analyses of recordings from able-bodied patients temporarily implanted with electrodes for epilepsy surgery. Here, we report online synthesis of intelligible words using a chronically implanted brain-computer interface (BCI) in a clinical trial participant (ClinicalTrials.gov, NCT03567213) with dysarthria due to amyotrophic lateral sclerosis (ALS). We demonstrate a reliable BCI that synthesizes commands freely chosen and spoken by the user from a vocabulary of 6 keywords originally designed to allow intuitive selection of items on a communication board. Our results show for the first time that a speech-impaired individual with ALS can use a chronically implanted BCI to reliably produce synthesized words that are intelligible to human listeners while preserving the participants voice profile.

Discussion on: "Let's Smarten Up: Smart Devices and the Internet of Things, an Untapped Resource for Innovation in Craniofacial Surgery".

Prior to Dr. Paul Tessier's teachings in the 1960's, many neurosurgeons and craniofacial surgeons took shortcuts and employed alloplastic materials fraught with complication, and soon thereafter, both surgical specialties moved the pendulum towards the side of bone grafts being the gold standard for neurosurgical reconstruction and the art of cranioplasty. But now half a century later, neuroplastic surgery is moving the pendulum the other way. Without a doubt, the brain is a critical organ that needs some form of modulation as opposed to replacement. The intervention delivered can be in the form of electricity, light, medicine, etc. Regardless of the medium, it needs to be housed somewhere. And there is no better real estate than to be housed within a sterile alloplastic case with embedded smart technologies; in a way that prevents obvious, visual deformity. For example, it would be naïve to think that the future of embedded neurotechnologies will one day be housed safely and dependably within one's own bone flap. Hence, moving forward, time-tested alloplastic materials will become the new gold standard for cranioplasty reconstruction as the world starts to welcome a generation of smart cranial devices; some of which may house Bluetooth-connected, Wifi-enabled, MRI-compatible pumps to perform convection-enhanced delivery of time-tested medicines - thereby forever changing the way we approach chronic neurological disease and the forever-obstructing, blood-brain barrier. As this happens, I feel confident saying that both Tessier and Cushing are somewhere applauding and smiling on these efforts.

Cranioplasty Outcomes From 500 Consecutive Neuroplastic Surgery Patients.

BACKGROUND: Cranioplasty is critical to cerebral protection and restoring intracranial physiology, yet this procedure is fraught with a high risk of complications. The field of neuroplastic surgery was created to improve skull and scalp reconstruction outcomes in adult neurosurgical patients, with the hypothesis that a multidisciplinary team approach could help decrease complications. OBJECTIVE: To determine outcomes from a cohort of cranioplasty surgeries performed by a neuroplastic surgery team using a consistent surgical technique and approach. METHODS: The authors reviewed 500 consecutive adult neuroplastic surgery cranioplasties that were performed between January 2012 and September 2020. Data were abstracted from a prospectively maintained database. Univariate analysis was performed to determine association between demographic, medical, and surgical factors and odds of revision surgery. RESULTS: Patients were followed for an average of 24 months. Overall, there was a reoperation rate of 15.2% (n = 76), with the most frequent complications being infection (7.8%, n = 39), epidural hematoma (2.2%, n = 11), and wound dehiscence (1.8%, n = 9). New onset seizures occurred in 6 (1.2%) patients.Several variables were associated with increased odds of revision surgery, including lower body mass ratio, 2 or more cranial surgeries, presence of hydrocephalus shunts, scalp tissue defects, large-sized skull defect, and autologous bone flaps. importantly, implants with embedded neurotechnology were not associated with increased odds of reoperation. CONCLUSIONS: These results allow for comparison of multiple factors that impact risk of complications after cranioplasty and lay the foundation for development of a cranioplasty risk stratification scheme. Further research in neuroplastic surgery is warranted to examine how designated centers concentrating on adult neuro-cranial reconstruction and multidisciplinary collaboration may lead to improved cranioplasty outcomes and decreased risks of complications in neurosurgical patients.

The Impact of Hydrocephalus Shunt Devices on Quality of Life.

BACKGROUND: Despite advances in hydrocephalus shunt technology and improvement in hydrocephalus management, many patients have chronic disability and require multiple surgeries throughout their lifetime. There is limited data from patients' perspective regarding the impact of shunt devices on quality-of-life. METHODS: A cross-sectional survey was developed to evaluate the impact of shunt devices on patient quality-of-life. The survey was distributed via social media platforms of the Hydrocephalus Association, and patients self-selected to anonymously complete the online questionnaire. A literature review was performed to contextualize the findings from the survey. RESULTS: A total of 562 survey responses were obtained from a network encompassing 35,000 members. The mean age was 30 years old (0.5-87), and 65% identified as female. Eighty one percent underwent at least 1 shunt revision surgery, with a reported average of 10 shunt revision surgeries per patient (1-200 surgeries). Occlusion, shunt migration and infection were the leading causes for revision at 60%, 47%, and 35%, respectively. In addition, 72% of patients reported pain and discomfort from the device, and 68% expressed avoidance of certain activities due to "fear of bumping shunt." Despite numerous articles discussing shunt technology, a review of the literature indicated a paucity of studies specifically evaluating the burden of shunt devices from a patient/caregiver perspective. CONCLUSIONS: The findings from this study suggest long-term physical and psychosocial burden associated with shunt devices. Importantly, this study highlights the need for concerted efforts to develop validated tools to study patient reported outcomes as it relates to neurocranial implanted devices.

Novel intraoperative online functional mapping of somatosensory finger representations for targeted stimulating electrode placement: technical note.

Defining eloquent cortex intraoperatively, traditionally performed by neurosurgeons to preserve patient function, can now help target electrode implantation for restoring function. Brain-machine interfaces (BMIs) have the potential to restore upper-limb motor control to paralyzed patients but require accurate placement of recording and stimulating electrodes to enable functional control of a prosthetic limb. Beyond motor decoding from recording arrays, precise placement of stimulating electrodes in cortical areas associated with finger and fingertip sensations allows for the delivery of sensory feedback that could improve dexterous control of prosthetic hands. In this study, the authors demonstrated the use of a novel intraoperative online functional mapping (OFM) technique with high-density electrocorticography to localize finger representations in human primary somatosensory cortex. In conjunction with traditional pre- and intraoperative targeting approaches, this technique enabled accurate implantation of stimulating microelectrodes, which was confirmed by postimplantation intracortical stimulation of finger and fingertip sensations. This work demonstrates the utility of intraoperative OFM and will inform future studies of closed-loop BMIs in humans.

First-In-Human Experience With Integration of Wireless Intracranial Pressure Monitoring Device Within a Customized Cranial Implant.

BACKGROUND: Decompressive craniectomy is a lifesaving treatment for intractable intracranial hypertension. For patients who survive, a second surgery for cranial reconstruction (cranioplasty) is required. The effect of cranioplasty on intracranial pressure (ICP) is unknown. OBJECTIVE: To integrate the recently Food and Drug Administration-approved, fully implantable, noninvasive ICP sensor within a customized cranial implant (CCI) for postoperative monitoring in patients at high risk for intracranial hypertension. METHODS: A 16-yr-old female presented for cranioplasty 4-mo after decompressive hemicraniectomy for craniocerebral gunshot wound. Given the persistent transcranial herniation with concomitant subdural hygroma, there was concern for intracranial hypertension following cranioplasty. Thus, cranial reconstruction was performed utilizing a CCI with an integrated wireless ICP sensor, and noninvasive postoperative monitoring was performed. RESULTS: Intermittent ICP measurements were obtained twice daily using a wireless, handheld monitor. The ICP ranged from 2 to 10 mmHg in the supine position and from -5 to 4 mmHg in the sitting position. Interestingly, an average of 7 mmHg difference was consistently noted between the sitting and supine measurements. CONCLUSION: This first-in-human experience demonstrates several notable findings, including (1) newfound safety and efficacy of integrating a wireless ICP sensor within a CCI for perioperative neuromonitoring; (2) proven restoration of normal ICP postcranioplasty despite severe preoperative transcranial herniation; and (3) proven restoration of postural ICP adaptations following cranioplasty. To the best of our knowledge, this is the first case demonstrating these intriguing findings with the potential to fundamentally alter the paradigm of cranial reconstruction.

Risk of Complications in Primary Versus Revision-Type Cranioplasty.

INTRODUCTION: Cranioplasty (CP) is a multifaceted procedure in a heterogenous patient population, with a high risk for complication. However, no previous large-scale studies have compared outcomes in primary (ie, first attempt) CP versus revision CP (ie, following previous attempts). The authors, therefore, analyzed long-term outcomes of 506 consecutive primary and revision CPs, performed by a single surgeon. METHODS: All CPs performed between 2012 and 2019 were analyzed under IRB protocol approval. Surgeries were categorized as either primary (no previous CP; n = 279) or revision CP (at least one previous CP; n = 227). Complications were defined as either major or minor. Subgroup analyses investigated whether or not CP complication risk directly correlated with the number of previous neuro-cranial surgeries and/or CP attempts. RESULTS: The primary CP group experienced a major complication rate of 9% (26/279). In comparison, the revision CP group demonstrated a major complication rate of 32% (73/227). For the revision CP group, the rate of major complications rose with each additional surgery, from 4% (1 prior surgery) to 17% (2 prior surgeries) to 39% (3-4 prior surgeries) to 47% (≥5 prior surgeries). CONCLUSION: In a review of 506 consecutive cases, patients undergoing revision CP had a 3-fold increase in incidence of major complications, as compared to those undergoing primary CP. These results provide critical insight into overall CP risk stratification and may guide preoperative risk-benefit discussions. Furthermore, these findings may support a center-of-excellence care model, particularly for those patients with a history of previous neuro-cranial surgeries and/or CP attempts.

Sonolucent Cranial Implants: Cadaveric Study and Clinical Findings Supporting Diagnostic and Therapeutic Transcranioplasty Ultrasound.

BACKGROUND: Previously, sonographic evaluation of the intracranial contents was limited to intraoperative use following bone flap removal, with placement of the probe directly on the cortical surface or through a transsulcal tubular retractor. Cranioplasty with sonolucent implants may represent a postoperative window into the brain by allowing ultrasound to serve as a novel bedside imaging modality. The potential sonolucency of various commonly used cranial implant types was examined in this study. METHODS: A 3-phase study was comprised of cadaveric evaluation of transcranioplasty ultrasound (TCU) with cranioplasty implants of varying materials, intraoperative TCU during right-sided cranioplasty with clear implant made of poly-methyl-methacrylate (PMMA), and bedside TCU on postoperative day 5 after cranioplasty. RESULTS: The TCU through clear PMMA, polyether-ether-ketone, and opaque PMMA cranial implants revealed implant sonoluceny, in contrast to autologous bone and porous-polyethylene. Intraoperative ultrasound via the clear PMMA implant in a single patient revealed recognizable ventricular anatomy. Furthermore, postoperative bedside ultrasound in the same patient revealed comparable ventricular anatomy and a small epidural fluid collection corresponding to that visualized on an axial computed tomography scan. CONCLUSION: Sonolucent cranial implants, such as those made of clear PMMA, hold great promise for enhanced diagnostic and therapeutic applications previously limited by cranial bone. Furthermore, as functional cranial implants are manufactured with implantable devices housed within clear PMMA, the possibility of utilizing ultrasound for real-time surveillance of intracranial pathology becomes much more feasible.

First-in-Human Experience With Integration of a Hydrocephalus Shunt Device Within a Customized Cranial Implant.

BACKGROUND: Implantable shunt devices are critical and life saving for hydrocephalus patients. However, these devices are fraught with high complication rates including scalp dehiscence, exposure, and extrusion. In fact, high shunt valve profiles are correlated with increased complications compared to those with lower profiles. As such, we sought a new method for integrating shunt valves for those challenging patients presenting with scalp-related complications. OBJECTIVE: To safely implant and integrate a hydrocephalus shunt valve device within a customized cranial implant, in an effort to limit its high-profile nature as a main contributor to shunt failure and scalp breakdown, and at the same time, improve patient satisfaction by preventing contour deformity. METHODS: A 64-yr-old male presented with an extruding hydrocephalus shunt valve and chronic, open scalp wound. The shunt valve was removed and temporary shunt externalization was performed. He received 2 wk of culture-directed antibiotics. Next, a contralateral craniectomy was performed allowing a new shunt valve system to be implanted within a low-profile, customized cranial implant. All efforts were made, at the patient's request, to decrease the high-profile nature of the shunt valve contributing to his most recent complication. RESULTS: First-in-human implantation was performed without complication. Postoperative shunt identification and programming was uncomplicated. The high-profile nature of the shunt valve was decreased by 87%. At 10 mo, the patient has experienced no complications and is extremely satisfied with his appearance. CONCLUSION: This first-in-human experience suggests that a high-profile hydrocephalus shunt device may be safely integrated within a customized cranial implant.

Full-Thickness Skin Grafting for Local Defect Coverage Following Scalp Adjacent Tissue Transfer in the Setting of Cranioplasty.

INTRODUCTION: Numerous techniques have been described to overcome scalp deficiency and high-tension closure at time of cranioplasty. However, there is an existing controversy, over when and if a free flap is needed during complex skull reconstruction (ie, cranioplasty). As such the authors present here our experience using full-thickness skin grafts (FTSGs) to cover local defects following scalp adjacent tissue transfer in the setting of cranioplasty. METHODS: By way of an institutional review board-approved database, the authors identified patients treated over a 3-year period spanning January 2015 to December 2017, who underwent scalp reconstruction using the technique presented here. Patient demographics, clinical characteristics, technical details, outcomes, and long-term follow up were statistically analyzed for the purpose of this study. RESULTS: Thirty-three patients, who underwent combined cranioplasty and scalp reconstruction using an FTSG for local donor site coverage, were identified. Twenty-five (75%) patients were considered to have "high complexity" scalp defects prior to reconstruction. Of them, 12 patients (36%) were large-sized and 20 (60%) medium-sized; 21 (64%) grafts were inset over vascularized muscle or pericranium while the remaining grafts were placed over bare calvarial bone. In total, the authors found 94% (31/33) success for all FTSGs in this cohort. Two of the skin grafts failed due to unsuccessful take. Owing to the high rate of success in this series, none of the patient's risk factors were found to correlate with graft failure. In addition, the success rate did not differ whether the graft was placed over bone verses over vascularized muscle/pericranium. CONCLUSION: In contrary to previous studies that have reported inconsistent success with full-thickness skin grafting in this setting, the authors present a simple technique with consistent results-as compared to other more complex reconstructive methods-even in the setting of highly complex scalp reconstruction and simultaneous cranioplasty.

Dural Reconstruction With Autologous Rectus Fascia: A New Technique for Addressing Large-Sized Defects During Cranioplasty.

INTRODUCTION: Patients requiring cranioplasty reconstruction with customized cranial implants may unexpectedly present with cerebrospinal fluid (CSF) leaks and durotomies following previous neurosurgical procedures. As such, multiple factors influence the type of dural reconstruction chosen at this time, which are essential for achieving long-term success. Overall, the most common material used for duraplasty is currently an "off-the-shelf" xenograft construct. However, some believe that they are not suitable for large-sized defects and accompany a higher incident of complications. Therefore, based on our success and experience with scalp augmentation using rectus fascia grafts, the authors herein present our preliminary experience with duraplasty using autologous rectus fascia grafts (ARFGs). METHODS: A retrospective review of our database, consisting of 437 cranial reconstructions from 2012 to 2017, was performed under institutional review board approval. Selection criteria included all adult patients (n = 6) requiring dural reconstruction (duraplasty) with ARF grafting for an active CFS leak with concomitant skull defect. Cadaver study and patient illustrations are also presented to demonstrate clinical applicability. All outcomes, including complications, were reviewed and are presented here. RESULTS: A total of 6 patients underwent autologous duraplasty with either unilateral or bilateral ARFGs. All patients (6/6) of large-sized (>3 cm) defect repair with ARFGs were indicated for repair of secondary CSF leaks following previous craniotomy by neurosurgery. To date, none have demonstrated recurrent leaking and/or dura-related complications. At this time, all 6 patients were reconstructed using customized cranial implants with a mean follow-up of 10 months. CONCLUSION: Based on our preliminary experience presented here, the use of rectus fascia grafts for autologous dural reconstruction appears to be both safe and reliable. This new technique adds another tool to the neurosurgical armamentarium by reducing the additional risk of "off-the-shelf" dural substitutes.