Nuclear Drugs

Drs. Theodoros Zanos and Jamie Hirsch, MD, have helped develop an algorithm that predicts a hospitalized patient’s overnight stability, and if they could be left uninterrupted overnight to sleep.

Modulation of the peripheral nervous system (PNS) has a great potential for therapeutic intervention as well as restore bodily functions. Recent interest has focused on autonomic nerves, as they regulate extensive functions implicated in organ physiology, chronic disease state and appear tractable to targeted modulation of discrete nerve units. Therapeutic interventions based on specific bioelectronic neuromodulation depend on reliable neural interface to stimulate and record autonomic nerves. Furthermore, the function of stimulation and recording requires energy which should be delivered to the interface. Due to the physiological and anatomical challenges of autonomic nerves, various forms of this active neural interface need to be developed to achieve next generation of neural interface for bioelectronic medicine. In this article, we present an overview of the state-of-the-art for peripheral neural interface technology in relation to autonomic nerves. Also, we reveal the current status of wireless neural interface for peripheral nerve applications. Recent studies of a novel concept of self-sustainable neural interface without battery and electronic components are presented. Finally, the recent results of non-invasive stimulation such as ultrasound and magnetic stimulation are covered and the perspective of the future research direction is provided.

Background Understanding the long-term behavior of intracortically-recorded signals is essential for improving the performance of Brain Computer Interfaces. However, few studies have systematically investigated chronic neural recordings from an implanted microelectrode array in the human brain. Methods In this study, we show the applicability of wavelet decomposition method to extract and demonstrate the utility of long-term stable features in neural signals obtained from a microelectrode array implanted in the motor cortex of a human with tetraplegia. Wavelet decomposition was applied to the raw voltage data to generate mean wavelet power (MWP) features, which were further divided into three sub-frequency bands, low-frequency MWP (lf-MWP, 0–234 Hz), mid-frequency MWP (mf-MWP, 234 Hz–3.75 kHz) and high-frequency MWP (hf-MWP, >3.75 kHz). We analyzed these features using data collected from two experiments that were repeated over the course of about 3 years and compared their signal stability and decoding performance with the more standard threshold crossings, local field potentials (LFP), multi-unit activity (MUA) features obtained from the raw voltage recordings. Results All neural features could stably track neural information for over 3 years post-implantation and were less prone to signal degradation compared to threshold crossings. Furthermore, when used as an input to support vector machine based decoding algorithms, the mf-MWP and MUA demonstrated significantly better performance, respectively, in classifying imagined motor tasks than using the lf-MWP, hf-MWP, LFP, or threshold crossings. Conclusions Our results suggest that using MWP features in the appropriate frequency bands can provide an effective neural feature for brain computer interface intended for chronic applications. Trial registration This study was approved by the U.S. Food and Drug Administration (Investigational Device Exemption) and the Ohio State University Medical Center Institutional Review Board (Columbus, Ohio). The study conformed to institutional requirements for the conduct of human subjects and was filed on ClinicalTrials.gov (Identifier NCT01997125 ).

Introducing neural sensing and decoding to open-loop neurostimulation technologies has the potential to significantly improve the diagnosis and treatment of a wide variety of diseases treated through bioelectronic medicine. Chronically implanted multi-electrode arrays (MEA) can be used for such neural sensing and are critical for obtaining data of high spatial and temporal resolution to provide accurate decoding. Signals recorded from these arrays include local field potentials (LFP), and multiunit (MU) and single-unit (SU) activity. LFP offer signal stability over time, but at the expense of decreased spatial resolution. SU activity, on the other hand, offers better spatial resolution, but is considered less stable in chronic applications. MU activity, which represents an aggregate spiking activity of a population of neurons on the order of several hundred microns away from the recording tip, is considered a signal that can offer a compromise between the two signals. Here we used a wavelet decomposition method to extract and characterize the LFP, MU and SU signals obtained from a 96-channel MEA implanted in the motor cortex of a nonhuman primate over a 7.5-month period. We observed that not only are the MU signals more stable over time compared with SU activity, but that they are also significantly less correlated among electrodes compared with LFP over the spatial scale of the implanted array. Histological analysis of tissue sections also revealed a 51% reduction in the number of neuronal cell bodies within a radius around the electrode tips of the implanted tissue compared with control tissue. Our results indicate that MU activity offers long-term signal stability with less correlated signals, potentially providing an effective signal for neural sensing in bioelectronic medicine.

Neurosurgeon and immunologist Kevin Tracey shares the frontiers of a new, hybrid field - bioelectronic medicine.

Pharmacoresistance and adverse drug events designate a considerable group of patients with focal epilepsies that require alternative treatments such as neurosurgical intervention and neurostimulation. Electrical or magnetic stimulations of cortical brain areas for the treatment of pharmacoresistant focal epilepsies emerged from preclinical studies and experience through intraoperative neurophysiological monitoring in patients. Direct neurostimulation of seizure onset zones in neocortical brain areas may specifically affect neuronal networks involved in epileptiform activity without remarkable adverse influence on physiological cortical processing in immediate vicinity. Noninvasive low-frequency transcranial magnetic stimulation and cathodal transcranial direct current stimulation are suggested to be anticonvulsant; however, potential effects are ephemeral and require effect maintenance by ongoing stimulation. Invasive responsive neurostimulation, chronic subthreshold cortical stimulation, and epicranial cortical stimulation cover a broad range of different emerging technologies with intracranial and epicranial approaches that still have limited market access partly due to ongoing clinical development. Despite significant differences, the present bioelectronic technologies share common mode of actions with acute seizure termination by high-frequency stimulation and long-term depression induced by low-frequency magnetic or electrical stimulation or transcranial direct current stimulation.

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“No prescriptions, no medicines, no injections. That’s the future. That’s what gets me out of bed in the morning.” Kevin Tracey, MD. Dysautonomia International really scored when they got Kevin Tracey MD to be the keynote speaker at their 2020 Virtual Conference. He’s not involved in dysautonomia and knows nothing […]

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Neurosurgeon and immunologist Kevin Tracey shares the frontiers of a new, hybrid field - bioelectronic medicine.

Drs. Theodoros Zanos and Jamie Hirsch, MD, have helped develop an algorithm that predicts a hospitalized patient’s overnight stability, and if they could be left uninterrupted overnight to sleep.

Feinstein Institutes’ researchers publish in PNAS new avenue of bioelectronic nerve stimulation to control human body inflammation.

Cardiac arrest (CA) is a leading cause of death and there is a necessity for animal models that accurately represent human injury severity. We evaluated a rat model of severe CA injury by comparing plasma metabolic alterations to human patients. Plasma was obtained from adult human control and CA patients post-resuscitation, and from male Sprague–Dawley rats at baseline and after 20 min CA followed by 30 min cardiopulmonary bypass resuscitation. An untargeted metabolomics evaluation using UPLC-QTOF-MS/MS was performed for plasma metabolome comparison. Here we show the metabolic commonality ...

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Brain stimulation technology has become a viable modality of reversible interventions in the effective treatment of many neurological and psychiatric disorders. It is aimed to restore brain dysfunction by the targeted delivery of specific electronic signal within or outside the brain to modulate neural activity on local and circuit levels. Development of therapeutic approaches with brain stimulation goes in tandem with the use of neuroimaging methodology in every step of the way. Indeed, multimodality neuroimaging tools have played important roles in target identification, neurosurgical pla...

Background Vagus Nerve Stimulation (VNS) delivers Autonomic Regulation Therapy (ART) for heart failure (HF), and has been associated with improvement in cardiac function and heart failure symptoms. VNS is delivered using an implantable pulse generator (IPG) and lead with electrodes placed around the cervical vagus nerve. Because HF patients may receive concomitant cardiac defibrillation therapy, testing was conducted to determine the effect of defibrillation (DF) on the VNS system. Methods DF testing was conducted on three ART IPGs (LivaNova USA, Inc.) according to international standard IS...

The desire to harness electricity for improving human health dates back at least two millennia. As electrical signals form the basis of communication within our nervous system, the ability to monitor, control, and precisely deliver electricity within our bodies holds great promise for treating disease. The nascent field of bioelectronic medicine capitalizes on this approach to improve human health, however, challenges remain in relating electrical nerve activity to physiological function. To overcome these challenges, we need more long-term studies on neural circuits where the nerve activit...

When nerves are damaged by trauma or disease, they are still capable of firing off electrical command signals that originate from the brain. Furthermore, those damaged nerves have an innate ability to partially regenerate, so they can heal from trauma and even reinnervate new muscle targets. For an amputee who has his/her damaged nerves surgically reconstructed, the electrical signals that are generated by the reinnervated muscle tissue can be sensed and interpreted with bioelectronics to control assistive devices or robotic prostheses. No two amputees will have identical physiologies becau...

Modulation of the peripheral nervous system (PNS) has a great potential for therapeutic intervention as well as restore bodily functions. Recent interest has focused on autonomic nerves, as they regulate extensive functions implicated in organ physiology, chronic disease state and appear tractable to targeted modulation of discrete nerve units. Therapeutic interventions based on specific bioelectronic neuromodulation depend on reliable neural interface to stimulate and record autonomic nerves. Furthermore, the function of stimulation and recording requires energy which should be delivered t...

Pharmacoresistance and adverse drug events designate a considerable group of patients with focal epilepsies that require alternative treatments such as neurosurgical intervention and neurostimulation. Electrical or magnetic stimulations of cortical brain areas for the treatment of pharmacoresistant focal epilepsies emerged from preclinical studies and experience through intraoperative neurophysiological monitoring in patients. Direct neurostimulation of seizure onset zones in neocortical brain areas may specifically affect neuronal networks involved in epileptiform activity without remarkab...