@article {4571, title = {Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial.}, journal = {PLoS One}, volume = {19}, year = {2024}, month = {2024}, pages = {e0301154}, abstract = {

BACKGROUND: Inflammation has been implicated in driving the morbidity associated with subarachnoid hemorrhage (SAH). Despite understanding the important role of inflammation in morbidity following SAH, there is no current effective way to modulate this deleterious response. There is a critical need for a novel approach to immunomodulation that can be safely, rapidly, and effectively deployed in SAH patients. Vagus nerve stimulation (VNS) provides a non-pharmacologic approach to immunomodulation, with prior studies demonstrating VNS can reduce systemic inflammatory markers, and VNS has had early success treating inflammatory conditions such as arthritis, sepsis, and inflammatory bowel diseases. The aim of the Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH) trial is to translate the use of non-invasive transcutaneous auricular VNS (taVNS) to spontaneous SAH, with our central hypothesis being that implementing taVNS in the acute period following spontaneous SAH attenuates the expected inflammatory response to hemorrhage and curtails morbidity associated with inflammatory-mediated clinical endpoints.

MATERIALS AND METHODS: The overall objectives for the NAHSaH trial are to 1) Define the impact that taVNS has on SAH-induced inflammatory markers in the plasma and cerebrospinal fluid (CSF), 2) Determine whether taVNS following SAH reduces radiographic vasospasm, and 3) Determine whether taVNS following SAH reduces chronic hydrocephalus. Following presentation to a single enrollment site, enrolled SAH patients are randomly assigned twice daily treatment with either taVNS or sham stimulation for the duration of their intensive care unit stay. Blood and CSF are drawn before initiation of treatment sessions, and then every three days during a patient{\textquoteright}s hospital stay. Primary endpoints include change in the inflammatory cytokine TNF-α in plasma and cerebrospinal fluid between day 1 and day 13, rate of radiographic vasospasm, and rate of requirement for long-term CSF diversion via a ventricular shunt. Secondary outcomes include exploratory analyses of a panel of additional cytokines, number and type of hospitalized acquired infections, duration of external ventricular drain in days, interventions required for vasospasm, continuous physiology data before, during, and after treatment sessions, hospital length of stay, intensive care unit length of stay, and modified Rankin Scale score (mRS) at admission, discharge, and each at follow-up appointment for up to two years following SAH.

DISCUSSION: Inflammation plays a central role in morbidity following SAH. This NAVSaH trial is innovative because it diverges from the pharmacologic status quo by harnessing a novel non-invasive neuromodulatory approach and its known anti-inflammatory effects to alter the pathophysiology of SAH. The investigation of a new, effective, and rapidly deployable intervention in SAH offers a new route to improve outcomes following SAH.

TRIAL REGISTRATION: Clinical Trials Registered, NCT04557618. Registered on September 21, 2020, and the first patient was enrolled on January 4, 2021.

}, keywords = {Adult, Female, Humans, Inflammation, Male, Middle Aged, Prospective Studies, Randomized Controlled Trials as Topic, Subarachnoid Hemorrhage, Treatment Outcome, Vagus Nerve Stimulation}, issn = {1932-6203}, doi = {10.1371/journal.pone.0301154}, author = {Huguenard, Anna and Tan, Gansheng and Johnson, Gabrielle and Adamek, Markus and Coxon, Andrew and Kummer, Terrance and Osbun, Joshua and Vellimana, Ananth and Limbrick, David and Zipfel, Gregory and Brunner, Peter and Leuthardt, Eric} } @article {3386, title = {A practical, intuitive brain-computer interface for communicating {\textquoteright}yes{\textquoteright} or {\textquoteright}no{\textquoteright} by listening.}, journal = {J Neural Eng}, volume = {11}, year = {2014}, month = {06/2014}, pages = {035003}, abstract = {OBJECTIVE: Previous work has shown that it is possible to build an EEG-based binary brain-computer interface system (BCI) driven purely by shifts of attention to auditory stimuli. However, previous studies used abrupt, abstract stimuli that are often perceived as harsh and unpleasant, and whose lack of inherent meaning may make the interface unintuitive and difficult for beginners. We aimed to establish whether we could transition to a system based on more natural, intuitive stimuli (spoken words {\textquoteright}yes{\textquoteright} and {\textquoteright}no{\textquoteright}) without loss of performance, and whether the system could be used by people in the locked-in state. APPROACH: We performed a counterbalanced, interleaved within-subject comparison between an auditory streaming BCI that used beep stimuli, and one that used word stimuli. Fourteen healthy volunteers performed two sessions each, on separate days. We also collected preliminary data from two subjects with advanced amyotrophic lateral sclerosis (ALS), who used the word-based system to answer a set of simple yes-no questions. MAIN RESULTS: The N1, N2 and P3 event-related potentials elicited by words varied more between subjects than those elicited by beeps. However, the difference between responses to attended and unattended stimuli was more consistent with words than beeps. Healthy subjects{\textquoteright} performance with word stimuli (mean 77\% {\textpm} 3.3 s.e.) was slightly but not significantly better than their performance with beep stimuli (mean 73\% {\textpm} 2.8 s.e.). The two subjects with ALS used the word-based BCI to answer questions with a level of accuracy similar to that of the healthy subjects. SIGNIFICANCE: Since performance using word stimuli was at least as good as performance using beeps, we recommend that auditory streaming BCI systems be built with word stimuli to make the system more pleasant and intuitive. Our preliminary data show that word-based streaming BCI is a promising tool for communication by people who are locked in.}, keywords = {Adult, Aged, Algorithms, Auditory Perception, brain-computer interfaces, Communication Aids for Disabled, Electroencephalography, Equipment Design, Equipment Failure Analysis, Female, Humans, Male, Man-Machine Systems, Middle Aged, Quadriplegia, Treatment Outcome, User-Computer Interface}, issn = {1741-2552}, doi = {10.1088/1741-2560/11/3/035003}, url = {http://www.ncbi.nlm.nih.gov/pubmed/24838278}, author = {Jeremy Jeremy Hill and Ricci, Erin and Haider, Sameah and McCane, Lynn M and Susan M Heckman and Jonathan Wolpaw and Theresa M Vaughan} } @article {2169, title = {Patients with ALS can use sensorimotor rhythms to operate a brain-computer interface.}, journal = {Neurology}, volume = {64}, year = {2005}, month = {05/2005}, pages = {1775-7}, abstract = {

People with severe motor disabilities can maintain an acceptable quality of life if they can communicate.\ Brain-computer interfaces\ (BCIs), which do not depend on muscle control, can provide communication. Four people severely disabled by ALS learned to operate a BCI with EEG rhythms recorded over sensorimotor cortex. These results suggest that a sensorimotor rhythm-based\ BCI could help maintain quality of life for people with ALS.

}, keywords = {Aged, Amyotrophic Lateral Sclerosis, Electroencephalography, Evoked Potentials, Motor, Evoked Potentials, Somatosensory, Female, Humans, Imagination, Male, Middle Aged, Motor Cortex, Movement, Paralysis, Photic Stimulation, Prostheses and Implants, Somatosensory Cortex, Treatment Outcome, User-Computer Interface}, issn = {1526-632X}, doi = {10.1212/01.WNL.0000158616.43002.6D}, url = {http://www.ncbi.nlm.nih.gov/pubmed/15911809}, author = {K{\"u}bler, A. and Nijboer, F and Mellinger, J{\"u}rgen and Theresa M Vaughan and Pawelzik, H and Gerwin Schalk and Dennis J. McFarland and Niels Birbaumer and Jonathan Wolpaw} } @article {3252, title = {Therapeutic neural effects of electrical stimulation.}, journal = {IEEE transactions on rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society}, volume = {4}, year = {1996}, month = {12/1996}, pages = {218{\textendash}230}, abstract = {The use of a functional neuromuscular stimulation (FNS) device can have therapeutic effects that persist when the device is not in use. Clinicians have reported changes in both voluntary and electrically assisted neuromuscular function and improvements in the condition of soft tissue. Motor recovery has been observed in people with incomplete spinal cord injury, stroke, or traumatic brain injury after the use of motor prostheses. Improvement in voluntary dorsiflexion and overall gait pattern has been reported both in the short term (several hours) and permanently. Electrical stimulation of skin over flexor muscles in the upper limb produced substantial reductions for up to 1 h in the severity of spasticity in brain-injured subjects, as measured by the change in torque generation during ramp-and-hold muscle stretch. There was typically an aggravation of the severity of spasticity when surface stimulation reached intensities sufficient to also excite muscle. Animals were trained to alter the size of the H-reflex to obtain a reward. The plasticity that underlies this operantly conditioned H-reflex change includes changes in the spinal cord itself. Comparable changes appear to occur with acquisition of certain motor skills. Current studies are exploring such changes in humans and animals with spinal cord injuries with the goal of using conditioning methods to assess function after injury and to promote and guide recovery of function. A better understanding of the mechanisms of neural plasticity, achieved through human and animal studies, may help us to design and implement FNS systems that have the potential to produce beneficial changes in the subject{\textquoteright}s central nervous systems.}, keywords = {Treatment Outcome}, issn = {1063-6528}, doi = {10.1109/86.547922}, url = {http://www.ncbi.nlm.nih.gov/pubmed/8973948}, author = {Janis J. Daly and Marsolais, E. B. and Mendell, L. M. and Rymer, W. Z. and Stefanovska, A. and Jonathan Wolpaw and Kantor, C.} }