Randomized Cross Over Study Assessing the Efficacy of Non-invasive Stimulation of the Vagus Nerve in Patients With Axial Spondyloarthritis Resistant to Biotherapies: The ESNV-SPA Study Protocol.

Axial spondyloarthritis (SpA), is a major cause of chronic pain and disability that profoundly alters the quality of life of patients. Nearly half of patients with SpA usually develop drug resistance. Non-pharmacological treatments targeting inflammation are an attractive alternative to drug administration. Vagus nerve stimulation (VNS), by promoting a cholinergic anti-inflammatory reflex holds promise for treating inflammatory disease. Inflammatory reflex signaling, which is enhanced by electrically stimulating the vagus nerve, significantly reduces cytokine production and attenuates disease severity in animal models of endotoxemia, sepsis, colitis, and other preclinical models of inflammatory diseases. It has been proposed that vagal efferent fibers release acetylcholine (Ach), which can interact with α7-subunit-containing nicotinic receptors expressed by tissue macrophages and other immune cells to rapidly inhibit the synthesis/release of pro-inflammatory cytokines such as TNFα, IL-1ß, IL-6, and IL-18. External vagal nerve stimulation devices are now available that do not require surgery nor implantation to non-invasively stimulate the vagal nerve. This double-blind randomized cross-over clinical trial aims to study the change in SpA disease activity, according to Assessment in Ankylosing Spondylitis 20 (ASAS20) definition, after 12 weeks of non-invasive VNS treatment vs. non-specific dummy stimulation (control group). One hundred and twenty adult patients with drug resistant SpA, meeting the ASAS classification criteria, will be included in the study. Patients will be randomized into two parallel groups according to a cross over design: either active VNS for 12 weeks, then dummy stimulation for 12 weeks, or dummy stimulation for 12 weeks, then active VNS for 12 weeks. The two stimulation periods will be separated by a 4 weeks wash-out period. A transcutaneous auricular vagus nerve stimulator Tens Eco Plus SCHWA MEDICOTM France will be used in this study. The active VNS stimulation will be applied in the cymba conchae of the left ear upon the auricular branch of the vagus nerve, using low intensity (2-5 mA), once à week, during 1 h. Dummy stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at an irrelevant anatomical site: the left ear lobule. This multicenter study was registered on ClinicalTrials.gov: NCT04286373.

Predicting intraoperative feasibility of combined TES-mMEP and cSSEP monitoring during scoliosis surgery based on preoperative neurophysiological assessment.

BACKGROUND CONTEXT: Combined monitoring of muscle motor evoked potentials elicited by transcranial electric stimulation (TES-mMEP) and cortical somatosensory evoked potentials (cSSEPs) is safe and effective for spinal cord monitoring during scoliosis surgery. However, TES-mMEP/cSSEP is not always feasible. Predictors of feasibility would help to plan the monitoring strategy. PURPOSE: To identify predictors of the feasibility of TES-mMEP/cSSEP during scoliosis surgery. STUDY DESIGN/SETTING: Prospective cohort study in a clinical neurophysiology unit and pediatric orthopedic department of a French university hospital. PATIENT SAMPLE: A total of 103 children aged 2 to 19 years scheduled for scoliosis surgery. OUTCOME MEASURES: Feasibility rate of intraoperative TES-mMEP/cSSEP monitoring. METHODS: All patients underwent a preoperative neurological evaluation and preoperative mMEP and cSSEP recordings at both legs. For each factor associated with feasibility, we computed sensitivity, specificity, positive predictive value (PPV), and negative predictive value. A decision tree was designed. RESULTS: Presence of any of the following factors was associated with 100% feasibility, 100% specificity, and 100% PPV: idiopathic scoliosis, normal preoperative neurological findings, and normal preoperative mMEP and cSSEP recordings. Feasibility was 0% in the eight patients with no recordable mMEPs or cSSEPs during preoperative testing. A decision tree involving three screening steps can be used to identify patients in whom intraoperative TES-mMEP/cSSEP is feasible. CONCLUSIONS: Preoperative neurological and neurophysiological assessments are helpful for identifying patients who can be successfully monitored by TES-mMEP/cSSEP during scoliosis surgery.

Chronic pseudo-angina left precordial chest pain caused by a thoracic meningioma.

Left precordial chest pain (LPCP) evokes above all angina. Eliminating a cardiac origin is then always the first priority. When cardiac causes are eliminated, non-cardiac causes are sought in order to avoid leaving patients with undiagnosed or undifferentiated chest pain. There is a myriad of non-cardiac causes ranging from heartburn, panic attacks, pleurisy, pulmonary embolism, pneumothorax, Tietze syndrome, bruises and fractures of the ribs, to spine meningioma, neuroma, herniated disk and impairment of the nerve roots. Although clinical presentation and characteristics of the pain are usually helpful in diagnosing the cause, conducting magnetic resonance imaging of the spine may be of a high utility in some situations. Here we report a case of chronic angina-like LPCP, caused by a thoracic meningioma. .

Pattern of brain injury in the acute setting of human septic shock.

BACKGROUND: Sepsis-associated brain dysfunction has been linked to white matter lesions (leukoencephalopathy) and ischemic stroke. Our objective was to assess the prevalence of brain lesions in septic shock patients requiring magnetic resonance imaging (MRI) for an acute neurologic change. METHOD: Seventy-one septic shock patients were included in a prospective observational study. Patients underwent daily neurological examination. Brain MRI was obtained in patients who developed focal neurological deficit, seizure, coma, or delirium. Electroencephalogy was performed in case of coma, delirium, or seizure. Leukoencephalopathy was graded and considered present when white matter lesions were either confluent or diffuse. Patient outcome was evaluated at 6 months with the Glasgow Outcome Scale (GOS). RESULTS: We included 71 patients with median age of 65 years (56 to 76) and SAPS II at admission of 49 (38 to 60). MRI was indicated on focal neurological sign in 13 (18%), seizure in 7 (10%), coma in 33 (46%), and delirium in 35 (49%). MRI was normal in 37 patients (52%) and showed cerebral infarcts in 21 (29%), leukoencephalopathy in 15 (21%), and mixed lesions in 6 (8%). EEG malignant pattern was more frequent in patients with ischemic stroke or leukoencephalopathy. Ischemic stroke was independently associated with disseminated intravascular coagulation (DIC), focal neurologic signs, increased mortality, and worse GOS at 6 months. CONCLUSIONS: Brain MRI in septic shock patients who developed acute brain dysfunction can reveal leukoencephalopathy and ischemic stroke, which is associated with DIC and increased mortality.

Ipsilateral ptosis as main feature of tuberothalamic artery infarction.

Tuberothalamic artery infarction (TTAI) results mainly in a myriad of neuropsychological symptoms such as memory impairment, euphoria, apathy, verbal perseverations, constructional apraxia and lack of spontaneity. Language disturbances, acalculia, buccofacial and limb apraxia occur prominently after left TTAI while visual spatial processing deficits and hemispatial neglect occur prominently after the right one. Some cases of TTAI causing Horner's syndrome in addition of these wide-ranging neurobehavioral symptoms have been reported. Here, we report a case of TTAI with an ipsilateral ptosis as main clinical manifestation. This finding suggests that a Horner's syndrome can be the main feature of TTAI when neuropsychological manifestations are inconspicuous.