"The Effect of Stellate Ganglion Block in Severe Brain Injury"
Traumatic Brain InjuryBrain Inflammation1 moreBlood flow through the brain is reduced after brain damage. Secondary brain ischemia caused by hypoxia and hypotension, further increase the susceptibility of the ischemically compromised brain to secondary impairment during this period. In order to determine whether and to what extent blockage of the stellate ganglion (BSG) affects the blood flow to the injured brain, the investigators will measure the variables of brain blood flow before and after BSG using computed tomography angiography (CTA), trans-cranial Doppler ultrasound (TCD), intracranial pressure (ICP) and perfusion computed tomography (PCT) of the brain. At the same time, the investigators would like to evaluate whether and to what extent BSG affects the aseptic inflammatory brain injury response and the biochemical indicators of brain damage in patients with moderate and severe brain injury.
IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2
PsychosisAutoimmune EncephalitisA randomised phase II double-blinded placebo-controlled trial designed to explore the utility of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes (NMDA-receptor or Voltage Gated Potassium Channel). Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes. Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.
A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab...
NMDAR Autoimmune EncephalitisLGI1 Autoimmune EncephalitisThe purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with anti-N-methyl-D-aspartic acid receptor (NMDAR) and anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis.
Regulating Emotions and Behaviors After Brain Injury
Acquired Brain InjuryStroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic)4 moreAfter acquired brain injury (ABI), persons can experience emotional and behavioral difficulties, that can be painful both for the person and his/her family. This clinical study aims at measuring the effectiveness of a third wave cognitive behavioral therapy called "dialectical behavior therapy" (DBT). DBT aims at teaching persons emotion regulation skills, interpersonal effectiveness skills, mindfulness and distress tolerance skills through group and individual sessions. The study's hypothesis is that DBT, in an adapted format for persons with ABI can lead to a better quality of life, emotional and behavioral regulation, and self-esteem decrease in problematic behaviors progress in life goals increase post traumatic growth and spirituality better family functioning and lesser burden for care givers experiencing more emotions and more free will 45 persons with an ABI sustained more than 18 month back, will follow a 3 phases, follow-up with care as usual for 5 months, followed by 5 months of DBT, followed by 5 months of care as usual + DBT monthly sessions. Self- and family-questionnaire will explore quality of life, emotional regulation, self-esteem, stress, anxiety, cognitive difficulties, family functioning and coping, post traumatic growth and spirituality and will be compared across the 3 phases. Results will be analyzed at a group level but also at an individual level (each patient separately) to test for decrease in unwanted behaviors and at a dyadic level (the person and his/her spouse) to test for the mutual effect of regulating emotions. Persons' memories will by analyzed at 3 time points by a linguistic analysis, and experience of free will after ABI will be analyzed by transcribed narratives of participants.
Tick-borne Encephalitis and Borrelial Antibodies in Serum
Tick Borne EncephalitisIn Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis. Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.
Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate...
Vaccine ReactionThe goal of this clinical trial is to evaluate the safety and reactogenicity of a VEE DNA Vaccine candidate delivered by either intramuscular or intradermal jet injection. The main question it aims to answer is: • Is the VEE DNA Vaccine candidate safe Participants will: Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection Provide blood and urine samples Complete ECGs Complete physical exams Complete diaries
SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral...
HIV Associated Neurocognitive DisorderHIV Dementia2 moreThe purpose of this study is to longitudinally characterize and evaluate changes in synaptic density in the brain using novel positron-emission tomography (PET) scans; magnetic resonance imaging (MRI), and clinical laboratory markers associated with HIV-related injury in the central nervous system. This study will test hypotheses relating to the presence and mechanisms of aberrant brain structure at the synaptic level in living humans with virologically controlled HIV on antiretroviral therapy. To evaluate associations between PET imaging radiotracers [11C]UCB-J, a ligand for presynaptic vesicle protein 2A (SV2A), a vesicle membrane protein expressed in synapses, and PET [11C]PBR28 a measure of microglia function in the brain, the Yale PET center has developed an advanced approach of combining multiple distinct ligands in coordinated same-day PET imaging. Additionally, the study will evaluate the associations of this novel synaptic density marker with well-established clinical measures of neurocognitive performance and laboratory measures of blood and cerebrospinal fluid (CSF).
An Exercise Intervention to Reduce Neuropathic Pain and Brain Inflammation After Spinal Cord Injury...
Spinal Cord InjuriesSpinal Cord Injury (SCI) leads to alterations in brain structure and function by spinal nerve damage, secondary inflammatory responses, and by the consequences of living with paralysis and neuropathic pain. Physical inactivity due to lower body paralysis rapidly leads to loss of muscle, and risk of heart disease. The leading cause of death after a spinal cord injury is cardiovascular disease, and just a year after injury, those with SCI have a peak exercise capacity half that of the unfit general population. The good news is that aerobic exercise reduces the risk of chronic metabolic and cardiorespiratory diseases, reduces inflammation and pain, and increases mood and quality of life. Exercise can also reduce brain inflammation, enhance endogenous analgesia, and increases the size of the hippocampus. The issue is that muscle paralysis in SCI restricts the ability to achieve the levels of exercise that is necessary for broad analgesic, anti-inflammatory and neuroprotective benefits. Arm exercise can have some effects on heart and lung capacity, but the small muscle mass is insufficient to produce more than modest aerobic work. With functional electrical stimulation (FES), leg muscles that are paralyzed can be made to contract, thereby allowing more of the body to be exercised. The full rowing stroke is produced by both the (stimulated) legs and arms, increasing the active muscle mass and resulting in an aerobic work-out that is intensive enough to improve heart, lung, and - maybe - brain function. In this clinical trial of sub-acute spinal cord injured subjects, the investigators will study how 12 weeks of FES-RT, in comparisons to 12 weeks of wait-list, changes pain, brain structure, endogenous opioid function and brain inflammation. The investigators will measure changes using positron emission tomography and magnetic resonance imaging. The investigators hypothesize a decrease in pain interference, an increase in hippocampal volume, increased endogenous opioid transmission in the periaqueductal gray, and decreased hippocampus neuroinflammation.
An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity
Infectious DiseaseYellow Fever2 moreWe hypothesize that a high CD4+ and CD8+ T cell count will reduce viremia upon challenge with a structurally heterologous virus, and correspondingly result in reduced magnitude of host response to challenge infection. Primary Objective: To compare, after challenge with a structurally heterologous vaccine, the differences in levels of viremia between healthy adults who received primary vaccination with either YF17D vaccine, chimeric JE-YF17D vaccine, or inactivated JE vaccine. 58 subjects will be randomised into 1 of 2 arms (Arm B1 and Arm B2) in a 1:1 ratio, in a double-blind fashion. Subjects in Arm B1 will receive JE-YF17D vaccine (Imojev, Sanofi Pasteur) on Day 0 followed by YF17D vaccine (Stamaril, Sanofi Pasteur) on Day 28. Subjects in Arm B2 will receive Stamaril on Day 0 followed by Imojev on Day 28. Arm B3 will be conducted as a separate single-arm open label design in 14 subjects. Subjects in Arm B3 will receive inactivated JE vaccine (Ixiaro, Valneva) on Day 0 followed by Stamaril on Day 28. The rationale for these three study arms is as follows: Arm B1 will show the impact low levels of viremia, and the resultant low levels of virus-specific CD4+ and CD8+ T cells, would have on YF17D infection. In contrast, YF17D vaccination in Arm B2 would produce high levels of viremia, and in turn high levels virus-specific T cells, thus likely ameliorating JE-YF17D infection. Arm B3 will serve as the control arm, as vaccination with inactivated JE vaccine would not produce any YF17D-specific T cell response. Notably, the first vaccination in Arms B1 and B2 would also provide the viremia response in the absence of virus-specific T cells, which would serve as a reference point to interpret the outcome of the second vaccination.
Neuropsychological Rehabilitation Over the Internet
StrokeAcute Ischemic5 moreHelsinki University Hospital (HUS) has decided on a strategy to provide digital health care services for several medical specialties - a project called the Health Village (HealthVillage.fi). Within Health Village a specific digital My Path program, iRENE Digital Pathway, has been developed for web-based neuropsychological rehabilitation. iRENE Digital Pathway is a structured program for adults with an acquired brain injury (ABI), which utilizes psychoeducative information and self-evaluation questionnaires for attentional, memory and executive disorders with a feedback, and provides training for internal and external memory and other cognitive strategies. The current study will explore if web-based neuropsychological rehabilitation is a feasible and effective method for carrying out rehabilitation for adults with ABI.