Encephalitis

Researchers are evaluating the use of 64Cu-DOTATATE PETCTMRI imaging to improve diagnosis and monitoring of Lyme neuroborreliosis LNB, a tick-borne infection affecting the nervous system. This study aims to compare patients clinically suspected and cerebrospinal fluid CSF verified with LNB against those suspected without CSF verification. The goal is to see if this imaging technique can provide more precise diagnosis, prognostic information, and risk assessment for lingering symptoms after treatment. The study involves 50 patients divided into two groups 25 with possible or confirmed neuroborreliosis and 25 investigated but with normal CSF results. Participants will undergo 64Cu-DOTATATE PETCTMRI scans, which target activated macrophages involved in infection. This non-invasive imaging method is being assessed for its diagnostic value and ability to support follow-up six months after treatment, alongside blood biomarker testing including sCD163, NfL, and Tau. During the study, participants will have PETCTMRI scans to measure tracer uptake in the central nervous system and reference organs. Clinical symptoms, laboratory markers, and imaging results will be tracked to evaluate disease activity and prognosis. The primary outcomes focus on diagnostic performance over 2.5 years, with secondary measures also assessed. The study monitors patients without interventions beyond imaging and biomarker collection, lasting from initial evaluation through follow-up visits.

Researchers are studying the development of neural flexibility, measured by MRI, as an indicator of cognitive flexibility in Chinese toddlers aged 32 to 42 months. The study also evaluates executive functions such as inhibition, shifting attention, emotional control, working memory, and planning using the Global Executive Composite score from a standardized rating scale. This research aims to better understand brain development and cognitive abilities during early childhood. Participants are divided into two groups based on their daily milk consumption one group receives S-26 GOLD or ULTIMA GUM formula, while the other consumes cows milk. Parents continue feeding their children these milk products throughout the study, and information about milk consumption is collected starting up to two months before and during the study period. The brain is examined using MRI, a safe and non-invasive imaging technology. During the study, toddlers undergo MRI scans and assessments of brain structure and function at the start and again at 42 months of age. Researchers also evaluate cognitive flexibility, behavior, curiosity, sleep quality, home environment, feeding practices, and fecal microbiota composition over time. Parents provide information through interviews, and the childs development and school readiness are monitored. The study runs from baseline through 42 months of age, with additional home environment data collected at 8 months after baseline.

Researchers are evaluating the CIPHER System in patients undergoing brain tumor removal surgery for newly diagnosed supratentorial glioma. This First-in-Human clinical investigation aims to assess the safety and basic performance of a novel, highly flexible, electrode-dense cortical probe designed for neurophysiological mapping and stimulation during brain tumor resection. The study focuses on how well the device functions and its handling characteristics during short-term use in surgery. Participants will have the CIPHER Probe placed on the surface of the brain during standard tumor removal surgery. Two groups are studied one where only neural activity is recorded and another where both recording and electrical stimulation are performed using the probe. No stimulation is delivered in the recording-only group. The device is tested on the main tumor area and the surrounding tissue margin just before tumor removal. During the study, participants will be monitored through hospital visits during their recovery period, including follow-ups at two and six weeks after surgery. Researchers will collect data on any device or procedure-related adverse events, spontaneous neural activity, signal quality, and device deficiencies. The total study period includes enrollment through the six-week postoperative follow-up to evaluate safety and device performance.

Gliomas are aggressive tumors that originate from glial or stem cells, with patients typically surviving between 12 to 15 months. This research investigates whether a classic ketogenic diet CKD, which restricts carbohydrate intake and increases fat consumption to induce ketosis, can help extend survival in patients with high-grade gliomas and brain metastases. The study compares outcomes to historical controls to evaluate the diets potential therapeutic effect. Participants will follow the CKD for an initial period of 3 months, which is a high-fat, low-carbohydrate diet adjusted to each patients energy needs by dietitians. This diet aims to reduce blood glucose levels and increase ketone bodies to stimulate biochemical changes. Patients and their families will receive training on meal planning and ketoneglucose monitoring, and dietitians will provide ongoing support and follow-up visits. Throughout the study, participants will regularly monitor their urine and blood ketone levels daily and maintain records. Researchers will assess overall survival up to 36 months, tumor size changes, time to progression, quality of life, and functional impairment using established scales and surveys. Follow-up evaluations will occur at baseline and various intervals up to 24 months. The study includes safety assessments and continues monitoring until death or the study endpoint.

Researchers are studying anti-leucine-rich glioma-inactivated 1 LGI1 encephalitis, a type of autoimmune encephalitis that causes seizures, memory loss, behavior changes, sleep problems, and low sodium levels. This condition is the second most common autoimmune encephalitis after anti-NMDAR encephalitis. The study aims to prospectively investigate the clinical outcomes and factors associated with anti-LGI1 encephalitis, as previous prospective studies on this topic are limited. This observational study will enroll newly diagnosed patients during the acute stage before treatment. Participants will undergo various routine and advanced tests, including blood and cerebrospinal fluid analyses, brain MRI with multiple imaging techniques, EEG or continuous video EEG, PET scans, and neuropsychological assessments. These evaluations will be performed at the acute stage and throughout follow-up to analyze clinical outcomes and related factors. Participants will be monitored over time with assessments focused on seizure outcomes, clinical severity, recovery, and recurrence rates at one and two years. Secondary measures include memory tests and brain volume analysis. The study involves comprehensive testing and follow-up evaluations to better understand the disease progression and outcomes in patients with anti-LGI1 encephalitis.

Researchers are studying adults diagnosed with anti-N-methyl-D-aspartate receptor NMDAR encephalitis ANRE or anti-NMDAR autoantibody-associated psychiatric disease to evaluate the safety, tolerability, preliminary effectiveness, and how the body processes a drug called ART5803. This condition involves the immune system attacking parts of the brain, leading to loss of receptor function, and may be linked to psychiatric symptoms. The study is a Phase 2a, open-label trial led by Arialys Australia Pty Ltd. Participants will receive ART5803, a specialized antibody designed to bind the NMDAR receptor without interfering with its normal activity, while blocking harmful autoantibodies. The treatment is given by intravenous infusion initial participants receive 30 mgkg, and later participants may receive up to 60 mgkg. The schedule includes weekly infusions for 4 weeks, followed by infusions every two weeks for 8 weeks, totaling 8 doses. The study groups include adults with chronic, subacute, or acute ANRE, as well as those with anti-NMDAR autoantibody-associated psychiatric disease. During the 26-week study period, participants will undergo safety and tolerability assessments, patient-reported outcomes, neuropsychological tests, and evaluations of neurological and behavioral changes. Blood and cerebrospinal fluid samples will be collected to study how ART5803 is processed in the body. Participants will be monitored for changes in mobility, daily living activities, and psychiatric symptoms. The study aims to carefully track effects over time while ensuring participant safety.

Researchers are evaluating the safety, reactogenicity, and immune response of SK Japanese Encephalitis mRNA vaccines GBP560 in healthy adults aged 18 years and older. This 2-stage, Phase III randomized and observer-blinded study compares different doses and formulations of GBP560 with active comparators IXIARO and IMOJEV. The purpose is to understand how the vaccines perform in terms of safety and immune protection against Japanese Encephalitis Virus JEV. Participants receive two doses of the test vaccines or comparators at 4-week intervals. Stage 1 tests low, mid, and high doses 3, 15, and 50 micrograms of GBP560 variants A and B. Active comparators IXIARO and IMOJEV, as well as placebo saline for IMOJEV, are also given in Stage 1 and Stage 2. In Stage 2, participants receive two intramuscular injections aligned with the selected dose regimen from Stage 1. Throughout the study, participants are monitored for immediate reactions, local and systemic side effects, and any adverse events up to 24 months after vaccination. Immune responses are measured using live-virus neutralization tests at multiple time points up to two years after the second dose. Additional assessments include cell-mediated immune responses. The study includes regular visits for vaccinations, safety checks, and blood tests to evaluate the vaccines impact on immune protection and safety in healthy adults.

This research aims to evaluate the safety and effectiveness of acute transcranial direct current stimulation in patients with systemic autoimmune myopathies, a group of diseases that mainly affect skeletal muscles. These diseases vary widely, and this study addresses the lack of previous research on using this stimulation technique in such patients. The study is designed as a prospective, randomized, double-blind, placebo-controlled trial to rigorously test this approach. Participants will be assigned randomly to one of two groups one receiving transcranial direct current stimulation and the other receiving a placebo session. The stimulation involves placing two electrodes on the head, targeting the primary motor cortex, with a mild electric current delivered for 20 minutes while the patient is seated. This procedure will be repeated once daily for three days. The placebo group will not receive the actual stimulation. During the study, participants will be monitored closely for safety by checking for any treatment-related side effects shortly after stimulation and again after eight weeks. Researchers will also assess muscle disease activity, muscle strength, patient and physician evaluations, and blood muscle enzyme levels before, shortly after, and at 3 and 8 weeks post-stimulation. The study lasts for several weeks with multiple assessments to understand the treatments impact and safety over time.

Researchers are conducting a prospective, multicenter observational clinical registry involving adult patients aged 18 and older with suspected acute infectious meningitis, across about 30 public and private hospitals in Brazil. The study aims to gather real-world evidence on current clinical management, treatments, and both short- and long-term outcomes to support improvements in national care protocols. It focuses on meningitis caused by viral, bacterial, or fungal infections. Clinical and laboratory data will be collected during hospitalization and through follow-up visits after discharge. The data include timing and type of empirical antibiotic therapy, time from hospital admission to first antibiotic dose, corticosteroid therapy initiation, vaccination status according to the Brazilian National Immunization Program, neurological complications, and access to specialized rehabilitation services post-discharge. The study will assess outcomes such as mortality, hospital stay length, re-hospitalization rates, and sensorineural hearing loss. Participants will be monitored closely during hospitalization and after discharge, with data collection aimed at evaluating functional status through measures like the modified Rankin Score and Barthel Index. Researchers will track serious adverse events, neurological sequelae, and rehabilitation access over a period extending up to 180 days. This comprehensive follow-up will help inform public health and clinical care improvements in Brazil.

Researchers are evaluating the safety and effectiveness of a new device called the IRRAflow Active Fluid Exchange System compared to the standard External Ventricular Drain EVD in patients with brain bleeding and infections. This study focuses on conditions such as intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, and ventriculitis. The goal is to see if the IRRAflow device can better remove cerebrospinal fluid, blood, and harmful bacteria from specific brain spaces. Participants will be randomly assigned to receive either the IRRAflow device or the EVD device. Both devices are used to monitor and reduce intracranial pressure by draining excess fluid from the brain. The IRRAflow system includes an irrigation feature to help keep the drainage catheter clear by using programmed pulses of fluid, while the EVD device represents the current standard care method. After the procedure, participants will be followed for one month to compare outcomes between the two groups. During the study, participants will undergo various assessments including head CT scans to measure clearance of blood or bacterial mass, monitoring for catheter-related infections, tracking the length of stay in intensive care, and evaluating functional status at the start and 30 days after discharge. Researchers will also monitor rates of revision procedures, shunt dependency, and mortality during and after treatment. The study aims to provide detailed information about how these devices perform in managing intracranial bleeding and infections over a one-month period.