Encephalitis

Researchers are evaluating the use of 64Cu-DOTATATE PET/CT/MRI 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 PET/CT/MRI 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 PET/CT/MRI 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 cow's 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 child's 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 diet's 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 patient's 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 ketone/glucose 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 evaluating the effects of different durations of dual-antiplatelet therapy (DAPT) followed by ticagrelor monotherapy in patients with symptomatic vertebral artery stenosis who have undergone Bridge implantation. The study compares the incidence of a combined outcome including non-fatal ischemic stroke, transient ischemic attack (TIA), and all-cause mortality over a 12-month follow-up period. This trial aims to determine the optimal length of DAPT to improve patient outcomes after the procedure. Participants are randomly assigned to one of two treatment groups: one group receives 3 months of dual-antiplatelet therapy followed by 9 months of ticagrelor alone, while the other group receives 6 months of dual-antiplatelet therapy followed by 6 months of ticagrelor monotherapy. The Bridge device (MicroPort NeuroTech, Shanghai, China) is implanted in all participants as part of the treatment for vertebral artery stenosis. Throughout the study, participants will be monitored regularly to assess the occurrence of stroke, TIA, mortality, bleeding events, and neurological outcomes at various time points, including 1 month and 12 months after treatment. Imaging follow-up will evaluate in-stent stenosis in a subgroup of patients. The primary outcome is measured at 12 months, and safety and efficacy are closely observed during this period. The total study duration for each participant is approximately one year.

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 mg/kg, and later participants may receive up to 60 mg/kg. 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 I/II 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 vaccine's impact on immune protection and safety in healthy adults.

Researchers are evaluating the effects of satralizumab on participants aged 12 years and older with either anti-N-methyl-D-aspartic acid receptor (NMDAR) or anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. This phase III clinical trial aims to assess the drug's effectiveness, safety, pharmacokinetics (PK), and pharmacodynamics (PD) in these autoimmune encephalitis conditions. The study includes both definite and probable cases of these diseases and compares satralizumab to a placebo to better understand its impact. Participants are divided into cohorts based on their specific diagnosis: adolescents and adults with NMDAR encephalitis and adults with LGI1 encephalitis. Satralizumab or placebo is administered subcutaneously according to body weight at scheduled visits starting at weeks 0, 2, 4, and then every four weeks. After the initial treatment phase, participants may choose to continue on the blinded study drug, start open-label satralizumab, or stop treatment while continuing follow-up assessments. Transition from the first to the second part of the study occurs either at primary analysis or week 52. Throughout the study, participants undergo regular assessments including monitoring of clinical improvements measured by the Modified Rankin Scale (mRS), seizure cessation, cognitive evaluations, and safety evaluations for adverse events. The study also tracks time to improvement without rescue therapy and changes in clinical assessment scales. Safety is monitored over several years, with participants followed up for adverse events for up to four years after week 52. Overall participation duration varies depending on individual treatment choices and study phases.

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 treatment's impact and safety over time.