Status Epilepticus

Researchers are evaluating RAP-219, an investigational drug, for adults with refractory focal epilepsy, a condition involving difficult-to-control focal seizures. This open-label, multi-center study aims to assess the long-term safety, tolerability, how the drug behaves in the body, and its antiseizure activity in adults who have not responded well to previous treatments. Participants will receive RAP-219 starting with one 0.125 mg capsule daily for 3 days, then one 0.25 mg tablet daily for 28 days, followed by one 0.75 mg tablet daily for the rest of the treatment period. The study is open-label, meaning all participants know they are receiving RAP-219, and the treatment period may last up to 112 weeks with ongoing monitoring. During the study, participants will be regularly assessed for treatment-related side effects and seizure frequency compared to their baseline before treatment. Researchers will monitor seizure-free days, longest seizure-free intervals, and other seizure-related measures using clinical assessments and RNS system data. Safety will be tracked through adverse event reporting up to 8 weeks after the last dose. The total participation duration can be up to about 2 years, with ongoing evaluations throughout.

Researchers are studying adolescents and young adults with autism spectrum disorder (ASD), a condition marked by difficulties in communication, social skills, and repetitive behaviors. The study aims to understand how a brain stimulation technique called transcranial direct current stimulation (tDCS) might reduce symptoms like anxiety and impulsivity. The research also seeks to use brain activity data and clinical information to predict who will respond well to this treatment. Participants will receive active tDCS for 10 sessions over two weeks, one session per day on working days. During each 20-minute session, they will perform exercises designed to improve processing speed and executive function while receiving brain stimulation. After treatment, participants will be classified as responders or non-responders based on improvements in social responsiveness scores. Throughout the study, participants will undergo various assessments including behavioral scales, cognitive tests, and neurophysiological measurements at the start and after the treatment period. Researchers will track changes in social communication, repetitive behaviors, and brain function. This will help determine the effects of tDCS and identify characteristics that predict treatment response, with the total study duration extending up to the final follow-up in 2026.

Researchers are developing a multicenter registry to collect and share data on pediatric patients who have undergone deep brain stimulation (DBS) for movement disorders such as dystonia, epilepsy, Tourette syndrome, and mood disorders. The study aims to improve understanding of DBS safety and effectiveness in children, as current data are limited and individual centers often have too few cases for strong research. This registry will support large-scale analyses and help refine DBS as a treatment option for hyperkinetic movement disorders in the pediatric population. The study involves gathering both retrospective and prospective clinical data from multiple pediatric centers. The registry will collect information on surgical techniques, patient outcomes, implant sites, and long-term effects of DBS. This collaborative data-sharing approach enables comprehensive evaluation of which patients benefit most from DBS and how it impacts their quality of life over time. Participants include children aged 0 to 18 years who have already received or are scheduled to receive DBS for neurological movement disorders. Data will be collected over five years to monitor safety, efficacy, and quality of life outcomes. The study does not involve treatment administration but focuses on gathering and analyzing clinical information. Parental or legal guardian consent is required for prospective participation.

Researchers are investigating epilepsy-dyskinesia syndromes, which are rare genetic diseases causing both movement disorders and epilepsy in children. This multinational retrospective survey, supported by the International Parkinson and Movement Disorder Society, aims to collect detailed clinical and molecular data to better understand these conditions. The study focuses on identifying patterns in disease features, progression, and genetic links to improve knowledge and support precision medicine. The study collects previously recorded data from multiple countries, harmonizing information on clinical features, disease progression, age of onset, genetic variants, and coexisting neurological conditions. By standardizing this data, the survey addresses challenges in rare disease research like small, dispersed patient groups and inconsistent protocols. The goal is to build a shared clinical database and analyze how movement and seizure disorders relate at both clinical and molecular levels. Participants are children aged 0 to 18 years with diagnosed movement disorders linked to specific genetic variants. The study reviews existing medical records and genetic information without new treatments or interventions. Researchers will assess the disease spectrum, how movement disorders affect quality of life, and the effectiveness of symptomatic treatments over one year. The study encourages international collaboration to advance understanding and improve care for these rare conditions.

Researchers are evaluating the safety, tolerability, and initial effectiveness of low-intensity focused ultrasound (LIFU) neuromodulation using the NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE). This pilot study involves adults with epilepsy that has not responded to standard medications, aiming to reduce abnormal brain activity and seizures. Participants will undergo six LIFU treatment sessions over three consecutive weeks. Each treatment uses specific ultrasound exposure settings delivered by the NaviFUS System. Before treatment, patients will be observed and asked to keep a seizure diary for 8 weeks. After completing treatments, there is a 12-week follow-up period to monitor outcomes. Patients may continue their anti-seizure medications throughout the study. Participants will keep a seizure diary throughout the study to track seizure frequency and severity. Researchers will also assess safety by monitoring adverse events for up to 23 weeks. Additional evaluations include EEG scans to observe changes in brain activity, and questionnaires that measure anxiety, depression, and the personal impact of epilepsy. The total study duration includes a 2-month baseline, 3 weeks of treatment, and 12 weeks of follow-up.

Researchers are evaluating the effectiveness and safety of a single dose of Staccato alprazolam compared with a placebo in quickly stopping prolonged seizure episodes in people aged 12 years and older. The study focuses on participants with stereotypical prolonged seizures, aiming to see if the treatment can stop seizures within 90 seconds and prevent recurrence up to 2 hours after administration. This is a Phase 3, randomized, double-blind, placebo-controlled trial sponsored by UCB Biopharma SRL. Participants will be randomly assigned to receive one inhaled dose of either Staccato alprazolam or a placebo during the treatment period. The study includes two arms: one with the active drug and one with placebo. Each participant will receive only a single dose by inhalation. The study is outpatient-based and conducted across multiple centers. During the study, participants will be monitored for treatment success, defined by seizure cessation within 90 seconds and no seizure recurrence up to 2 hours, with additional follow-up up to 6 hours. Researchers will assess seizure frequency, time to seizure stop, and possible respiratory adverse events. The safety follow-up visit will occur up to week 19. Participants will also have a study caregiver who can observe and recognize seizures. The total participation duration varies based on individual treatment and monitoring timelines.

Researchers are evaluating the use of Pulsed Low-Intensity Focused Ultrasound (PLIFU) to reduce or suppress seizure activity in adults experiencing non-convulsive or focal motor status epilepticus (SE) who have not responded to standard treatments. The study focuses on brain regions that generate or control seizures, aiming to assess the effects of this non-invasive brain stimulation in a hospital setting. Participants will receive up to two sessions of PLIFU treatment in the Intensive Care Unit. Each session lasts 10 minutes and uses a custom device that delivers ultrasound to specific brain areas without damaging tissue. Treatments will be given after anti-seizure medications have been administered, and the ultrasound is applied using safe, non-thermal settings. During the study, participants will be monitored continuously with surface EEG to measure epileptic brain activity before, during, and after PLIFU treatment. Researchers will observe changes in seizure activity and follow participants throughout their hospital stay. The main outcome is the change in epileptiform activity measured by EEG at baseline and 10 minutes after treatment. The study aims to gather preliminary data to support future research.

Researchers are evaluating the effectiveness of an AI-personalized mobile app called Medilepsy in improving medication adherence and transition readiness among underserved adolescents and young adults with epilepsy, ages 14 to 24, in Florida. This study compares the AI-enhanced version of the app with a standard version that does not include AI personalization. The research focuses on key outcomes including medical adherence, usability, and language experience. Participants are randomly assigned to one of two groups: the intervention group uses the AI-personalized Medilepsy app with an interactive Smart Chatbot that provides tailored prompts, adaptive education, and personalized support for epilepsy self-management. The comparison group receives a standard version of the Medilepsy app, which offers static prompts and general educational content without personalized feedback. The study lasts 3 to 6 months, during which participants use their assigned app version. During the study, participants will be monitored for medication adherence and transition readiness skills through app usage and assessments. Researchers will evaluate the usability of the app at the end of the 3 to 6 month period. The study collects data on how well the AI features support epilepsy management compared to the standard app version. Safety and participant engagement are also observed throughout the trial duration.

Researchers are evaluating the use of targeted transcranial direct current stimulation (tDCS) to treat refractory status epilepticus, a condition where seizures persist despite treatment with multiple antiepileptic drugs and anesthetics. The study aims to assess both the effectiveness and safety of this approach by comparing active tDCS stimulation to a sham (inactive) stimulation. This interventional trial is sponsored by Xuanwu Hospital, Beijing. Participants are randomly assigned to one of two groups. The active tDCS group receives cathodal current at 2 mA over the seizure onset zone for 20 minutes, twice a day, repeated over several days, but not exceeding 10 sessions. The sham group undergoes the same schedule and duration of treatment, but the device is not active during sessions. This design allows comparison between real and sham stimulation effects. During the study, participants will be monitored using EEG and assessed for seizure termination based on the Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus. Researchers will also track any treatment-related adverse events throughout the study, which lasts about one year from treatment start. This includes safety follow-up and outcome evaluations to better understand the potential benefits and risks of targeted tDCS for this severe seizure condition.

Stroke, severe brain injury, status epilepticus, and meningitis are serious neurological illnesses that often lead to seizures and infections, causing poor patient outcomes if not treated properly. This research focuses on a condition called augmented renal clearance (ARC), where kidney function is enhanced, affecting how medications are cleared from the body. The study aims to better understand ARC in patients with life-threatening neurological illnesses to improve medication dosing and treatment success. The study is a multicenter prospective observational design involving adult patients admitted to Neuroscience Intensive Care Units with severe neurological conditions like intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, status epilepticus, meningitis, and traumatic brain injury. Participants will have their kidney function measured daily through urine collection for up to 10 days or until ICU discharge. Blood samples will be collected from patients receiving certain anti-seizure and antibiotic medications to measure drug levels and suggest dose adjustments for those with ARC. During the study, researchers will collect urine and blood samples to detect ARC and its contributing factors. They will track kidney clearance and drug concentrations during hospital stays. The primary measures include creatinine clearance over 10 days or until ICU discharge and drug concentration after consistent dosing. This work aims to provide guidelines for identifying ARC and optimizing medication dosing to improve outcomes for patients with critical neurological illnesses.