Brain Injury

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units ICUs. These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder PGD, post-traumatic stress disorder PTSD, and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation SC that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the interventions effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

This research aims to explore the clinical significance and causes of generalized vulnerability in older adult men with serious diseases including various cancers and fractures. It seeks to establish how common these causes are among patients with severe non-cancerous diseases, local and advanced cancers, and how these vulnerabilities affect the time to fully palliative care, overall survival, and quality of life. The study also evaluates how well common screening tools used in non-cancer patients detect vulnerability in older adults with cancer. Participants are men diagnosed with conditions such as prostate cancer, lung cancer, brain metastasis, pelvic fracture, chronic subdural hematoma, or those undergoing high-dose chemotherapy and stem cell transplantation. The study is observational and involves tests designed to determine vulnerability. Patients are required to have recent cross-sectional imaging and study procedures within defined timeframes relative to treatment or hospitalization. No experimental treatments are administered. During the study, participants will undergo assessments to detect causes of vulnerability around the time of study procedures. Researchers will monitor survival, timing of palliative care adoption, and patient-reported quality of life. The study will collect clinical data and imaging results. Participation involves observational data collection without additional treatment, with the study continuing until December 2030.

Researchers are evaluating the maximum safe and tolerated dose of Levetiracetam LEV for treating neonatal seizures. This Phase IIb, open-label dose-escalation study aims to determine if higher doses of LEV than currently used can improve seizure control in newborns. The study includes infants at risk or confirmed to have neonatal seizures of mild to moderate severity, with continuous video EEG monitoring used to assess seizure activity and control. Participants initially receive a 60 mgkg dose of LEV. If seizures persist after this dose, they are randomized to either receive higher doses of LEV 90 mgkg, 120 mgkg, or 180 mgkg in increments or treatment with Phenobarbital PHB at 20-40 mgkg. Maintenance treatment with PHB may continue for five days either intravenously or orally if tolerated. The study includes three phases, with Phase 3 expanding to neonates with more severe seizure burden if earlier phases show efficacy. Throughout the study, participants are monitored with continuous EEG reviewed by neurophysiologists to assess seizure control over 24 hours and changes in seizure burden during the two hours after treatment. Safety, pharmacokinetics, seizure freedom rates, adverse events, and long-term outcomes up to eight years are evaluated. The study also assesses new technology for neonatal seizure detection. Participation may last several years due to extended follow-up for long-term outcomes.

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 evaluating a low-cost augmented reality platform for balance training in patients with balance disorders caused by degenerative injuries or cerebrovascular diseases. The study aims to determine if the system is usable, acceptable, safe, and if it improves balance. The trial is a usability study conducted by the Hospital Universitari Vall dHebron Research Institute. The intervention has two phases the first phase lasts four weeks with supervised balance training sessions at the hospital, conducted for 60 minutes, three times a week. If patients meet inclusion criteria, the intervention continues for two additional weeks at home with a family member trained to assist as a training partner. The platform uses different exercise protocols accessed through RGSweb, including balance and sit-to-stand exercises with visual targets and movement tracking. Participants undergo three assessments before treatment Day 0, after the hospital phase Week 4, and after the home phase Week 6. Evaluations include usability scales, adherence measures, balance tests like the Berg Balance Scale, postural sway, sit-to-stand tests, balance confidence, and quality of life questionnaires. Safety is monitored throughout, and adherence is tracked during both hospital and home interventions.

Veterans face a heightened risk of suicide during the first year after leaving military service, especially those not connected to VA healthcare. This research aims to improve reintegration and reduce suicide risk for recently transitioned Veterans by evaluating STEP-Home-SP, a skills-based, video telehealth workshop. It is designed to provide suicide prevention education, support for accessing VA care, and tools to manage the transition effectively during this critical period. The study compares two groups one participating in the STEP-Home-SP workshop and the other receiving Enhanced Usual Care EUC, which includes standard care plus an educational packet on suicide risk and VA care connection. STEP-Home-SP involves weekly 1.5-hour group sessions over 12 weeks, focusing on emotional regulation, problem solving, and attention training, with up to six additional 30-minute individual sessions tailored to each Veterans needs. EUC involves existing transition support programs such as the Transition Assistance Program and VA Solid Start outreach. Participants will be assessed at multiple points over a year, including baseline, 12 weeks, and 24 weeks. Researchers will measure feasibility factors like recruitment and adherence, satisfaction with the program, and changes in reintegration status using the Military-to-Civilian Questionnaire. They will also monitor engagement with VA care and collect qualitative feedback. The study will help inform future larger trials and aims to address social isolation and suicide risk during Veterans transition to civilian life.

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.