Intracranial Hemorrhage

Aneurysmal subarachnoid hemorrhage (SAH) is a severe type of stroke that can cause early brain injury, vasospasm, and delayed cerebral ischemia. These complications are usually diagnosed using brain imaging techniques like CT scans, MRI, and arteriography, which require moving critically ill patients within the hospital, posing risks. This research aims to evaluate a new non-invasive bedside device using 3D enhanced ultrasonography to detect the main arteries in the brain's anterior circulation, potentially improving diagnosis without the need for transportation. Participants with aneurysmal SAH affecting the anterior circulation will undergo three bilateral transcranial enhanced ultrasonography scans using a device with microbubble contrast agent (Sonovue), performed at three key risk periods: days 0-2, 4-10, and 11-14. This pilot study will not alter standard care but will assess the quality of the imaging signal and compare findings with clinical outcomes. The study plans to include 15 patients at a single center. During the study, patients will receive the enhanced ultrasonography scans at bedside without moving to other hospital locations. Researchers will measure the presence and quality of the time-intensity curve from the contrast agent as the primary outcome. Secondary outcomes include comparing ultrasound data to clinical signs of brain injury and vasospasm, detecting principal arteries, and evaluating measurement consistency. The study will run until March 2025 and aims to assess feasibility and potential clinical benefits.

Researchers are evaluating the effect of involving caregivers in a rehabilitation approach called caregiver-assisted rehabilitation with strategy training (CAR-ST) to improve daily activity functions in adults who have had a stroke. The study aims to compare CAR-ST with strategy training alone and with an education program to see which approach leads to better improvements in activity performance and whether these improvements extend to other areas like participation and impairment. This is a single-blinded, three-arm randomized controlled trial conducted in multiple centers to assess the potential benefits of caregiver involvement in home-based post-stroke rehabilitation. Participants will be randomly assigned to one of three groups: CAR-ST, strategy training alone, or an education program. The CAR-ST and strategy training groups receive up to 10 therapist-guided sessions over a maximum of 6 weeks, with sessions once or twice weekly lasting about 60 minutes each. CAR-ST involves caregivers actively assisting and motivating participants during at-home practice, while the strategy training group does not include caregiver participation. The education group receives 10 matched sessions focused on stroke information delivered through face-to-face talks, video calls, or phone calls. During the study, participants will be assessed at four time points: before treatment, immediately after the intervention, and at 3- and 6-month follow-ups. Researchers will use various clinical tools to measure changes in activity performance, participation, quality of life, self-efficacy, motor function, cognition, and goal attainment. Qualitative interviews will also explore participant and caregiver experiences and satisfaction. The total involvement spans from baseline through six months after treatment, with continuous monitoring and data analysis to evaluate the interventions' impact.

Researchers are evaluating an investigational drug called OHB-607 to prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease in extremely premature infants. The study compares infants receiving OHB-607 to those receiving standard neonatal care to see if the drug can reduce the incidence of severe BPD or death by 36 weeks postmenstrual age. This is a Phase 2b, randomized, open-label study involving infants born between 23 weeks 0 days and 27 weeks 6 days gestational age. Participants in the trial will be randomly assigned to one of two groups. One group will receive a continuous intravenous infusion of OHB-607 from birth until 29 weeks and 6 days postmenstrual age. The other group will receive standard neonatal care without the investigational drug. This approach allows researchers to compare the effects of OHB-607 against routine care practices for preventing lung disease in these infants. During the study, infants will be closely monitored through 36 weeks postmenstrual age and up to 24 months corrected age. Researchers will assess lung health, including the incidence and severity of BPD, time to weaning off respiratory support, and other complications such as intraventricular hemorrhage and retinopathy of prematurity. Developmental outcomes will also be measured using standardized scales at 24 months corrected age. Safety assessments and long-term follow-up are included to understand the drug's effects over time.

Researchers are evaluating whether combining two non-invasive brain stimulation methods—muscle stimulation of the arm using functional electrical stimulation (FES) and neurostimulation through the tongue—can improve recovery after stroke. This study focuses on adults who have experienced a stroke and have upper extremity motor impairments, aiming to measure changes in motor function and brain plasticity using behavioral tests and functional MRI scans. Participants are divided into several groups including stroke patients with upper extremity impairments receiving EEG-guided brain-computer interface (BCI) training combined with muscle and tongue stimulation, stroke patients receiving traditional rehabilitation before starting BCI-FES-tongue therapy, stroke patients receiving standard FES therapy only, healthy controls, and people with stroke risk factors. The study involves training sessions with the EEG-BCI system, muscle and tongue stimulation, and the use of the recoveriX system, which provides real-time visual and tactile feedback paired with imagined hand movements. The intervention periods vary, with some groups receiving delayed therapy and others immediate BCI therapy. Participants will undergo multiple assessments including behavioral tests of upper extremity function, EEG recordings, and functional MRI scans at the start and after about four months of therapy. The researchers will monitor changes in arm function using the Action Research Arm Test and observe brain activity changes through EEG and fMRI. The study includes up to six BCI training sessions and regular evaluations over approximately 10 weeks, with some groups receiving additional follow-up MRI and behavioral testing. Safety screening excludes those with allergies to electrode materials or contraindications for MRI, and pregnant women are not eligible.

This research aims to evaluate a digital treatment combining an iPad-based cognitive training program called AKL-T01 with metacognitive strategy coaching to improve executive dysfunction, depression symptoms, and daily function in individuals who have experienced a stroke. The study focuses on those with post-stroke depression and executive dysfunction, conditions linked to ongoing mood and cognitive challenges. Researchers will assess whether this combined treatment enhances brain connectivity and overall functioning compared to a control group. Participants in the intervention group will use the AKL-T01 program for 25 minutes a day, five days a week, over six weeks. This program involves multitasking exercises in a video game-like environment using an iPad. Alongside this, they will receive weekly 45-minute coaching sessions with a clinician to reflect on their experiences and develop strategies for daily activities. The control group will engage in general cognitive games on the iPad for the same duration and frequency, also paired with similar coaching sessions. Throughout the study, participants will undergo assessments at the start and end of the six-week treatment period. These include tests measuring executive function, depression symptoms, daily functioning, and brain connectivity through MRI scans. Researchers will monitor adherence to the treatment and evaluate changes using standardized tools such as the Oral Symbol Digit Modalities Test, Montgomery Asberg Depression Rating Scale, and resting state functional MRI. The total study duration for each participant is six weeks.

Researchers are evaluating the effectiveness of a smart upper limb rehabilitation system combined with exoskeleton robot devices and an Internet of Things (IoT) application for home-based training in patients recovering from stroke and those with spinal cord injuries. The study aims to improve motor function, daily living activities, and quality of life by remotely monitoring rehabilitation progress and assisting patient movements. Participants are adults aged 20 to 79 years with specific cognitive and physical criteria depending on their condition. Participants are randomly assigned to one of two groups: the TIGER group, which uses a tenodesis-induced-grip exoskeleton robot system, or the TOT group, which receives task-oriented training. Each group follows a home-based training program for 4 weeks. For stroke patients, training is 30 minutes twice daily, 5 days a week; for spinal cord injury patients, training is 40 minutes once daily, 5 days a week. The TIGER system offers passive range of motion warm-up and functional training, while the TOT group practices sensorimotor techniques and functional tasks. Participants will undergo assessments before and after the intervention, including motor function tests like the Fugl-Meyer Assessment and Box and Block Test, range of motion measurements, and quality of life evaluations. Researchers will monitor progress in motor activity, independence, and satisfaction with assistive technology. The total study duration spans from baseline through 4 weeks of training, with outcome measures collected at baseline and after the intervention period.

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.

Researchers are studying brain activation patterns in stroke patients during mirror movement to understand upper limb function. This observational study focuses on patients who have had their first stroke, either cerebral infarction or cerebral hemorrhage, with specific muscle strength and muscle tone conditions. The study takes place in a hospital rehabilitation ward where patients receive detailed information and provide informed consent before participation. The study involves two types of hand movements: mirror image and healthy hand movement. In the mirror image intervention, patients place their affected hand in a mirror box and observe the reflection of the healthy hand moving, imagining the affected hand performing the same actions. In the healthy hand movement intervention, patients quickly open and grasp their healthy hand while focusing on the affected hand. The primary outcome is brain activation measured by functional near-infrared spectroscopy (fNIRS) after one week of hand function rehabilitation training. Participants will be closely monitored throughout the trial with full communication and support from the research team. The study involves observing brain activation and hand movement activity with attention to patients' questions and responses. The total participation period includes the initial week of rehabilitation training followed by assessments to measure the brain's response to the interventions.

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.