Idiopathic Intracranial Hypertension

Researchers are studying cerebrospinal fluid leakage after supratentorial craniotomy, a surgery performed on the upper part of the brain to remove intracranial tumors. This leakage can occur when the protective covering of the brain, called the dura, does not close properly after surgery. Leakage can lead to wound healing problems, infections, longer hospital stays, and delays in additional treatments like radiotherapy or chemotherapy. Although less common in supratentorial surgeries than others, cerebrospinal fluid leakage remains a challenging complication that has not been well studied in this patient group. This observational study will follow patients undergoing supratentorial craniotomy to remove brain tumors. The study will track how often cerebrospinal fluid leaks occur, identify patient and surgical factors that increase risk, and observe how these leaks are treated. Data collection will include tumor characteristics, types of dural closure, materials used, and treatment approaches. The study will observe patients for six weeks after surgery, which aligns with the usual start of additional cancer treatments. Participants will be monitored for fluid leakage signs, infections at the surgical site, and any need for extra medical visits or hospital stays related to leakage. Researchers will evaluate the timing of leaks and details of surgical techniques used. The goal is to better understand leakage incidence, risk factors, and management to improve recovery after brain tumor surgery.

Researchers are evaluating the ability of the ShuntCheck test to detect flow or no flow in ventriculoperitoneal shunts among patients with asymptomatic normal pressure hydrocephalus. This observational study aims to determine the tests accuracy in identifying shunt function without symptoms, providing important information for routine care. Participants will undergo the ShuntCheck diagnostic test, which uses an FDA-cleared device that analyzes shunt flow through transcutaneous thermal convection. The study involves a single testing approach, with some assessments measuring the test performed twice to evaluate specificity and negative predictive value. During the study, participants will be monitored through the ShuntCheck test and routine clinical visits. Researchers will measure the specificity and negative predictive value of the test at 15 minutes and also assess these outcomes when the test is performed twice at 60 minutes. The study is sponsored by the University of South Florida and continues until November 2026.

Researchers are evaluating a daily nutraceutical supplement containing bioactive B vitamins to reduce optic disc edema in astronauts during long-duration space missions. This study focuses on optimizing the one-carbon metabolic pathway to improve enzyme function, enhance blood vessel health, strengthen eye tissue elasticity, and reduce retinal thickness changes. The investigation aims to better understand causes of optic disc edema and the effects of this nutritional countermeasure compared to astronauts who did not use supplements. Participants will take a vitamin B-complex supplement before, during, and after a 6 to 12 month spaceflight on the International Space Station. This supplement includes 5-methyltetrahydrofolate, riboflavin 5 phosphate, pyridoxal phosphate, and methylcobalamin. Blood samples are collected multiple times before, during, and after flight to assess vitamin levels, biochemistry, and genetic markers. Eye scans using optical coherence tomography and blood flow measurements will monitor ocular and vascular health. Throughout the study, participants will undergo various tests including blood draws, skin scans for advanced glycation end products, and fingertip temperature assessments to evaluate vascular function. Dietary intake, exercise logs, and medication use will be reviewed. The main outcome is measuring optic disc edema over six months, along with secondary measures of endothelial function, vitamin statuses, oxidative stress markers, and other biochemical indicators. The study lasts throughout the flight and follow-up periods to monitor ongoing effects.

Researchers are evaluating the safety and clinical performance of the BosSTENT, a new medical device designed specifically to treat pulse-synchronous tinnitus caused by venous sinus stenosis. The study aims to assess the long-term safety of the BosSTENT and its effect on reducing the severity of this type of tinnitus. This interventional trial is sponsored by Sonorous NV, Inc and targets adult participants aged 18 to 80 years with severe pulse-synchronous tinnitus that responds to jugular vein compression. Participants will undergo BosSTENT implantation in the transverse venous sinus. The study involves monitoring the incidence of major adverse events within three months after implantation and measuring improvement in tinnitus severity at 30 days using the Tinnitus Handicap Inventory THI. The trial does not include a comparator group or masking. The device is implanted to evaluate its therapeutic potential in this specific condition. During the study, participants must comply with all protocol requirements and attend clinical evaluations and follow-up visits. Researchers will track safety and tinnitus outcomes through clinical assessments and the THI questionnaire. The total study participation will extend at least three months after the procedure to monitor adverse events and treatment impact. Participants long-term health and tinnitus changes will be carefully observed under medical supervision throughout the trial period.

Researchers are investigating cerebral venous thrombosis CVT, a condition caused by blood clots in the veins of the brain, including cerebral venous sinus thrombosis, deep cerebral vein thrombosis, and cortical vein thrombosis. The study aims to understand the clinical features, natural progression, and current treatments of CVT in mainland China, where its epidemiology is not well known. This observational study is conducted across 31 provinces and municipalities in China, recruiting patients diagnosed with CVT using imaging methods like digital subtraction angiography, magnetic resonance venography, computed tomography venography, or high-resolution magnetic resonance imaging. After recruitment, blood and cerebrospinal fluid samples will be collected to explore the diseases pathological mechanisms and identify biomarkers. Patients will be followed for up to one year to assess their clinical outcomes and treatment effects. Participants will be evaluated at 1, 3, 6, and 12 months after enrollment through clinical assessments and follow-up visits. The study will measure outcomes such as death rate, functional independence, recurrence of different types of CVT, and complications including hemorrhagic events, sinus wall rupture, stroke, heart attack, pulmonary embolism, deep vein thrombosis, epilepsy, and allergic reactions. The total duration of participation is one year from baseline.

Researchers are evaluating a new non-invasive method to estimate intracranial pressure ICP and assess cerebral autoregulation CAR using the CoMind One EFS device. This observational study aims to develop safer alternatives to the current invasive ICP monitoring, which requires surgery to drill into the skull and carries risks like infection and pain. The study collects extensive data to improve the accuracy of this new technology for patients with conditions such as traumatic brain injury and stroke. Participants who are already receiving invasive ICP and arterial blood pressure ABP monitoring as part of their standard care will have concurrent measurements taken using the CoMind One EFS device. This device records a cerebral blood-flow index non-invasively, and these signals will be analyzed to create and test models estimating ICP without surgery. The study does not involve additional treatments but compares the new devices readings with existing invasive monitors during the observation period. During the study, participants will have simultaneous invasive and non-invasive ICP and ABP measurements recorded until either three weeks after removal of the CoMind device or discharge from the intensive care unit, whichever comes first. Researchers will analyze the data to evaluate the accuracy of the non-invasive device across different skin tones and its ability to detect changes in ICP states and trends. The goal is to gather detailed information to help develop a reliable, non-invasive ICP monitoring system.

Researchers are studying patients with traumatic brain injury, stroke, brain tumors, brain hemorrhages, and other neurotraumas to understand how blood vessel function relates to important brain pressures and blood flow. The study focuses on measuring blood vessel parameters like VasodilationConstriction Index, Vascular Resistance Index, and Volume Reactivity Index, and their connection to intracranial pressure and mean arterial pressure. This observational research aims to improve knowledge of cerebral blood flow and brain autoregulation in various neurological conditions. For the study, two FDA-approved noninvasive sensors will be placed on patients foreheads over the temporal area to measure brain oxygen levels and blood volume. These sensors collect data on regional tissue oxygen saturation and blood volume index. Blood pressure and intracranial pressure readings will be gathered from existing monitors. The sensors may be replaced every 6 hours if monitoring continues longer. This process allows continuous real-time tracking of blood vessel behavior and brain pressures. Participants will be monitored using the sensors and hospital equipment while continuous blood pressure and intracranial pressure monitoring are maintained. Investigators will analyze the collected data on cerebral oxygenation, blood volume changes, vascular resistance, and brain pressure to assess cerebral hemodynamics and autoregulation. The primary outcome measures these parameters over one hour. The study involves adults aged 18 to 100 with neurological injuries and requires consent and continuous monitoring during participation.

Researchers are evaluating the safety and effectiveness of two dural sealant devices, CraniSeal and DuraSeal, used during elective cranial surgeries. This post-approval study aims to determine whether CraniSeal is no worse than DuraSeal in preventing cerebrospinal fluid CSF leaks after surgery. The study also collects data on safety outcomes such as surgical site infections and adverse events related to the devices. Participants will be randomly assigned to receive either the CraniSeal or DuraSeal dural sealant as an addition to traditional sutured dural closure during their cranial surgery. Both devices are PEG-based dural sealants. The study is single-blinded and focuses on procedures involving either infratentorial or supratentorial cranial surgery with a clean surgical wound classification. During the study, participants will be monitored for 90 days after surgery to assess the absence of CSF leaks, the primary outcome measure. Researchers will also track additional safety outcomes and adverse events. Participants must comply with follow-up visits and evaluations as part of the study process. The total duration includes the postoperative period up to 90 days for safety and effectiveness assessments.

Researchers are evaluating the safety and effectiveness of two blood-thinning medications, dabigatran and apixaban, for adults who have experienced their first cerebral venous thrombosis CVT, a type of blood clot in the brains veins. This randomized controlled trial compares these two treatments by measuring rates of clot recurrence, recovery outcomes, vein reopening, headache impact, cognitive function, and bleeding complications over six months. Participants are randomly assigned to receive either dabigatran 150 mg twice daily or apixaban 5 mg twice daily for six months. The study includes two groups of 100 patients each. Throughout the study, patients undergo clinical evaluations, brain imaging scans, blood tests, heart and carotid artery monitoring when needed, and cognitive and headache assessments at baseline and at 30, 90, and 180 days. During the trial, participants will be monitored for venous recanalization by day 180 and for any bleeding complications related to the medication. Researchers will also assess functional recovery using the Modified Rankin Scale, cognitive ability with the MoCA test, headache severity with HIT-6, and any recurrent blood clots or vascular events such as pulmonary embolism or heart attack. Safety and treatment-related side effects will be tracked through follow-up questionnaires, ensuring comprehensive monitoring over the full six-month period.

Researchers are evaluating the safety and effectiveness of two blood-thinning drugs, dabigatran and rivaroxaban, for treating patients who have had their first cerebral venous thrombosis. This randomized controlled trial aims to compare how well a 150 mg twice daily dose of dabigatran works versus a 20 mg daily dose of rivaroxaban. The study will assess outcomes such as rates of recurrent venous thromboembolism, brain vein reopening, neurological function, and bleeding complications. The trial includes two groups of 100 patients each. One group receives dabigatran 150 mg twice daily, while the other takes rivaroxaban 20 mg once daily, both for six months. Participants will undergo clinical evaluations, brain scans, heart monitoring, blood tests, and neurological assessments at the start and at 30, 90, and 180 days. Imaging will be done at baseline and after six months, with urgent scans if clinical worsening occurs. Participants will be closely followed through interviews and questionnaires to measure brain function, headache impact, bleeding events, and other side effects. The main outcomes include the proportion of patients with partial or complete reopening of brain veins and the rate of bleeding complications by 180 days. Additional measures include neurological recovery, recurrent clots, and vascular events. Safety and treatment effects will be monitored throughout the study, which runs from August 2024 to November 2026.