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NCT06856850
Diagnosis of ALS/FTD disease spectrum is challenging because it largely relies on clinical symptoms. Identifying novel biomarkers is essential for a paradigm shift towards a more precise biological-based diagnosis. To achieve this aim, having access to proper specimens and analytical methods is crucial. Our team of experts in neurology, biology, chemistry, physics, and AI will explore ALS/FTD from novel perspectives using transcriptomics, proteomics, genomics and other innovative approaches to analyzing easily accessible tissues. The seed amplification assay (SAA) will be also exploited to detect pathological TDP-43. This project aims to create disease fingerprints useful for patient stratification and monitoring of disease progression, and to evaluate the therapeutic efficacy in clinical trials, thus overcoming the limits of clinical interpretation. Discovering new biomarkers and cellular pathways will improve the diagnosis and treatment of these devastating diseases.
NCT05397106
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
NCT07440277
Background and study aims Idiopathic intracranial hypertension (IIH) is a neurological condition characterised by increased pressure inside the skull, called intracranial pressure (ICP). It is more common in women of reproductive age with obesity. Common symptoms of IIH include headaches, blurred vision and ringing in the ears. If left untreated, the disorder may cause blindness. The majority of patients with IIH are managed with weight loss and medications. Fewer than 10% of patients develop progressive visual loss and require urgent intervention to reduce ICP and preserve vision. This trial will compare the two most common interventions performed in the UK and evaluate their clinical and cost-effectiveness. The first is called cerebrospinal fluid (CSF) shunting and involves a procedure where a thin tube called a shunt is implanted in the body to drain brain fluid. The second is called dural venous sinus stenting (DVSS) and involves a procedure where a metallic mesh tube called a stent is implanted inside a brain blood vessel. Both procedures can preserve vision, but there is no strong evidence to support one over the other. Participants will have the same chance to be treated with CSF shunting or DVSS. The aim of the trial is to know which intervention is the most effective to save the vision and the most cost-effective. Who can participate? Adults with a diagnosis of IIH at risk of permanent sight loss What does the study involve? The trial will be conducted in NHS hospitals located in England, Wales and Scotland. Participants are randomly allocated to undergo cerebrospinal fluid (CSF) shunting or dural venous sinus stenting (DVSS). Afterwards the participants will be asked to attend 11 hospital appointments and one telephone appointment. This follow-up will take 2 years from start to finish. Participants will be closely monitored for any side effects and potential device failure, and for changes in vision, headaches and quality of life. The researchers will also collect health data from NHS Digital (the national custodian of NHS health and social care data). What are the possible benefits and risks of participating? There are no direct benefits from taking part in the trial but the information gained from this trial may help improve treatment for adults with IIH in the future. Participants may be seen more often and/or feel more supported as a consequence of their involvement in the trial. As with any intervention, there are risks and complications, but there are no additional disadvantages or risks involved in taking part in this trial. Both CSF shunting and stenting are treatments for IIH (shunting is widely used internationally, and in some hospitals, stenting is used as part of the standard of care). Participants require an intervention to prevent sight loss. None of these treatments is experimental but at present, there is not enough information to determine which treatment is most suitable and provides the higher level of health benefits to the individual. Where is the study run from? University of Birmingham (UK) When is the study starting and how long is it expected to run for? The first site opened in July 2023, and the last patient last visit is expected in May 2028 Who is funding the study? National Institute for Health Research (NIHR, grant number: NIHR131211) (UK) Who is the main contact? IIH Intervention Trial manager, IIHIntervention@trials.bham.ac.uk (UK)
NCT06928727
Craniosynostosis are cranial deformations due to the premature closure of one or more cranial sutures. These deformations affect approximately one in 2.500 births. In most cases, craniosynostoses are isolated with unknown (non syndrome). On the other hand, 20% of these deformations are associated with other concentration (syndrome). Craniosynostosis has morphological (associated dysmorphism) and functional (growth conflict between the skull and the brain) repercussions. Ophthalmological disorders are frequent: refractive disorders, oculomotor disorders, optic nerve damage, sensory damage. This retrospective study aims to describe the ocular clinical characteristics associated with craniosynostosis in patients followed at the Amiens University Hospital.
NCT07191873
This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing will be performed using analysis of covariance (ANCOVA), with the treatment indicator as the independent variable and the 12-month change in ICP as the dependent variable. Models will include baseline ICP as a covariate. This primary endpoint will use a significance level of 0.05 to declare significance.
NCT04459806
The new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting. Therefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.
NCT02896452
The investigators have documented a genetic predisposition for some astronauts to develop ophthalmologic issues (e.g., choroidal folds, cotton wool spots, optic disc edema). Women with polycystic ovary syndrome (PCOS) have several characteristics similar to those described in astronauts, including: higher homocysteine concentrations, increased incidence of intracranial hypertension, increased retinal nerve fiber layer thickness, increased incidence of white matter hyperintensities on MRI, increased androgen concentrations (or androgen responses to space flight), and indices of altered carbohydrate metabolism. Women with PCOS have not been evaluated in detail regarding the occurrence of other anomalies observed in astronauts including choroidal folds, optic disc edema and cotton wool spots as well as changes in cycloplegic refraction, and optic nerve sheath diameter. While researchers have evaluated one-carbon metabolism pathway polymorphisms re: PCOS, and initial studies show an association with certain one-carbon polymorphisms, none have looked at the complete set of SNPs proposed here. This study will evaluate women with PCOS and/or idiopathic intracranial hypertension (IIH) to assess one-carbon biochemistry and genetics and their possible correlation with ophthalmologic findings. The investigators aim to clarify the relationship of one carbon metabolism and ophthalmic findings in astronauts and patients with PCOS and/or IIH.
NCT06776614
Traumatic brain injury (TBI) patients often exhibit an increase in their intracranial volume due to blood collection or brain tissue edema. When the volume of any intracranial compartment exceeds a critical threshold, the compensatory mechanisms become exhausted, compromising intracranial compliance and blood supply, which leads to intracranial compartment syndrome (ICCS). The presence of this condition exacerbates brain damage through secondary injury. When less invasive measures to counteract ICCS prove to be insufficient, cranial decompression is recommended, with decompressive craniectomy (DC) being the preferred technique. Although its effectiveness has been demonstrated, DC is also associated with an incidence of complications. Expansive craniotomy (EC) has been proposed as an alternative that can increase the benefits of cranial decompression provided by DC while reducing the associated complications. This observational study will compare the functional outcomes and complications of patients managed by DC and EC.
NCT06254534
This clinical trial aims to compare the effects of lidocaine, dexmedetomidine, esmolol, and magnesium on optic nerve sheath diameter and hemodynamic response to laryngoscopy. The participants will be patients determined to need intubation and general anesthesia for any elective surgery. Each participant will receive either lidocaine, dexmedetomidine, esmolol, magnesium, or none before anesthesia induction, according to randomization. The investigator will measure the optic nerve sheath diameter by ultrasonography before and after intubation. Researchers will compare the difference between optic nerve sheath diameter, systolic blood pressure, and heart rate before and after laryngoscopy and search for the most stable group. The trial aims to determine a general anesthesia induction protocol for patients sensitive to intracranial pressure changes reflected as optic nerve sheath diameter for easy monitoring.
NCT06833424
This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.
NCT03212976
This study is designed to evaluate the accuracy of a non-invasive method phase-contrast magnetic resonance imaging (MR-ICP) for assessing intracranial pressure (Phase 1). To perform second phase contrast imaging to evaluate the patency and flow of ventricular catheters after MR-ICP imaging (Phase 2).
NCT06545981
The proposed study aims to evaluate optic nerve head blood flow and microcirculation in patients with idiopathic intracranial hypertension. For this purpose, optic nerve head blood flow will be examined in patients with IIH before and after therapy and additionally compared with healthy age- and sex-matched control subjects. In addition, other parameters will be measured, in particular retinal blood flow, retinal oxygen saturation and retinal neurovascular coupling.
NCT06571539
The goal of this clinical trial is to learn if high-accuracy augmented reality (AR) guidance for external ventricular drain (EVD) placement using a standalone head-worn navigation system can improve current shortcomings of freehand and image-guidance techniques. It will assess safety, feasibility and clinical performance. The main questions it aims to answer are: * Is the implementation of a standalone head-worn AR navigation system for EVD placement in critical care settings feasible and safe? * How does it compare to the conventional freehand technique in terms of EVD placement quality, complication rate and revision rate? Researchers will assess placement quality using the modified Kakarla scale, grading placement quality based on the position of the EVD tip on postoperative CT imaging. The amount of attempts, complications and revisions will be documented. The results of the AR-guided placements will be compared to a matched, non-concurrent freehand control group. Participants will undergo AR-guided EVD placement in a critical care setting (i.e. the emergency room or intensive care unit).
NCT06436820
This study aims to investigate the relationship between intracranial pressure (ICP) and aqueous outflow (the flow of the eye's internal fluid out of the eye), in patients with increased intracranial pressure (idiopathic intracranial hypertension (IIH)). Through observing changes in aqueous outflow facility in patients scheduled for lumbar Puncture (LP) as part of their routine care the objectives we aim to answer include: * Investigating the effect of lumbar puncture induced reduction in ICP on patients with known or suspected IIH, compared to control patients, who will be receiving LP for reasons not pertaining to high pressure. * Comparing pre lumbar puncture aqueous outflow facility between patients with idiopathic intracranial hypertension and control patients. Outside of the standard care provided for these patients as part of their scheduled lumbar puncture, they will have measurements of their eye taken before and after their lumbar puncture.
NCT06367868
Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP.
NCT06353412
Aim of the study : 1. to determine the response to each treatment plan. 2. to determine when to choose specific treatment method. 3. to determine complication of each type of treatment method
NCT04488874
Resection surgery of brain tumors by craniotomy requires efficient brain relaxation intraoperatively in order to avoid injuries caused by the brain retractors (such as ischemic-reperfusion and cerebral oedema). The gold standard for the brain relaxation during a surgery is Mannitol 20%. Molar sodium lactate is now used to induce brain relaxation in patients with traumatic brain injury and intracranial hypertension due to its osmotic effect. Furthermore, the injection of sodium lactate may lead to better neuronal metabolism during cerebral aggression, and may participate to the reduction of cerebral oedema and secondary injuries. LSD is a pilot randomised trial which tries to assess the interest of intravenous administration of molar Sodium Lactate on the quality of brain relaxation in surgical resection of supratentorial brain tumors by craniotomy. The primary outcome measure is the quality of brain relaxation, evaluated by neurosurgeon at the opening of the dura, by a validated brain relaxation scale.
NCT05946200
Laparoscopic cholecystectomy is one of the regularly performed laparoscopic surgical procedures. It resulted in shorter hospital stays, improved cosmetic outcomes, and reduced bleeding and pain. However, during laparoscopic surgeries, the pneumoperitoneum is known to raise intracranial pressure (ICP), reduction in cerebral blood flow (CBF), and as a consequence, cerebral hypoxia. There are various possible advantages of low-flow anesthesia. During laparoscopic procedures, low-flow anesthesia may be used as a means of preventing a rise in intracranial pressure and cerebral hypoxia. But low flow anesthesia effects on İCP are not known in Laparoscopic cholecystectomy. The primary aim of this study is to compare the effects of low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on ONSD in patients undergoing laparoscopic cholecystectomy. Seconder aims are regional cerebral oxygen saturation (rSO2), bispectral index (BIS), and evaluate the status of cognitive function in the postoperative 24th hours.
NCT03556085
The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH). The study will enroll 39 IIH subjects with moderate to severe visual field loss or severe headaches that have failed medical therapy. The primary safety endpoint is the rate of major adverse event at 12 months The primary probable benefit endpoint is a composite at 12 months of absence of significant sinus stenosis and clinically relevant improvement.
NCT05818371
Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.