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Brain Stem Infarctions clinical trials

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NCT ID: NCT04947124 Completed - Glaucoma Clinical Trials

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101

Start date: October 19, 2021
Phase: Phase 2
Study type: Interventional

Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).

NCT ID: NCT04735601 Recruiting - Glaucoma Clinical Trials

Ahmed Valve Implantation Coated With Poly Lactic -Co-glycolic Acid (PLGA) Saturated With Mitomycin-C in the Management of Adult Onset Glaucoma in Sturge Weber Syndrome

Start date: October 15, 2021
Phase: Phase 3
Study type: Interventional

Sturge weber's syndrome is an oculcutaneous syndrome, ocular manifestations may include heamangioma in the eye lids, choroidal heamangioma, or glaucoma, the glaucoma may present at infancy and may be due to resistance to aqueous outflow through trabecular meshwork(1), it may develop later and this is due to episcleral venous raised pressure.(2-3) Glaucoma associated with Sturge weber syndrome is difficult to be treated medically with high risk of complications when treated with bleb -based surgeries. Suprachoroidal hemorrhage or detachment is a challenging complication which must be encountered. The usage of Ahmed valve in the management of glaucoma associated with Sturge weber syndrome is a bleb based procedure carries the risks of over filtration or encapsulation and decreased filtration with failure to control glaucoma. The use of Ahmed valve in the management of pediatric glaucoma associated with Sturge weber syndrome has better results as recorded by Nassiri et al. Ahmed valve implantation can have some drawbacks such as pupillary irregularity, lens opacification, or encapsulation.(4-7) Glaucoma drainage devices such as Ahmed valve, Molteno or Braeveldt valve can be used when other methods of treatment fail, they provide alternative pathway to the aqueous to be collected in a plate positioned under the conjunctiva, (8-10) Encapsulation is a major problem occurs around the end plate due to fibrous reaction and so the drainage of the aqueous is decreased , Epatein (11) attributed that to fibro vascular proliferation in the episcleral tissue .the fibrous reaction is multifactorial , it may be due to the size of the end plate, the biomaterial, design or the shape of the plate. The use of drainage devices with advanced drug delivery system can improve the success of drainage device. A double-layered porous coating for Ahmed glaucoma valves based on biodegradable poly(lactic-co-glycolic acid) (PLGA) was described by Ponnusamy et al. [12] to produce continuous release of antifibrotic agents [mitomycin C (MMC) and/or 5-fluorouracil (5-FU)] to the subconjunctival space. This release continue for about one month with decreasing fibrosis, the nanofiltration membrane could entrap the proteins passing out from the anterior chamber leading to minimal increase in aqueous resistance.(12-13)

NCT ID: NCT04717427 Recruiting - Clinical trials for Sturge-Weber Syndrome

Longitudinal Studies to Identify Biomarkers for Sturge-Weber Syndrome

Start date: September 8, 2021
Phase:
Study type: Observational

Individuals with Sturge-Weber Syndrome (SWS) sometimes have brain involvement which can result in seizures, stroke-like episodes and neurologic deficits. The purpose of this study is to integrate longitudinal clinical data, radiological data, and blood biomarkers of Sturge-Weber syndrome patients. The research aims are: 1. To integrate longitudinal clinical data, radiological data, and blood biomarkers of Sturge-Weber syndrome patients. 2. Identify plasma and imaging biomarkers sensitive to exacerbation of clinical symptoms including seizures, headaches, or stroke-like episodes. 3. For enrolled patients who present with severe neurological symptoms screen blood samples for inflammatory changes. The target enrollment for this study is about 250 individuals diagnosed with Sturge-Weber Syndrome. The goal of this study is to understand more about Sturge-Weber Syndrome, the possible treatments for this disease, and identify targets for clinical trials. Those participating in the database will be asked to consent to blood draws.

NCT ID: NCT04517565 Recruiting - Clinical trials for Sturge-Weber Syndrome

Longitudinal Neuroimaging in Sturge-Weber Syndrome

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

In this project the accuracy of a novel, rapid magnetic resonance imaging (MRI) approach to detect brain abnormalities in patients with Sturge-Weber syndrome (SWS) will be tested; this new imaging approach, that can create multiple types of MR images in about 5 minutes, without contrast administration (and sedation even in young children), can be also readily applied in other pediatric brain disorders in the future. The investigators will also study how advanced MRI, including susceptibility-weighted and diffusion tensor imaging can detect detailed signs of brain vascular and neuronal reorganization that helps improve neurological and cognitive outcome of children and young adults with SWS, who could benefit from targeted interventions in the future to minimize neurocognitive deficits in affected patients. All enrolled subjects will undergo advanced brain MRI and neurocognitive evaluation to achieve these goals.

NCT ID: NCT04468919 Recruiting - Clinical trials for Spinal Cord Injuries

Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit

BCI-FIT
Start date: July 15, 2022
Phase: N/A
Study type: Interventional

This project adds to non-invasive BCIs for communication for adults with severe speech and physical impairments due to neurodegenerative diseases. Researchers will optimize & adapt BCI signal acquisition, signal processing, natural language processing, & clinical implementation. BCI-FIT relies on active inference and transfer learning to customize a completely adaptive intent estimation classifier to each user's multi-modality signals simultaneously. 3 specific aims are: 1. develop & evaluate methods for on-line & robust adaptation of multi-modal signal models to infer user intent; 2. develop & evaluate methods for efficient user intent inference through active querying, and 3. integrate partner & environment-supported language interaction & letter/word supplementation as input modality. The same 4 dependent variables are measured in each SA: typing speed, typing accuracy, information transfer rate (ITR), & user experience (UX) feedback. Four alternating-treatments single case experimental research designs will test hypotheses about optimizing user performance and technology performance for each aim.Tasks include copy-spelling with BCI-FIT to explore the effects of multi-modal access method configurations (SA1.3a), adaptive signal modeling (SA1.3b), & active querying (SA2.2), and story retell to examine the effects of language model enhancements. Five people with SSPI will be recruited for each study. Control participants will be recruited for experiments in SA2.2 and SA3.4. Study hypotheses are: (SA1.3a) A customized BCI-FIT configuration based on multi-modal input will improve typing accuracy on a copy-spelling task compared to the standard P300 matrix speller. (SA1.3b) Adaptive signal modeling will allow people with SSPI to typing accurately during a copy-spelling task with BCI-FIT without training a new model before each use. (SA2.2) Either of two methods of adaptive querying will improve BCI-FIT typing accuracy for users with mediocre AUC scores. (SA3.4) Language model enhancements, including a combination of partner and environmental input and word completion during typing, will improve typing performance with BCI-FIT, as measured by ITR during a story-retell task. Optimized recommendations for a multi-modal BCI for each end user will be established, based on an innovative combination of clinical expertise, user feedback, customized multi-modal sensor fusion, and reinforcement learning.

NCT ID: NCT04447846 Completed - Clinical trials for Sturge-Weber Syndrome

Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome

Start date: October 14, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to better understand the utility of cannabidiol (CBD/ Epidiolex) for improving the treatment of cognitive impairments in Sturge-Weber syndrome (SWS).

NCT ID: NCT04344626 Withdrawn - Stroke Clinical Trials

Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery

Start date: July 16, 2018
Phase: N/A
Study type: Interventional

Refractory epilepsy, meaning epilepsy that no longer responds to medication, is a common neurosurgical indication in children. In such cases, surgery is the treatment of choice. Complete resection of affected brain tissue is associated with highest probability of seizure freedom. However, epileptogenic brain tissue is visually identical to normal brain tissue, complicating complete resection. Modern investigative methods are of limited use. An important subjective assessment during surgery is that affected brain tissue feels stiffer, however there is presently no way to determine this without committing to resecting the affected area. It is hypothesized that intra-operative use of a tonometer (Diaton) will identify abnormal brain tissue stiffness in affected brain relative to normal brain. This will help identify stiffer brain regions without having to resect them. The objective is to determine if intra-operative use of a tonometer to measure brain tissue stiffness will offer additional precision in identifying epileptogenic lesions. In participants with refractory epilepsy, various locations on the cerebral cortex will be identified using standard pre-operative investigations like magnetic resonance imagin (MRI) and positron emission tomography (PET). These are areas of presumed normal and abnormal brain where the tonometer will be used during surgery to measure brain tissue stiffness. Brain tissue stiffness measurements will then be compared with results of routine pre-operative and intra-operative tests. Such comparisons will help determine if and to what extent intra-operative brain tissue stiffness measurements correlate with other tests and help identify epileptogenic brain tissue. 24 participants have already undergone intra-operative brain tonometry. Results in these participants are encouraging: abnormally high brain tissue stiffness measurements have consistently been identified and significantly associated with abnormal brain tissue. If the tonometer adequately identifies epileptogenic brain tissue through brain tissue stiffness measurements, it is possible that resection of identified tissue could lead to better post-operative outcomes, lowering seizure recurrences and neurological deficits.

NCT ID: NCT04308733 Recruiting - Dysphagia Clinical Trials

tDCS for Dysphagia Associated to Brainstem Stroke

Start date: March 30, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the effect of anodal transcranial direct current stimulation applied over the pharyngeal motor area in 60 dysphagic patients with acute isolated brainstem stroke. Thirty patients will undergo stimulation on the pharyngeal area contralateral to the side of brainstem lesion, and 30 patients will receive sham stimulation over the contralateral area, for 4 consecutive days. Patients will be re-evaluated after 4 consecutive days of stimulation. Primary outcome: The Penetration/Aspiration Scale after 4 consecutive days of stimulation. Secondary outcomes: changes in electromyographic parameters and pharyngeal cortical motor evoked potentials, changes in the Dysphagia Severity Rating Scale (DSRS), in the Functional Oral Intake Scale (FOIS), and in the "Dysphagia Limit Test", after 4 consecutive days of stimulation.

NCT ID: NCT04026581 Completed - Cerebral Palsy Clinical Trials

Real World Testing of a Brain-Computer Interface

Start date: June 5, 2019
Phase:
Study type: Observational

The goal of this project is to test a new AAC-BCI device comparing gel and dry electrode headgear used for communication while providing clinical care. Innovative resources will be employed to support the standard of care without considering limitations based on service billing codes. Clinical services will include AAC assessment, AAC-BCI device and treatment to individuals with minimal movement due to amyotrophic lateral sclerosis (ALS), brain stem strokes, severe cerebral palsy, traumatic brain injury (TBI) and their family support person. This is a descriptive study designed to measure and monitor the communication performance of individuals using the AAC-BCI, any other AAC strategies, their user satisfaction and perceptions of communication effectiveness, and the satisfaction of the family support persons.

NCT ID: NCT03567213 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Investigation on the Cortical Communication (CortiCom) System

CortiCom
Start date: December 14, 2021
Phase: N/A
Study type: Interventional

The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.