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Neurologic Manifestations clinical trials

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NCT ID: NCT05108207 Recruiting - Delirium Clinical Trials

A Software to Prevent Delirium (PREVEDEL) in Hospitalized Older Adults

PREVEDEL
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Background Delirium, is a clinical condition characterized by acute and fluctuating deterioration of the cognitive state, generally secondary to an acute pathology. It is a common condition in hospitalized older adults and it develops in 20-30% of patients hospitalized in a general ward and up to 80% of those hospitalized in critical care units. Delirium is associated with negative outcomes in older adults, such as longer hospitalizations, higher mortality, and short and medium-term institutionalization. Randomized clinical trials have shown that delirium is preventable through non-pharmacological prevention measures, decreasing its incidence by 30 to 50%. These interventions include promoting physical activity, facilitating the use of glasses and hearing aids, cognitive stimulation, and providing frequent reorientation of time and space, among others. These measures are currently seldom applied in hospitals in Chile and around the world for various reasons some of which include the heavy workload of clinical staff, the lack of trained personnel, and, in general, the absence of systematic implementation processes. The main objective is to evaluate whether cognitive stimulation guided by PREVEDEL software prevents delirium status(full/subsyncromal delirium) in hospitalized older adults. Method/Design: randomized controlled trial, parallel groups, multicenter. Participants: patients 65 years or older who have been hospitalized for less than 48 hours in the general ward or in the intermediate care unit of 4 hospitals in Santiago, Chile. Intervention: participants in the intervention group will use a tablet with cognitive stimulation software for delirium prevention for 5 continuous days versus the control group who will use the tablet without the software. Evaluations: The incidence of delirium and subsyndromal delirium, duration, density of delirium, cognitive and functional status at discharge, adherence to prevention measures, as well as demographic variables of interest will be evaluated.

NCT ID: NCT05086809 Completed - Hearing Loss Clinical Trials

Investigation of an Updated Bone-anchored Sound Processor

Start date: September 30, 2021
Phase: N/A
Study type: Interventional

The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor. The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.

NCT ID: NCT05075382 Withdrawn - Elbow Fracture Clinical Trials

Fracture and Neurological Injury

FIRE
Start date: July 1, 2022
Phase:
Study type: Observational

The goal of the project is to describe novel factors affecting outcome after elbow fracture surgery with an in-depth evaluation of the role played by neuro inflammation from concomitant peripheral nerve injury or head injury in elbow fracture outcomes. Among all upper limb fractures, elbow trauma is the most frequently associated with a severe impact on patient function and quality of life. One of the main reasons for poor outcomes is the complexity of the elbow joint, which involves three bones and two planes of motion, essential to position the hand in space. The flexion extension axis is crucial for eating and hygiene, while forearm pro-supination is mandatory for most professions, from office work to manual labour.

NCT ID: NCT04937452 Active, not recruiting - Dementia Clinical Trials

Dopaminergic Therapy for Frontotemporal Dementia Patients

Start date: June 3, 2021
Phase: Phase 2
Study type: Interventional

This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal administration at the dosage of 4 mg or 6 mg per day versus Placebo (PLC) in newly diagnosed behavioural Frontotemporal Dementia (bvFTD) patients. 75 patients with a diagnosis of probable bvFTD will be randomly allocated to the 3 treatment arms (RTG 4mg/day, RTG 6mg/day or PLC), with 25 patients per group. Clinical and neurophysiological measurements and brain metabolism via FDG-PET will be collected before and after drug administration.

NCT ID: NCT04912115 Suspended - Clinical trials for Nervous System Diseases

Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia

Start date: October 5, 2021
Phase: Phase 2
Study type: Interventional

A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson's Disease.

NCT ID: NCT04889313 Completed - COVID-19 Clinical Trials

Post COVID-19 Neurologic Symptoms : a Somatic Spectrum Disorder ? (SOMATiC)

SOMATiC
Start date: April 22, 2021
Phase:
Study type: Observational

A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. The pathophysiological mechanism is currently unknown, and several hypotheses have been put forward. Involvement of a Somatic Symptom Disorder (SSD) is plausible given the similarity of these symptoms with the Chronic Fatigue Syndrome identified as a SSD subtype. The objective of the SOMATiC study (SOMAtic symptom disorders Triggered by COVID-19) is to determine whether a positive diagnosis of SSD can be asserted in patients with persistent post-COVID-19 neurological symptoms.

NCT ID: NCT04855045 Recruiting - Eye Diseases Clinical Trials

An Open-label, Dose Escalation and Double-masked, Randomized, Controlled Trial Evaluating Safety and Tolerability of Sepofarsen in Children (<8 Years of Age) With LCA10 Caused by Mutations in the CEP290 Gene.

BRIGHTEN
Start date: March 23, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

PQ-110-005 (BRIGHTEN) is an open-label, dose escalation and double-masked, randomized, controlled study evaluating safety and tolerability of sepofarsen administered via intravitreal (IVT) injection in pediatric subjects (<8 years of age) with LCA10 due to the c.2991+1655A>G mutation over 24 months of treatment.

NCT ID: NCT04800809 Completed - Stroke Clinical Trials

The Afolabi Stroke Registry for Children and Young Adults With SCD in Northern Nigeria

Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

Sickle Cell Anemia (SCA) occurs in 300,000 newborns per year in the world, with 150,000 affected births in Nigeria, alone. With improvement in survival for children with SCA in both high- and low-resource countries, neurological morbidity is an emerging significant public health challenge, particularly in countries with a high rate of sickle cell disease (SCD). Both silent cerebral infarcts (SCI) and overt strokes result in significant neurological morbidity and premature death. Five NIH-funded randomized controlled trials (RCT) demonstrated that regular blood transfusion or hydroxyurea therapy are efficacious treatments for primary and secondary stroke prevention in children with SCA. Despite the observation that at least 99% of children with SCA in high-resource settings reach adulthood, and approximately 60% of adults will experience one or more strokes (~50% with SCI and ~10% with overt strokes) and the high disease-burden in Nigeria, the prevalence and incidence rates of new and recurrent stroke (overt and silent strokes)have not been collected systematically in children and young adults (16-25 years old) with SCA. In the last decade, there has been growing use of stroke registries in economically advanced nations, particularly for epidemiological purposes of trend analysis, clinical effectiveness, compliance to guidelines, assessment of implementation, adoption of novel techniques, and quality improvement process. For the first time in clinical centers in Nigeria, the Investigators will conduct an observational epidemiological study to document the prevalence and track the incidence of new and recurrent strokes in children and young adults with SCD. The Investigators will create a stroke registry referred to as the Afolabi Stroke Registry for Children and Young Adults with Sickle Cell Disease in Nigeria. The overall purpose of the stroke registry is to document the natural history of SCD in a low-resource setting and to improve the quality of the care of children and young adults with SCD living in Nigeria.

NCT ID: NCT04766645 Completed - Clinical trials for Neurologic Manifestations

ACE2 Gender Differences in Stroke With COVID-19

ACEGENDER
Start date: September 4, 2020
Phase:
Study type: Observational

The new coronavirus SARS-CoV-2, causes the COVID-19 infection, which showed a form of neurovirulence involving the Central and peripheral Nervous Systems [Baig et al, 2020]. In a mouse model for human ACE2 expression, the virus entered the brain mainly through the olfactory bulb pathway [Netland et al, 2008], with an encephalic invasion uniformly lethal even with low viral doses and without lung involvement. The death of the animal was reasonably related to neuronal dysfunction/death in cardiorespiratory bone marrow centers, while the absence of ACE2 prevented severe encephalopathy. Men has a highly frequency of severe and lethal COVID-19, and the observed gender difference could be related to the regulation of ACE2 receptor expression. The ACE2 gene is encoded by a region of the X chromosome that escapes inactivation, so that women have an increased expression of this protein. The process of inactivation of the X chromosome includes DNA methylation with a decrease in the expression of genes that are affected by methylation. In This way an epigenetic mechanism could modulate the expression of ACE2 in a gender-specific way determining its levels and consequently its protective role. Also in this regulatory context of ACE2 expression the role of microRNA (miRNA) could be very important. In fact, the untranslated 3' region (UTR) of ACE2 presents a binding sequence for miRNA miR-200c-3p that has been found at high levels of expression in cellular models infected with H5N1 influenza virus [Liu et al, 2017]. In addition, high plasma levels of miR-200c-3p were found in patients with severe pneumonia while ACE2 was reduced suggesting a regulatory role of this miRNA in ACE2 receptor expression [Liu et al, 2017]. Deficiency of 25 (OH)D is common among elderly and obese men (during winter and spring), highlighting the sex-specific difference observed in COVID-19 infection [La Vignera et al, 2020]. This vitamin, envolved in physical recovery [Siotto et al, 2019], and in the pathway of the renin angiotensin system, seems important to be assessed in ex-COVID-19 patients with stroke outcomes in admission and at the end of the rehabilitation process. The study will consist in: - Epigenetic study: evaluation of methylation of ACE2 promoter and miR-200c-3p levels. - Biochemical analysis: the evaluation of levels of angiotensin II, ACE2 and Vitamin D. - Correlation between rehabilitative outcome and biological markers

NCT ID: NCT04738539 Recruiting - Urologic Diseases Clinical Trials

Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

Start date: March 2, 2021
Phase:
Study type: Observational

The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.