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Nerve Degeneration clinical trials

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NCT ID: NCT06155942 Not yet recruiting - Parkinson Disease Clinical Trials

Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes

SODIPARK
Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is the most common degenerative Parkinson's syndrome and is linked, among other things, to the excessive accumulation of an abnormally aggregating protein, alpha-synuclein. Progressive Supranuclear Palsy (PSP) is another Parkinson's syndrome, linked, among other things, to the abnormal accumulation of the protein Tau, and expressed clinically by falls, early cognitive impairment and oculomotor disorders, not present in PD. The onset of these disorders is so gradual that differential diagnosis between the two diseases is only possible at a late stage, on average 3 to 5 years after the onset of symptoms. To date, there is a lack of validated imaging biomarkers for diagnosing and monitoring PD and PSP. There is therefore an urgent need for the development of robust biomarkers capable of detecting neurodegeneration at an early stage, in order to aid differential diagnosis as soon as symptoms appear, and to potentially enable these patients to be included in specific therapeutic trials (as these diseases are pathophysiologically different) with potential neuroprotective effects. The development of cutting-edge technologies such as 7T MRI, combined with optimized image processing methods, now enable non-invasive in vivo exploration and analysis of these small structures in terms of ion homeostasis (sodium), microstructure (volumetry, amount of iron and neuromelanin) and connectivity.

NCT ID: NCT06147596 Not yet recruiting - Concussion, Mild Clinical Trials

Heading in Football: Impact on Neural Blood Biomarkers

HEADLINE
Start date: June 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to evaluate the safety of heading in football. We will study the release of biomarkers in blood that reflect microscopic neural damage. The main questions this study aims to answer are: - Does participation in a football match lead to a change in biomarkers that reflect microscopic neural damage? - Is the dose of exposure during a football match related to the magnitude of change in biomarkers that reflect microscopic neural damage? Participants will participate in a regular football match and provide blood samples before and right after the football match. The football match will be recorded on video to count the number of headers of all participants.

NCT ID: NCT06088355 Not yet recruiting - Parkinson Disease Clinical Trials

Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease

HI-LITE
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Veterans with mid to later stage Parkinson's disease (PD) may not be able to work out as hard as they need to, to prevent brain cell loss. Maybe they could work out longer and more frequently to make up for this during their good times and good weeks and then rest during the bad weeks. The investigators will compare how effective working out a lot one week per month with a break of three weeks is to continuously exercising weekly with no breaks in people with mid stage PD. The investigators will look at how fast participants walk per minute, whether they become more physically active, the biochemicals in their blood, and at how stiff their blood vessels are before and after the exercise.

NCT ID: NCT05427656 Not yet recruiting - Clinical trials for Normal Healthy Adults

Imaging Biomarkers of Neuroplasticity and Neurodegeneration in the Living Human Brain

F18TRACK
Start date: August 1, 2022
Phase: Phase 1
Study type: Interventional

Following our recently completed whole body dosimetry study for [18F] TRACK in 6 healthy control subjects, the objective of this project is to evaluate brain uptake, regional distribution and in vivo pharmacokinetics for [18F] TRACK in 30 cognitively healthy controls using dynamic PET imaging. Specifically, we will evaluate [18F] TRACK in three cohorts of healthy control subjects of different ages and both sexes to further explore tracer kinetics in vivo and to determine the most appropriate and robust model to estimate tracer binding to TrkB/C. This will assess normal TrkB/C density in vivo and provide normative data for future use of these tracers in patients.

NCT ID: NCT05245344 Not yet recruiting - Healthy Clinical Trials

Effects of Ozanimod on Immune-mediated Mechanisms of Neurodegeneration in Multiple Sclerosis - a Preclinical Study

Start date: April 1, 2022
Phase:
Study type: Observational

This is a prospective non interventional study including patients with Relapsing-Remitting Multiple Sclerosis (RRMS) or with Neuromyelitis Optica Spectrum Disorders (NMOSD) and healthy subjects, who are enrolled within the routinely programmed clinical examinations at the IRCCS Neuromed (Pozzilli, Italy), IRCCS Polyclinic Hospital San Martino (Genoa, Italy) and Sant'Andrea Hospital - University of Rome La Sapienza (Rome, Italy). Specifically, the study investigates how ozanimod may contrast neurodegenerative mechanisms triggered by both arms of the adaptive immune response (T and B cells) and by their suboptimal regulation in MS. Overall, the project aims at assessing by in vitro experiments (there will be no patients on treatment with ozanimod and the drug will be only used in vitro): AIM1: ozanimod ability to modulate the synaptotoxic effect of T-cells derived from patients with MS relapse in a MS-chimeric ex-vivo model and to identify possible mediators (IRCCS Neuromed-Pozzilli, in collaboration with Synaptic Immunopathology Laboratory Dep. Systems Medicine, Tor Vergata University of Rome); AIM2: ozanimod ability to reduce the cytokine-mediated breakdown of the BBB and the migration of the here studied immune cells through ex vivo models of BBB (IRCCS Polyclinic Hospital San Martino); AIM3: ozanimod ability to affect the migration properties of Epstein Barr virus (EBV) infected B cells in MS (Sant'Andrea Hospital); AIM4: ozanimod ability to modulate the number and/or function of regulatory T cells (Treg), a lymphocyte population playing a key role in the control of pathogenic adaptive immune responses (Treg Cell Laboratory, Università degli Studi di Napoli "Federico II", Naples, Italy, receiving blood samples from Neuromed Hospital and Sant'Andrea Hospital; not recruiting unit). The work of the four labs is conceptually and operationally integrated: the labs at IRCCS Neuromed-Pozzilli/Tor Vergata University (Aim1) and at Polyclinic Hospital San Martino (Aim2) will investigate the effects of ozanimod on well-known mechanisms of damage in MS, inflammatory synaptopathy and BBB damage and immune cell migration. The lab at Sant'Andrea Hospital (Aim3), will verify whether B cells infected by different EBV genotypes are involved in BBB migration, and how ozanimod may interfere with this mechanism. The Treg Cell Laboratory (Aim4) will investigate whether ozanimod can also act "upstream" of these mechanisms by regulating the adaptive immune response.

NCT ID: NCT04808804 Not yet recruiting - Neurodegeneration Clinical Trials

Retinal Neurodegeneration In Type 2 Diabetes Mellitus Detected by Optical Coherence Tomography

Start date: June 2021
Phase:
Study type: Observational

Evaluation of retinal neurodegeneration in patients with type 2 diabetes mellitus (DM2) without diabetic retinopathy or with mild non proliferative diabetic retinopathy

NCT ID: NCT04605367 Not yet recruiting - Neuron Degeneration Clinical Trials

Mental Practice (MP) Combined With Transcranial Direct Current Stimulation (tDCS) on Motor Learning in the Elderly

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

Scientific background and rationale: Motor sequence learning (MSL) is composed of three phases: initial acquisition or rapid learning occurs during the first practice session, characterized by a rapid increase in motor performance; consolidation comes next, in the following hours, with a stabilization or even an increase in performance without additional practice; finally, slow learning allows long-term memorization of the skills acquired after several practice sessions. Motor sequence learning is an essential ability at any age but is altered with aging. Furthermore, the repetition of movements required for MSL may be tiring for the most vulnerable individuals. There is thus a need to develop the use of alternative and effective methods of MSL in the elderly. Mental practice (MP) based on motor imagery (MI) and anodal transcranial direct current stimulation (a-tDCS) are such innovative methods that have shown a positive impact on MSL in older adults. On the one hand, motor imagery training relates to mentally practicing movements without actual execution. This method has been shown to advantageously complement or even replace physical practice. Nevertheless, for fine and gross motor skills, the association MP/physical practice (PP) has been little studied in healthy elderly subjects. On the other hand, tDCS is a safe and noninvasive brain stimulation method used to modulate cortical excitability and enhance neuroplasticity. It has been shown that an anodal stimulation of the primary motor cortex (M1) immediately after the acquisition of a sequence of finger movements (manual task) enhanced consolidation in healthy elderly people. These effects have, however, never been tested for more ecological sequential tasks involving the whole body (body task). Aim: The main aim of this study is to investigate the effects of a-tDCS on the consolidation of complex manual and body tasks, after MP alone, PP alone, and MP + PP in older adults. A secondary aim is to test the effects of MP alone, PP alone and MP + PP in the acquisition of these complex manual and body tasks, in older adults. A third aim is to test the evolution of electroencephalographic (EEG) activity between rest and motor imagery of these tasks, and, for motor imagery, before and after training.

NCT ID: NCT04532944 Not yet recruiting - Multiple Sclerosis Clinical Trials

The Energetic Origin of Neurodegeneration in MS

ENERGYSEP
Start date: September 15, 2020
Phase: N/A
Study type: Interventional

In multiple sclerosis (MS), the sequence of events leading to irreversible neuro-axonal degeneration, which is a major determinant of clinical disability, is poorly understood. Recently, the key role of neuronal energy dysfunction in driving axonal degeneration has been highlighted. In the neuronal injury pathway triggered by inflammation and myelin disruption, multiple adaptive changes force the neuron to a temporary condition of "virtual hypoxia", characterized by a mismatch between energy demand and supply. If this condition of energy dysregulation is not reversed within an appropriate time-window, neurons enter an irreversible axonal degeneration. Two key questions on the relationship between early energy dysregulation and neurodegeneration remain unanswered: i) whether brain energy dysfunction measured at a given time point can predict the subsequent occurrence of neurodegeneration; ii) to what extent and for how long neurons can bear this "virtual hypoxia" before undergoing structural damage. Tracking the "energetic signature" of MS and defining its temporal distance from irreversible damage is essential for the development of neuroprotective therapies.The recent optimization of innovative magnetic resonance (MR)-based techniques such as sodium (23Na) MRI, phosphorus MR spectroscopy (31P-MRS), and diffusion-weighted 1H MRS (DW-MRS) has allowed the generation of promising in vivo data on cellular energy dysregulation in MS. The main objective of this project is to explore whether MR-derived metrics of energy dysregulation predict MR-derived parameters of cortical neurodegeneration developing over 2 years, as reflected by cortical atrophy. To address this key question, the Investigators will use a combination of 23Na MRI, 31P MRS, and DW-MRS associated with advanced MRI sequences to explore energy dysregulation in the sensorimotor region, and measurements of cortical atrophy in the same area after 24 months in 40 patients with either relapsing-remitting or progressive MS and 15 age- and gender-matched healthy controls. The Investigators will also test whether MR-derived metrics of energy dysregulation at study entry correlate, both cross-sectionally and longitudinally, with: i) global cortical atrophy; ii) functional cortical reorganization resulting from the condition of energy dysregulation, which precedes the occurrence of structural damage; iii) cortical demyelination and remyelination; iv) clinical, neuropsychological and biological measures.

NCT ID: NCT03825601 Not yet recruiting - Multiple Sclerosis Clinical Trials

PET With [18F]Flumazenil as an Index of Neurodegeneration in MS

FLUMA-SEP-T
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Beyond white matter pathology, grey matter damage is considered as a key player in disability onset and progression in Multiple Sclerosis (MS). The underlying substratum of grey matter damage is complex and pluriform, ranging from cortical demyelinating lesions, synapse and dendrite disappearance to neuronal cell death. Current Magnetic Resonance Imaging MRI techniques fail to fully assess and quantify grey matter pathology in this disease. The development of a quantitative marker of neurodegeneration for MS patients would allow: (i) to better understand the pathophysiological mechanisms underlying the distinct forms of MS; (ii) to stratify patients according to their prognosis; and (iii) to evaluate new therapies aimed at promoting neuroprotection. would allow to better understand the mechanisms underlying the distinct forms of MS, to stratify patients according to their prognosis, and to evaluate new therapies aimed at promoting neuroprotection.

NCT ID: NCT03572114 Not yet recruiting - Clinical trials for Mitochondrial Diseases

Imaging Neuromelanin and Iron in Dystonia/Parkinsonism

Start date: July 1, 2018
Phase:
Study type: Observational

To generate pilot data to investigate the potential to use in vivo iron- and neuromelanin-quantification as imaging tools for the diagnostic evaluation of movement disorders with predominant dystonia / parkinsonism. To this end we are planning to compare the MR imaging neuromelanin and iron-pattern and content in midbrain, striatum and further brain structures in clinically similar entities and respective, sex- and age-matched healthy controls.