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Amyotrophic Lateral Sclerosis clinical trials

View clinical trials related to Amyotrophic Lateral Sclerosis.

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NCT ID: NCT06315673 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Digital Assessment of Speech and Fine Motor Control in ALS

Start date: April 1, 2024
Phase:
Study type: Observational

This is a single-session, case-control study that incorporates digital tools for assessing speech and motor function in motor neuron disease. Patients with motor neuron disease (including amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA)) and age-matched healthy controls will be enrolled. Subjects will complete a speech and handwriting assessment during the study visit on a tablet computer (BioSensics LLC, Newton, MA). We will explore whether these digital biomarkers are sensitive to functional disease severity as reported by the ALS Functional Rating Scale - Revised (ALFRS-R) [1]. We will also compare assessment data between the patient and control groups.

NCT ID: NCT06315608 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

MRG-001 in Patients With Amyotrophic Lateral Sclerosis

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

The proposed study is an Open-Label, Single-Dose Study to Assess the Safety, and Pharmacodynamics (PD) signals of MRG-001 in Patients with Amyotrophic Lateral Sclerosis (ALS). MRG-001 will be administered subcutaneously 3 times per week for 2 weeks. This cycle will be repeated for 3 months. In total, patients are expected to receive 18 injections over the span of 3 months.

NCT ID: NCT06280079 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Ultra-high-caloric, Fatty Diet in ALS

LIPCAL-ALS II
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS).

NCT ID: NCT06266403 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications

Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and age-matched speakers. The question is, What are the effects of communicative interaction on verbal communication in people with ALS? Participants will read words and sentences while they are in a solo setting and interactive setting.

NCT ID: NCT06249867 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS

Start date: March 2024
Phase: Phase 2
Study type: Interventional

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disorder characterized by selective death of upper and lower motor neurons, which leads to severe disability and fatal outcomes. One of the major hallmarks of ALS is the denervation of neuromuscular junctions (NMJs), which is one of the earliest events seen in ALS patients and mouse models of ALS. Under healthy conditions, glial cells called Perisynaptic Schwann Cells (PSCs) have a key role in regulating the stability and maintenance of NMJs, but they only participate in NMJ repair once denervation occurs. Denervation and the subsequent decline in synaptic activity triggers a loss of muscarinic acetylcholine receptors (mAChRs) in the PSC, and the resulting decrease in mAChR-mediated gene expression drives the "repair mode" of the PSC. In assessing the NMJ under conditions of ALS, a scarcity of process extensions in PSCs was observed for months prior to disease onset in the superoxide dismutase 1 (SOD1) mouse model of ALS, indicating inadequate glial repair. Collectively, these preclinical findings support the hypothesis that dampening glial mAChRs will restore the anticipated "repair" response of PSCs in the NMJ. Hence, the use of a selective M3 muscarinic receptor antagonist, Darifenacin, as a disease-modifying therapeutic in familial and sporadic ALS could improve NMJ function, resulting in a beneficial impact on the autonomy and quality of life of ALS patients. The purpose of the current Phase 2 trial is therefore to test the safety, tolerability, and pharmacology of Darifenacin in patients with ALS. Specifically, 30 eligible subjects between 18 and 85 years of age will take 7.5 mg of darifenacin or placebo daily (by mouth) for two weeks followed by an increased dose of 15 mg for the next 22 weeks. The trial will evaluate the effects of this medication on several outcome measures including patient safety, physical and neurological function, muscle strength, depression levels, and NMJ innervation of patients with ALS. Detailed clinical assessments will be conducted at regular intervals throughout the study in order to achieve these objectives.

NCT ID: NCT06249412 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis ALS7

The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in ALS Patients

PEPINEX
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder that impairs motor neurons, with a life expectancy of 2 to 7 years after diagnosis. ALS manifests as 'spinal' when it primarily affects limbs, or 'bulbar' when it impairs speech and swallowing. The disease progressively weakens all skeletal muscles, causing respiratory issues and increased risk of lung infections due to ineffective coughing. Mechanical cough assistance via In-exsufflation therapy/ mechanical in-exsufflator devie (INEX/MI-E) applies positive and negative airway pressures non-invasively to improve coughing. However, MI-E may fail in some ALS patients due to airway collapse, often related to brainstem muscle dysfunction.Research by Andersen et al. in 2017 highlighted that during MI-E, ALS patients often experience adverse laryngeal movements, which can obstruct airways and reduce the therapy's effectiveness. To combat this, they suggested individualized MI-E settings to minimize airway collapse. Modern MI-E devices, such as the EOVE-70, offer adjustable positive expiratory pressure (PEP) between cycles to potentially enhance airway stability and coughing efficiency. The current study focuses on the impact of PEP during therapy pauses on the peak expiratory flow rate in ALS patients, which could lead to improved therapeutic outcomes.

NCT ID: NCT06230562 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

DIAGALS: Relation Between Tar DNA Binding Protein(TDP)-43 et Nrf-2 in ALS: a Track to Improve Diagnosis and Prognosis of the Disease

DIAGALS
Start date: February 2024
Phase: N/A
Study type: Interventional

In response to oxidative stress, cells activate the Nrf-2 pathway, which induces translation of its target genes and corresponding proteins involved in the antioxidant response. This explains the interest in the Nrf-2 pathway in the pathophysiology of Amyotrophic lateral sclerosis (ALS), supported by the results of several studies and the modulatory effect of TDP-43 on the Nrf-2 pathway. Since both TDP-43 and Nrf-2 proteins are present in the peripheral blood mononuclear cells (PBMC) of ALS patients and may be correlated with disease progression, the investigators wish to explore their relationship and their application in the clinic as potential blood biomarkers for ALS.

NCT ID: NCT06181526 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Safety and Preliminary Efficacy of Aleeto in Amyotrophic Lateral Sclerosis

SPECIALS
Start date: December 15, 2023
Phase: Phase 1
Study type: Interventional

This study is a single-center, randomized, double-blind, placebo parallel-controlled, dose-escalation clinical study. The aim of this study was to evaluate the safety, tolerability, and preliminary effect of Aleeto in adult patients with ALS, and to provide an appropriate dose for the future clinical trial.

NCT ID: NCT06172621 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Spinal Cord Associative Plasticity for ALS

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Veterans are at higher risk than non-Veterans of falling ill with amyotrophic lateral sclerosis (ALS). As patients await a cure for ALS in the future, patients need more treatments now. The investigators have shown that pairing electrical stimulation over the cervical spinal cord synchronized with magnetic stimulation over the brain can temporarily strengthen weakened nerve circuits between the brain and hand muscles in people with ALS. The current proposal will take the next step of customizing this intervention for each individual, then applying it repetitively in an attempt to achieve direct clinical benefit on hand strength and function. The investigators will compare the effects of two-week programs of hand exercise versus paired brain-spinal stimulation versus the combination of exercise and stimulation. Not only will this project improve understanding of paired brain-spinal cord stimulation in ALS, but its eligibility criteria will also be more inclusive than most ALS studies, giving more Veterans an opportunity to participate in research aimed at treating this service-connected condition.

NCT ID: NCT06169696 Not yet recruiting - Clinical trials for Spinal Cord Injuries

EMPOWER Early Feasibility Study: Non-invasive BCI to Control a Wheelchair for People With Paralysis

Start date: November 2024
Phase: N/A
Study type: Interventional

Neuralis is an innovative assistive technology designed for individuals with severe neuromuscular conditions, enabling wheelchair control through EEG signals. This study aims to assess the safety, feasibility, and efficacy of Neuralis in restoring mobility and independence. The device is a discreet EEG headset which specializes in decoding signals from visual cortex, allowing users to initiate precise wheelchair movements through focused attention. This research seeks to demonstrate Neuralis' potential in revolutionizing assistive technology by offering a non-invasive, user-friendly solution for individuals facing motor impairments, ultimately enhancing their quality of life.