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Motor Neuron Disease clinical trials

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NCT ID: NCT06325865 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Perception of Unpleasant Sensations During Study Procedures in ALS Patients

PESALS
Start date: April 19, 2023
Phase:
Study type: Observational

Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients. Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state. This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures).

NCT ID: NCT06320444 Recruiting - Multiple Sclerosis Clinical Trials

Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease

Start date: June 15, 2023
Phase:
Study type: Observational

Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due to its unique alignment in spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. The overarching aim of this study is to reveal and quantify the extent of change in the sensorimotor integration and its potential contribution to network disruption in ALS.

NCT ID: NCT06318598 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis

DRIVEALS
Start date: April 11, 2023
Phase:
Study type: Observational

The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are: - Which set of biomarkers explain genotypic-phenotypic correlations in ALS? - Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups? Participants will undergo: - neurological evaluation - neurophysiological evaluation - neuropsychological evaluation - whole exome sequencing - biomarker measurement in CSF and plasma

NCT ID: NCT06318585 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases

ALS-PHENO
Start date: April 3, 2023
Phase:
Study type: Observational

Study Description: Characterization of Motor Neuron Disease Phenotypes The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are: - What are the specific clinical phenotypes associated with MND? - How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy? Participants will undergo: - Clinical evaluation using validated scales - Neurophysiological and neuroradiological instrumental assessment - Neuropsychological evaluation - Collection of biological materials for genetic screening and biomarker assessment, if necessary.

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: NCT06307301 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Study in ALS With Abatacept & IL-2

Start date: October 28, 2021
Phase: Phase 1
Study type: Interventional

In Amyotrophic Lateral Sclerosis (ALS), the reduction of regulatory T-lymphocyte (Treg) numbers and suppressive function correlates with rapid disease progression. The investigator completed a phase 1 study of infusions of expanded autologous Tregs in combination with subcutaneous IL-2 injections in ALS patients, which showed enhancement of Treg numbers and suppressive function in vivo. The enhanced Treg suppressive function correlated strongly with slowing and stabilization of disease progression. Drugs that enhance endogenous Treg numbers and suppressive function may also stabilize disease in ALS. This phase 1 study aims to determine whether the combination therapy of subcutaneous IL-2 and abatacept (Orencia®) is safe and well-tolerated in 6 patients with ALS, and whether the therapy enhances Treg numbers and suppressive function in vivo.

NCT ID: NCT06284161 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up

PEM-SLA
Start date: June 28, 2022
Phase: N/A
Study type: Interventional

Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems. The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis. The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis.

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.