Active clinical trials for "Amyotrophic Lateral Sclerosis"

The goal is to improve the fundamental knowledge about articulatory motor performance in people with Lou Gehrig's disease (also known as ALS) and Parkinson's disease (PD), in order to develop more sensitive assessments for progressive speech loss, which may lead to the improved timing of speech therapies.

Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron metabolism and programmed cell death ...). The platelets are pivotal in the healing system with large range of growth factors. A new therapeutic concept of conservative iron chelation with deferiprone for neuroprotection is under development. The action of deferiprone on the different mechanisms and notably the oxidative stress are to obtain from a collection of PBMC and platelets from patient having Parkinson's disease and Amyotrophic lateral sclerosis and healthy controls to study ex vivo. PBMC and platelets will be stored for future analyses.

This is a phase II feasibility, safety, tolerability and preliminary efficacy study of an e-Health application versus in-person nutritional counseling to maintain or increase weight in patients with neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), Parkinson's Disease (PD) and Huntington's disease (HD). Primary Objectives include the feasibility, safety, tolerability and efficacy of an e-Health application to maintain or increase body weight compared to in-person nutritional counseling. Secondary Objectives are to measure the number of calories required to maintain or increase body weight in neurodegenerative diseases at all stages of the disease. Tertiary Objectives are to test the effects of an e-Health application compared to in-person nutritional counseling on disease progression using the ALSFRS-R, UHDRS or UDysRS, on survival, and on quality of life using the PROMIS SF v1.1 scale.

Motor neurone disease (MND) is a rare but debilitating neurological condition that causes paralysis of the body's muscles leading to severe disability and eventually death. Patients often struggle to travel the long distances to specialist clinics to receive the care they require whilst this expert care is often unavailable in the community. Telehealth has the potential to enable a specialist team to monitor the health and wellbeing of patients and their carers whilst they are at home. This could improve the patient's health, improve the quality of life of both patients and their carers, and lead to more effective use of health resources. This is a randomised controlled pilot study that will involve 40 patients who are cared for by the Sheffield Motor Neurone Disease care centre and their main informal carer (a total of 80 participants). Half of the participants will use the telehealth system for a minimum of six months and maximum of eighteen months and information will be collected from patients, carers and their care team. This will include collecting clinical outcome measures, health resource use and the opinions and experience of using the system. All participants will continue to receive their usual care. This is a pilot study. It aims to determine the feasibility and acceptability of the telehealth system to patients, carers and their health care providers. It also aims to determine how a larger trial could successfully evaluate the clinical and cost-effectiveness of the system.

Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new meaningful measure(s) which might prove to be more effective than existing measures for monitoring clinical function and disease course in ALS. The objective of this study is to test novel measures of movement/physical activity, heart rate and speech and explore how they measure disease progression by evaluating their relationship to gold standard measures of function. This study will be conducted in two phases. A variable length Pilot Phase to test biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately 5 subjects will have at least 1 clinic visit to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (i.e., home monitoring). Subjects in the Pilot Phase will continue in the study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be enrolled. Subjects will attend 5 clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, every month subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period. All third party trademark rights are the rights of their respective owners.

Motor neurone disease is a progressive incurable disease causing weakness and paralysis of muscles. Respiratory failure is the most common cause of death in motor neurone disease. Patients with respiratory failure use a machine that supports breathing using a mask and ventilator (non-invasive ventilation: NIV) and using it for more than five hours per night has been shown to prolong life and improve symptoms such as poor sleep and breathlessness. NIV is however, challenging to use and some patients are unable to adhere to the required regime meaning they fail to gain benefit. Timely support is important to help individuals overcome early hurdles and barriers to using becoming regular NIV users. The Philips EncoreAnywhere is a system that allows continuous monitoring of the use and effectiveness of ventilation and allows instant adjustment of ventilator settings. The aim of this project is to explore if "real time" feedback and support, as well as remote changes to NIV settings using the EncoreAnywhere system could increase the number of individuals successfully using NIV. This project also aims to explore the impact of using EncoreAnywhere on the process of initiation of NIV, on both patients and staff. Patients starting NIV at the Sheffield MND care centre will be provided with the standard ventilator plus a Philips modem for the first three months of use. In half the patients clinicians will be able to use the EncoreAnywhere system to review patients' use of NIV, make adjustments and give feedback. In the other half, the data will be collected but not available to the clinical team. Clinical data will be collected as part of usual care: adherence, clinical encounters and resource use and patients will be asked to complete questionnaires at baseline, one month and three months. This will allow the care team to predict the potential impact on the service and on clinical care. This is a small pilot, feasibility study, and if the study is deemed feasible, a further larger randomized controlled trial is planned. The study will last for a maximum of 12 months, recruiting up to 40 patients.

Eighteen ALS patients will be trained to control a new communication device (Eye On Line: EOL) that permit over smooth eye movements to generate digits, letters, words or drawing at will. The intervention consists in a training program during six visits over 3 weeks on site allowing a gradual acquisition of the eye-writing. The primary objective of the study is to assess the feasibility of the use of EOL device in ALS patients. The EOL device potentially offers a creative and personal means of linguistic and emotional expression in subject with motor disability.

The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.

Primary aim of the trial to verify safety and tolerability of expanded human fetal neural stem cells to verify safety and tolerability of a microsurgery human fetal neural stem cells transplantation model to recognize each change in patient's quality of life Secondary aim of the trial assessment of the impact of human neural stem cells transplantation on the disability of ALS in a clinically significant and measurable way Assessment of the impact of human neural stem cells transplantation on mortality (all causes)

The overall goal of this protocol is to evaluate microglial activation in the brain using [18F]PBR06 in patients with amyotrophic lateral sclerosis (ALS).