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Amyotrophic Lateral Sclerosis clinical trials

View clinical trials related to Amyotrophic Lateral Sclerosis.

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NCT ID: NCT05784727 Not yet recruiting - Clinical trials for Motor Neuron Disease

Technical Evaluation of Earswitch Phase A

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to test the Earswitch device in both participants with and without assistive technology (AT) needs. The main aim is to determine how robust the Earswitch is in detecting voluntary eardrum movements (known as ear rumbling) and see how well the Earswitch fits with other assistive technology. To do this, participants will be asked to wear the Earswitch device and voluntarily contract their TT to complete a series of tasks shown on screen and/or explained audibly. Participants will be asked to complete questionnaires to understand their opinions about the effectiveness, usability, and comfort of both their current device (if applicable) and the Earswitch. This feedback will be invaluable in developing the Earswitch.

NCT ID: NCT05768646 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Counterfactual Thinking in Amyotrophic Lateral Sclerosis

Start date: March 31, 2021
Study type: Observational

The properness of our past choices and action is usually judged according to what could have been if we had behaved differently. This ability to simulate alternatives to past factual events and actions is called counterfactual thinking (CFT) and is closely related to the decision-making process and future behaviors. In fact, the generation of CFT fulfills an important preparatory function, since it offers behavioral instructions that can guide the individual in facing similar decision-making problems in the future. Consequently, a damage or a reduction in the CFT are likely to impact on the individual's decision-making (DM) ability, especially regarding crucial decisions such as those in the medical field. In recent years, growing evidence has highlighted alterations in CFT in several neurological, neurodegenerative and psychiatric conditions, such as Huntington's disease, Parkinson's disease, prefrontal cortex damage, schizophrenia, obsessive-compulsive disorder and major depressive disorder, underlining how CFT deficits are specifically associated with frontal-executive dysfunction. These alterations, as mentioned, can lead to non-optimal DM processes and behaviors. Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease characterized by the loss of motor neurons in the spinal cord, brain stem and motor cortex. Literature data have highlighted the presence of cognitive and behavioral alterations as integral parts of the disease, as a part of a continuum, with a partial overlap, between ALS and frontotemporal dementia (FTD). The progressive and fatal course of the disease and the presence of cognitive/behavioral alterations, together with the impairment in communication skills, have significant implications on patient's competence in the advance care planning, especially regarding informed consent to advance treatment and end-of-life decision. In particular, patients' perspectives about therapeutic choices and end-of-life interventions are likely to be influenced by cognitive-behavioral aspects, where the integrity of frontal-executive functions plays a crucial role in patients' DM ability. The investigators hypothesize that ALS patients will show a certain deficit in CFT, both in the ability to generate counterfactual thoughts related to a negative real-life and in the ability to use CFT to make causal inferences in fictional social scenarios. Moreover, a relationship between CFT and DM abilities is expected to be found. These expected impairments are likely to be associated with the cognitive and behavioral alterations that typically occur in ALS. Primary aim The primary purpose of the study is to investigate the integrity of CFT ability in patients with ALS. Specifically, this study aims to: (1) evaluate the functioning of the CFT in a group of patients affected by ALS; (2) investigate how the functioning of the CFT is associated with the ALS typical cognitive-behavioral alterations; (3) evaluate the possible association between CFT and DM abilities; (4) investigate how clinical, psychological, cognitive and behavioral variables affect CFT integrity. Secondary aim CFT ability will be investigated along the course of the disease, with patients being recruited in a longitudinal study. When possible, according to clinical conditions, patients will be assessed at 0-6-12-24 months, in order to better characterize CFT and DM functioning over time, as well as patients' cognitive-behavioral profile. . We expect to highlight a deficit or a reduction in patients' CFT ability and such alteration is likely to be associated with DM skills, as well as with the specific cognitive and behavioral profile of ALS patients.

NCT ID: NCT05764434 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

ALS Spinal Cord Gray and White Matter Study

Start date: May 1, 2018
Study type: Observational

This study aims to measure in vivo the spinal cord gray and white matter in patients with Amyotrophic Lateral Sclerosis and healthy persons that match the patients' age and sex using rAMIRA imaging, a novel Magnetic Resonance Imaging (MRI) method. Patients and healthy control persons prospectively undergo MRI examinations, clinical examinations including assessments of disability, and tests of muscle force using hand held dynamometry. Serum markers of neuro-axonal injury are also assessed. Examinations for patients and healthy control persons are scheduled every six months over a time span of two years.

NCT ID: NCT05753852 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Open Label Extension of TUDCA-ALS Study

Start date: October 25, 2021
Phase: Phase 3
Study type: Interventional

This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.

NCT ID: NCT05747937 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

The goal of this interventional non-pharmacological study is to evaluate, using a multimodal approach, the progression of autonomic and sensory involvement in in amyotrophic lateral sclerosis (ALS) patients enrolled within 18 months from motor onset and its relationship with the progression of overall clinical disability. The main questions it aims to answer are: - Is autonomic dysfunction at diagnosis associated with disease progression and survival in patients with Amyotrophic Lateral Sclerosis ? - Can we identify in the skin biomarkers to be used as reliable measures of disease progression and to apply in future clinical trials for patient stratification and to assess response to drug treatment ? Participants at time 0 will receive a full clinical and instrumental examination and a blood sample testing to check inclusion and exclusion criteria, genetic screening for the most common genes associated with ALS (SOD1, FUS, TARDBP and c9orf72), questionnaires about clinical characteristics, quality of life, pain and a multidomain battery of neuropsychological tests, multimodal assessment of the autonomic nervous system including skin biopsy for morphological study. At follow-up we'll perform clinical scales and skin biopsy. Researchers will compare results from ALS patients with data obtained from a population of age and sex matched healthy subjects.

NCT ID: NCT05744310 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families

Start date: March 6, 2023
Phase: N/A
Study type: Interventional

Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is two to three years. The patient physical and psychological sufferings in ALS are immense, and apart from Riluzole, there is no effective treatment. Care of advanced ALS have an estimated cost of 4-8 million NOK per year. Perhaps the most challenging topic of ALS care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. In these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (TIV) or non-invasive (NIV) modality. The present study is a longitudinal questionnaire study in Norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in ALS patients, partners and children before and after the introduction of life sustaining ventilation support. The investigators aim to increase the knowledge on how life-sustaining ventilation support with NIV or TIV affects the quality of life in ALS patients, life partners and children. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. The investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.

NCT ID: NCT05742828 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Virtual Seating Coach on Power Wheelchairs of Persons With Amyotrophic Lateral Sclerosis (ALS)

Start date: September 20, 2017
Phase: N/A
Study type: Interventional

A literature review was completed related to the topic of use of the Virtual Seating Coach (VSC) device with clients with Amyotrophic Lateral Sclerosis (ALS) with no results. The VSC components are FDA approved and Health Insurance Portability and Accountability Act (HIPPA) compliant, which have been used for many years by clinicians to achieve therapy goals of repositioning and best practice of utilizing power wheelchair seat functioning on a frequent basis. The VSC is typically not covered by insurance, but with clinical documentation, it has the potential for reimbursement. There is conflicting and vague information in the literature with regards to the prevalence/types of wounds and prevalence of pain in this population.

NCT ID: NCT05740813 Not yet recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262

Start date: March 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen F will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, in participants with ALS.

NCT ID: NCT05725759 Enrolling by invitation - Clinical trials for Amyotrophic Lateral Sclerosis

Rehabilitation in SOD1 ALS Treated With Tofersen

Start date: November 8, 2022
Phase: N/A
Study type: Interventional

The primary objective of this study is to document and describe the effects of a personalized rehabilitation program for patients with SOD1 ALS participating in the tofersen expanded access program. Participants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy. Participants will have an initial assessment performed and an individualized rehabilitation program will be prescribed. Each participant is encouraged to follow the prescribed recommendations that will include scheduled outpatient therapy sessions, functional assessments, and/or a home-based rehabilitation program. Functional assessments will be done at a minimum of every three months.

NCT ID: NCT05724173 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Start date: March 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.