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NCT ID: NCT04858555 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Staging System in Amyotrophic Lateral Sclerosis

Biostaging
Start date: December 2, 2022
Phase:
Study type: Observational

Recently two staging systems have been proposed for amyotrophic lateral sclerosis (ALS), based on clinical milestones The King's college clinical staging system (1) and ALS Milano-Torino Staging (ALS-MITOS) (2). Further research to validate and develop an accurate staging system in different populations will improve our understanding of its pathogenesis, disease activity and progression. General objective : To validate the two previously proposed staging system and to test the interest of considering Neurofilament biomarkers in these systems. Specific objectives: 1) To validate the two classification systems in an independent cohort of patients with ALS followed-up in the ALS expert center of Limoges (France) 2) To assess the interest of Nf biomarkers to predict neurological decline

NCT ID: NCT04857489 Recruiting - Clinical trials for Relapse Remitting Multiple Sclerosis

Deficient T Regulatory Cell (Treg) Function in Patients With Relapsing Remitting Multiple Sclerosis

Start date: June 1, 2020
Phase:
Study type: Observational

The purpose of this research is to find out how the T regulatory (Treg) cells control autoimmune response in multiple sclerosis. The investigators will identify Treg molecular markers and changes in function in patients with relapse remitting multiple sclerosis (RRMS). The investigators plan to study T regulatory immune cells in the blood of RRMS patients and control subjects to examine how Treg immune cells' deficient function may be involved in the development of mulitple sclerosis.

NCT ID: NCT04856384 Recruiting - Multiple Sclerosis Clinical Trials

Effect of Variance on Error Correction During Coupling

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This study is a case-control study, involving persons with progressive multiple sclerosis and healthy controls. The study contains 1 descriptive and 3 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, with period and phase auditory manipulations. In the latter twp sessions, apart from outcome measures of synchronization the following will be collected as well: brain activity using EEG recordings, spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

NCT ID: NCT04843813 Recruiting - Multiple Sclerosis Clinical Trials

Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-

LuMES
Start date: March 26, 2021
Phase: N/A
Study type: Interventional

The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.

NCT ID: NCT04837365 Recruiting - Multiple Sclerosis Clinical Trials

Impact of Neuropsychological Disorders in Multiple Sclerosis

SEVISEP
Start date: May 21, 2021
Phase: N/A
Study type: Interventional

The study involves MS patients with and without neuropsychological disorders. The patient will benefit from: - A routine neuropsychological assessment, including a cognitive and emotional assessment - A clinical examination - A three-dimensional analysis of movement

NCT ID: NCT04837352 Recruiting - Multiple Sclerosis Clinical Trials

Therapeutic Adherence of Multiple Sclerosis Patients

FELSA-SEP
Start date: January 18, 2022
Phase:
Study type: Observational

The goal of this study is to assess the role of sociocognitive and interpersonal factors in the therapeutic adherence of multiple sclerosis patients. This study will provide a better understanding of the socio-psychological issues associated with different types of non-adherence to treatment, and identify the risk factors and vulnerability of each patient.

NCT ID: NCT04832269 Recruiting - Multiple Sclerosis Clinical Trials

Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and Behaviour

MS-Children
Start date: October 19, 2020
Phase:
Study type: Observational

Introduction: Fetal exposure to glucocorticoids (GCs) used to induce fetal lung maturation in women threatened by premature labour is known to induce aberrations in brain development and stress sensitivity, cognitive dysfunction and neuro-psychiatric disorders in later life which all predict early brain ageing. Another common source of fetal GC exposure is the treatment of relapses in multiple sclerosis (MS), the most common neurological disease in young women. Despite the lack of studies, the 300-fold higher dosage of GCs for MS relapse treatment compared to obstetric indications is considered harmless for the fetus . Objectives: To examine the effects of GCs for MS relapse treatment during pregnancy on offspring structural and functional brain development, stress sensitivity, and cognitive and behavioural performance. Methods: Epidemiological multi-centre cohort study in 80 children and adolescents aged 8 to 18 years whose mothers received GCs to treat a MS relapse during pregnancy compared to unexposed participants. Expected Impact: Creating a guideline-changing evidence-based risk-benefit assessment regarding benefits of the MS relapse therapy for the mother and potential harm to the child.

NCT ID: NCT04821596 Recruiting - Multiple Sclerosis Clinical Trials

Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis

Clad'Action
Start date: July 13, 2020
Phase: N/A
Study type: Interventional

The main objective of the project is therefore to study and thus better understand the immunomodulatory / anti-inflammatory effects of cladribine during multiple sclerosis. Most current and developing therapies targeting the immune system have no effect on the progressive phase of MS, during which neurodegeneration plays a predominant role. As mentioned above, the very promising results of clinical trials with cladribine tablets for the early and progressive phase of the disease have revealed immunomodulatory properties and suggested potential neuroprotective effects. It therefore plans to further dissect one of these two parameters by designing in vitro studies with peripheral blood mononuclear cells (PBMC) from healthy donors and MS patients.

NCT ID: NCT04820478 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS)

KETO-ALS
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Weight loss is a known negative prognostic factor in amyotrophic lateral sclerosis (ALS). One potential mechanism of weight loss in ALS is a disturbance of the mitochondrial complex I which causes an energy deficit in affected cells. Over the last years, various interventional studies targeting the energy deficit in ALS yielded promising results; however,it is still unclear which kind of nutrition or nutritional supplement is most beneficial. Ketone bodies represent a logical therapeutic option in ALS as ketone bodies are an extremely high-energetic substrate which yields the double amount of adenosine triphosphate (ATP) per mole compared to glucose. The human liver is able to synthesize ketone bodies (beta-hydroxybutyrate, acetone, and aceto-acetate) from fat in times of glucose shortage, for example after a prolonged period of fasting. This metabolic shift is the underlying principle of the ketogenic diet, a carbohydrate-free, fat-rich diet which has been successfully tested in other neurodegenerative diseases such as Alzheimer's and Parkinson's disease. In the ALS mouse model, a ketogenic diet was associated with a slower decline of motor function. However, a ketogenic diet is difficult to implement in ALS as it requires a long-term change of eating habits, which is difficult to achieve due to progressive dysphagia, fast worsening of general condition, and limited survival. Therefore, the direct administration of ketone bodies yields a more realistic alternative in ALS as it is easy to apply and allows to maintain the usual eating habits. In this study, we hypothesize that the administration of 3 x 10 g beta hydroxybutyrate ester per day (in addition to normal food intake and the standard medication of 2 x 50 mg riluzole) slows down disease progression as measured by neurofilament light chains (NfL) in serum after 6 months compared to placebo. Power calculation relies on the results of the lipids and calories for ALS (LIPCAL-ALS) study which tested the effect of a high-caloric fatty nutritional supplement in ALS. The study revealed that NfL serum values declined significantly in the intervention group while remaining stable in the placebo group over the course of the study. Assuming a similar effect size for ketone bodies, we calculated that 76 patients had to be included in the current trial.

NCT ID: NCT04819737 Recruiting - Clinical trials for Multiple Sclerosis (MS)

Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

Start date: July 18, 2022
Phase: N/A
Study type: Interventional

This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.