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Nervous System Diseases clinical trials

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NCT ID: NCT05839795 Recruiting - Stroke Clinical Trials

Evaluation of Musculoskeletal System in Caregivers of Rehabilitation Patients

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

In this study, musculoskeletal-related pain, posture, spine function, the condition of the low back and neck regions, musculoskeletal system disorders, fatigue, and quality of life will be examined in caregivers of rehabilitation patients.

NCT ID: NCT05834855 Recruiting - Multiple Sclerosis Clinical Trials

Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS

Noisy Rebels
Start date: April 2023
Phase: Phase 3
Study type: Interventional

Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS. An advantage of rituximab is a considerably lower price. Therefore we will start a study aimed at demonstrating non-inferiority of rituximab compared to ocrelizumab in RMS. If non-inferiority of rituximab can be shown, important reductions in the cost of treatment of RMS will be possible, without loss of efficacy. Objective: Evaluating the efficacy and safety of ritixumab compared to ocrelizumab in the treatmens of RMS. Study design: Randomized double blind multi-centre non-inferiority study of rituximab compared to ocrelizumab in 200 patients with RMS. The trial duration will be 30 months Study population: The study population consists of 200 adult RMS patiens with an indication to start anti-CD20 monoclonal antibody treatment. Intervention: Patients will be randomized 1:1 into the standard group (ocrelizumab treatment) or the experimental group (rituximab treatment). Main study parameters: To conclude non-inferiority of rituximab there will be one primary endpoint: the proportion of patients free of inflammatory disease activity (defined as: new or enlarged T2 lesions) between week 24 (M6) and week 96 (M24) of treatment in each arm. Secondary trial endpoints are presence and number of clinical relapses,T2 and contrast enhancing lesion volumes, brain volume and brain volume changes, disease progression (defined as clinically relevant change on any of the measures: EDSS, T25FW, 9HPT, SDMT), biochemical parameters such as lipidomics and neurofilament light (NfL), immunological parameters, safety as measured by the number of (serious) adverse events ((S)AE), quality of life (EQ-5D-L) and treatment satisfaction (TSQM) and patient reported measures of MS impact (MSIS-29) and well-being (questionnaire on physical complaints) Nature and extent of the burden and risk: Patients included in this study will be treated and monitored by MRI, clinical tests and laboratory tests according to existing protocols and will not be exposed to extra or unknown risks. They will have extra annual questionnaires and larger blood samples at some time points. There is extensive experience with both rituximab and ocrelizumab as efficacious and safe treatments of RMS.

NCT ID: NCT05830981 Completed - Clinical trials for Neurological Disorders

Valproic Acid Use in Patients With Neurological Disorders

Start date: January 1, 2015
Phase:
Study type: Observational

Sodium valproate is a well-known anticonvulsant used in the treatment of epilepsy and bipolar disorder, as well as other psychiatric conditions requiring the administration of mood stabilizers. Aim of the present study is to assess sodium valproate usage among patients with neurological disorders. Prescriptions of 600 patients from out-patient pharmacy of neurology department at Mansoura university teaching hospital were analyzed in a retrospective prospective observational study which conducted between January 2015 and December 2017. Data collected include: demographic data, medical history, drug-drug interaction, polypharmacy, medication error, doses and therapeutic duplication. A designed and structured form was used to collect the required information.

NCT ID: NCT05826626 Recruiting - Stroke Clinical Trials

Investigating Neurocognitive, Motor and Biological Effects of MindLenses Professional in Neurological Diseases

MindLensesN
Start date: October 5, 2021
Phase: N/A
Study type: Interventional

This study aims to explore the effects of the treatment with MindLenses Professional device on cognitive and motor performances,as well as on the levels of a neurotrophic factor implied in brain plasticity, that is the brain derived neurotrophic factor (BDNF), in neurological patients. A further aim of the study is to evaluate if the treatment's efficacy could depend on specific characteristics of brain alteration (lesion vs atrophy). The treatment combines prismatic adaptation with serious games for cognitive training, for a total of 10 sessions. 30 patients with stroke and 30 patients with Mild Cognitive Impairment will be enrolled.

NCT ID: NCT05826548 Recruiting - Stroke Clinical Trials

Financial Abilities in Neurological Diseases. Development of a Telerehabilitation Program: FINAGE

FINAGE
Start date: March 11, 2021
Phase: N/A
Study type: Interventional

Financial Abilities (FA) are a set of capacities that allow a person to independently manage her/his financial affairs in a manner consistent with personal self-interests and values. This project will: a) assess Financial Abilities in different neurological conditions: Mild Cognitive Impairment, Parkinson's disease and Stroke patients; b) investigate both cognitive correlations, specifically the role of executive functions, thought to be critically involved in the FA multi-dimensional concept, and neuro-anatomical correlates of Financial Abilities; c) build a rehabilitation tool in order to improve FA. Secondary aims are to apply this rehabilitation tool at long distance and evaluate its behavioral, functional and neuroanatomical effects. The starting point for this project is the recently published NADL-F - Numerical Activities of Daily Living - Financial, a multi-domain ecological battery aimed at assessing FA in healthy people as well as in neurological patient populations

NCT ID: NCT05822557 Completed - Stroke Clinical Trials

Bolus Pouch Feed Study

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

The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.

NCT ID: NCT05821257 Completed - Multiple Sclerosis Clinical Trials

Arm Swing During Walking in Early Multiple Sclerosis

Start date: December 1, 2021
Phase:
Study type: Observational

Multiple sclerosis (MS) is the most common central nervous system inflammatory demyelinating disease which causes motor and sensory deficits, cerebellar symptoms, and balance problems. Due to these symptoms, gait abnormalities are common in MS, even in patients with low degrees of impairment. The upper limb has an important role on postural control and gait stability. Affected arm swing movement and asymmetry during gait are common in neurological disorders such as Parkinson's disease (PD) even in early stages of the disease and arm swing treatment has been acknowledged to enhance gait and normalize arm swing in individuals with PD. The presence of arm swing changes during walking in MS patients, similar to PD, especially in the early period, may be an indicator of balance problems, this was, however, not investigated as such. Therefore, the aim of the current study is to assess the arm swing during gait in people with MS shortly after their diagnosis in early MS.

NCT ID: NCT05820074 Recruiting - Parkinson Disease Clinical Trials

Investigating Neural Biomarkers for Gait in Parkinson's Patients

Start date: April 13, 2023
Phase:
Study type: Observational

This observational study's main goal is to learn more about the neural mechanisms during movement in Parkinson's disease. Furthermore, it aims to inspire personalised treatment options. Participants will undergo a protocol that involves walking and gait-related motor tasks, such as seated stepping. During the protocol, brain activity will be recorded.

NCT ID: NCT05819008 Recruiting - Stroke Clinical Trials

Remote Neuropsychological Assessment of Patients With Neurological Disorders and Injuries

Start date: March 10, 2023
Phase:
Study type: Observational

For the last decades, many aspects of human life have been altered by digital technology. For health care, this have opened a possibility for patients who have difficulties travelling a long distance to a hospital to meet with their health care providers over different digital platforms. With an increased digital literacy, and an aging population often living in the countryside, far from hospitals or other health care settings, an increasing need for digitalization of meetings between patients and health care personnel is inevitable. However, neuropsychological assessment is one sort of health care not possible to directly transfer into digital form. These evaluations are most often performed with well validated tests, only to be used in a paper-pencil form with a specially trained psychologist during physical meetings. The aim of this project is to investigate whether a newly developed digital neuropsychological test battery can be used to perform remote assessments of cognitive function in patients with neurological injuries and impairments. To this date, there are no such test batteries available in the Swedish language. Mindmore (www.mindmore.com) is a test system developed in Sweden, performing neuropsychological tests on a tablet, but still with the psychologist present in the room. This system is now evolving into offering the possibility for the patient to perform the test in their own home, using their own computer or tablet. The aim of the present research project is to validate this latter system (Mindmore Distance), using the following research questions: 1. Are the tests in Mindmore Distance equivalent to traditional neuropsychological tests in patients with traumatic brain injury, stroke, multiple sclerosis, Parkinson's Disease, epilepsy, and brain tumor? 2. Can the results from Mindmore Distance be transferred into neuropsychological profiles that can be used in diagnostics for specific patient groups? 3. How do the patients experience undergoing a neuropsychological evaluation on their own compared to traditional neuropsychological assessment in a physical meeting with a psychologist?

NCT ID: NCT05815836 Completed - Stroke Clinical Trials

Precision Medicine in Stroke

PROMISE
Start date: October 2013
Phase:
Study type: Observational

PROMISE aims at identifying novel diagnostic and prognostic circulating biomarkers for patients with acute stroke and at informing on crucial yet undetected pathophysiological mechanisms driving outcome after stroke by enriching all phenotypic information available from clinical routine with in-depth quantification of the circulating proteome and metabolome as well as other entities.