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Multiple Sclerosis clinical trials

View clinical trials related to Multiple Sclerosis.

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NCT ID: NCT06136728 Not yet recruiting - Multiple Sclerosis Clinical Trials

Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis

AmpPT
Start date: January 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone. The main questions this study will answer are: - Does combining dalfampridine with physical therapy improve mobility more than physical therapy without concurrent dalfampridine? - Is the combined treatment associated with better outcomes than the medication (dalfampridine) on its own? - How do the individual treatments (dalfampridine, physical therapy) alone compare to each other? Participants with MS-related mobility deficits will: - Receive 6 weeks of dalfampridine treatment to assess the effects of this treatment. - After stopping the medication for 2 weeks, the investigators will re-evaluate walking, then randomly assign individuals to a 6-week physical therapy program. - Half of the participants will receive physical therapy while resuming dalfampridine treatment. The other half of the participants will receive physical therapy without resuming the medication. Researchers will compare the combination treatment group (medication plus physical therapy) to the physical therapy only group to see if the combined treatment improves walking-related function. Approximately 3 months after finishing the physical therapy program, participants will undergo a final evaluation to see if the treatment effects have been maintained.

NCT ID: NCT06112639 Not yet recruiting - Clinical trials for Neurocognitive Dysfunction

The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders

DANCEREX-DTx
Start date: January 8, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a new digital therapeutic solution which combines a holistic, multidimensional rehabilitation program based on dance and music with an innovative motivational system (DANCEREX-DTx) in Chronic Neurological Disorders (Multiple Sclerosis and pre-Mild Cognitive Impairment - MCI/ MCI at risk of Alzheimer's Disease). The main questions it aims to answer are 1] efficacy of the digital therapeutic solution in terms of adherence, clinical/functional measures, quality of life and surrogate measures; 2] usability and acceptability of the system. Participants will be randomized (with an allocation ratio of 2:1:1) into the experimental group (DANCEREX - 12 sessions of multidimensional dance-based program integrated with an innovative motivational system), active comparator group (12 sessions of multidimensional dance-based program) and placebo group (12 sessions of educational program). Researchers will compare the experimental group to other two groups to see if a digital therapeutic solution integrating a multidimensional dance-based program and motivational system is effective in increasing adherence to rehabilitation treatment.

NCT ID: NCT06110468 Not yet recruiting - Multiple Sclerosis Clinical Trials

Physical Function, Health and Employment for People With Multiple Sclerosis

Start date: March 2024
Phase: N/A
Study type: Interventional

Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving levels of physical activity. The utility of the intervention will be investigated in terms of quality adjusted life years, long-term employment status and work-related costs.

NCT ID: NCT06090084 Not yet recruiting - Multiple Sclerosis Clinical Trials

Investigation of Factors Affecting Functional Capasity in Multiple Sclerosis

Start date: October 2023
Phase:
Study type: Observational

Functional exercise capacities of Multiple Sclerosis (MS) patients decrease with the effect of symptoms and sedentary lifestyle. A decrease in aerobic capacity may be manifested by a decrease in walking distance or speed, or by restriction in activities of daily living. Decreased aerobic capacity is associated with many factors such as increased risk of cardiovascular disease, decline in cognitive functions, and decreased health-related quality of life. In this respect, measurement of aerobic capacity is one of the important physiological measurements in terms of evaluating the existing functional status of individuals and preparing rehabilitation programs appropriately for individuals. According to studies in the literature, functional capacity in MS patients has been found to be associated with many individual and disease-related factors. However, studies on musculoskeletal and respiratory system factors that may affect functional capacity are insufficient in number. The aim of this study is to examine the effects of balance, core muscle strength, trunk muscle structure, lower extremity muscle strength, upper extremity functions, fatigue and respiratory muscle strength on the functional capacities of MS patients. Functional capacities of MS patients who met the inclusion criteria will be evaluated with the 6-Minute Walk Test, balance assessments with the Mini Balance Evaluation Systems Test, the strength of the core muscles with the pressurize biofeedback unit, the thickness of the trunk muscles by the Ultrasound Imaging Method, the muscle strength of the lower extremities with the 5 Times Sit to Stand Test, for upper extremity functions, grip strength will be evaluated with a hand dynamometer and Arm Functions Questionnaire in Multiple Sclerosis, fatigue with the Fatigue Severity Scale and respiratory muscle strength will be evaluated by measuring Maximal Inspiratory Pressure and Maximal Expiratory Pressure with an electronic pressure transducer. The cumulative effects of the parameters to be evaluated on functional capacity in MS patients will be examined by multivariate linear regression analysis and the cumulative total variance will be obtained in terms of R2. Investigation of musculoskeletal system factors that may affect functional capacity and determining which factor contributes more will benefit clinicians and researchers working in this field in terms of evaluating patients and establishing rehabilitation programs.

NCT ID: NCT06065670 Not yet recruiting - Clinical trials for Demyelinating Diseases

Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy

ReINFORCE
Start date: March 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with acute inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of acute demyelinating lesions. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577. This study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of acute demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination. In addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of acute lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination and compare it to the other assessments.

NCT ID: NCT06053749 Not yet recruiting - Clinical trials for Multiple Sclerosis (MS)

An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden

INFORM
Start date: September 2, 2024
Phase:
Study type: Observational

Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed. INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure. The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

NCT ID: NCT06025968 Not yet recruiting - Multiple Sclerosis Clinical Trials

Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis

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

The goal of this clinical trialis to compare a digital Cognitive-behavioral intervention for insomnia to digital administered applied relaxation in participants with Multiple Sclerosis. The treatments will be compared in following outcomes: - Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and early morning awakening (EMA). - Insomnia symptoms - Depressive symptoms - Client satisfaction - Negative effects - Worry - Fatigue - Quality of life - MS symptoms/function

NCT ID: NCT06020937 Not yet recruiting - Multiple Sclerosis Clinical Trials

Olfactory and Trigeminal Functions in Patients With Multiple Sclerosis: Case-control Study

Start date: October 30, 2024
Phase:
Study type: Observational [Patient Registry]

The sensation of smell is influenced by the somatosensory and chemesthetic sensati¬ons of the nose: for example, the cooling sensation of menthol or the prickle of carbon dioxide from carbonated drinks. These sensations are mediated in the nose by the trigeminal nerve and there is increasing evidence that trigeminal and olfactory functions are closely linked and potentially interdependent. In addition, trigeminal activation is crucial to the perception of nasal airflow. Some researchers speculate about the impact of trigeminal nerve on the entire olfactory sensation and about the presence of some specific "trigeminal cells" into the nose.Patients with Multiple sclerosis (MS) can suffer from quantitative olfactory disorders that generally are of light entity and do not interfere with daily life activities but it is important to underline that olfactory loss can be an onset sign of the MS. Considering the "trigeminal component" in the olfaction, because trigeminal nerve inflammation is quite common in MS patients due to central and peripheral inflammation, it could be possible that these patients suffer from changes in the quantitative, but more in the qualitative smell functions that are generally not identified because poorly investigated.

NCT ID: NCT06017726 Not yet recruiting - Multiple Sclerosis Clinical Trials

Insulin Resistance in Egyptian Patients With Multiple Sclerosis

IR-MS
Start date: January 2024
Phase:
Study type: Observational

The goal of this three-phase interventional study is to determine the prevalence of Insulin resistance in non-diabetic patients with multiple sclerosis in Egypt The main questions it aims to answer are: 1. what is the prevalence of insult resistance among Egyptian patients with Multiple sclerosis? 2. what are the effects of insulin resistance on multiple sclerosis disease activity and progression 3. what are the effects of treating insulin resistance on multiple sclerosis disease activity and progression participants with MS will be tested for IR to determine its prevalence, in the 2nd phase a group of MS patients with IR will be compared with another control group of MS patients without IR for clinical, laboratory, and radiological markers of disease activity and progression twice at baseline and after 1 year. in the 3rd phase, patients with IR will be divided into 2 groups one who will receive appropriate treatment for IR and the other group without treatment of IR and will be compared by the end of the 2nd year for clinical, laboratory and radiological markers of disease activity and progression

NCT ID: NCT06012513 Not yet recruiting - Sleep Disorder Clinical Trials

Sleep Disorders and Quality of Life in Patients With Multiple Sclerosis

Start date: September 2023
Phase:
Study type: Observational

1. To determine sleep disturbance in different types of multiple sclerosis. 2. To asses the effect of sleep disturbance on quality of life in patients with multiple sclerosis. 3. Correlation between sleep disturbance in different types of multiple sclerosis.