An Observational Study to Evaluate Immune Response to Covid-19 Vaccines, Infections and Immune Treatments in People With Multiple Sclerosis
Coronavirus (Covid-19) has affected millions of people worldwide. Vaccines to prevent Covid-19 infection have been offered to reduce the risk of infection. While these vaccines have been offered to people with multiple sclerosis (MS), they have not been tested in these individuals. It is uncertain whether people with MS will develop protective antibodies after a Covid-19 vaccination and how long these antibodies will last. The investigators are planning to study the immune response to the full course of Covid-19 vaccine in people with MS (study group) and compare this to people without MS or immune suppression (control group).
NCT05269888 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05269888/
Exploring Cortical Remyelination in Children With Multiple Sclerosis
Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.
NCT05258396 — Children With Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/children-with-multiple-sclerosis/NCT05258396/
Optimizing Detection and Prediction of Changes in Cognitive Function in Multiple Sclerosis
The researchers will use technology-assisted ambulatory assessment techniques to examine cognitive dysfunction in people with Multiple Sclerosis (MS). The researchers will determine if ambulatory assessments are sensitive to subtle declines in cognitive functioning. They will also explore the impact of modifiable factors, such as sleep, physical activity, mood, and somatic symptoms on cognitive function. These efforts will uncover behavioral and medical intervention methods. Finally, they will explore whether variability in cognitive functioning predicts short- and long-term changes in other patient-centered functional domains, social participation and physical functioning.
NCT05252195 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05252195/
Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis
The investigators want to evaluate gynecological follow-up concerning patients with multiple sclerosis. This study will include reproductive women (from 18 to 40 years old). Patients in the study have an aftercare at the neurology department at Pellegrin Hospital (Bordeaux).
NCT05248438 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05248438/
The Effect of Iyengar Yoga Practice on Patients With Multiple Sclerosis
The aim of this work is to find out what effect the practice of Iyengar yoga has on patients with multiple sclerosis on the EDSS 5 and more, specifically in the field of mobility, self-sufficiency and anxiety.
NCT05247372 — Multiple Sclerosis, Iyenagar Yoga, Yoga, EDSS
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis-iyenagar-yoga-yoga-edss/NCT05247372/
Effects of Ozanimod on Immune-mediated Mechanisms of Neurodegeneration in Multiple Sclerosis - a Preclinical Study
This is a prospective non interventional study including patients with Relapsing-Remitting Multiple Sclerosis (RRMS) or with Neuromyelitis Optica Spectrum Disorders (NMOSD) and healthy subjects, who are enrolled within the routinely programmed clinical examinations at the IRCCS Neuromed (Pozzilli, Italy), IRCCS Polyclinic Hospital San Martino (Genoa, Italy) and Sant'Andrea Hospital - University of Rome La Sapienza (Rome, Italy). Specifically, the study investigates how ozanimod may contrast neurodegenerative mechanisms triggered by both arms of the adaptive immune response (T and B cells) and by their suboptimal regulation in MS. Overall, the project aims at assessing by in vitro experiments (there will be no patients on treatment with ozanimod and the drug will be only used in vitro): AIM1: ozanimod ability to modulate the synaptotoxic effect of T-cells derived from patients with MS relapse in a MS-chimeric ex-vivo model and to identify possible mediators (IRCCS Neuromed-Pozzilli, in collaboration with Synaptic Immunopathology Laboratory Dep. Systems Medicine, Tor Vergata University of Rome); AIM2: ozanimod ability to reduce the cytokine-mediated breakdown of the BBB and the migration of the here studied immune cells through ex vivo models of BBB (IRCCS Polyclinic Hospital San Martino); AIM3: ozanimod ability to affect the migration properties of Epstein Barr virus (EBV) infected B cells in MS (Sant'Andrea Hospital); AIM4: ozanimod ability to modulate the number and/or function of regulatory T cells (Treg), a lymphocyte population playing a key role in the control of pathogenic adaptive immune responses (Treg Cell Laboratory, Università degli Studi di Napoli "Federico II", Naples, Italy, receiving blood samples from Neuromed Hospital and Sant'Andrea Hospital; not recruiting unit). The work of the four labs is conceptually and operationally integrated: the labs at IRCCS Neuromed-Pozzilli/Tor Vergata University (Aim1) and at Polyclinic Hospital San Martino (Aim2) will investigate the effects of ozanimod on well-known mechanisms of damage in MS, inflammatory synaptopathy and BBB damage and immune cell migration. The lab at Sant'Andrea Hospital (Aim3), will verify whether B cells infected by different EBV genotypes are involved in BBB migration, and how ozanimod may interfere with this mechanism. The Treg Cell Laboratory (Aim4) will investigate whether ozanimod can also act "upstream" of these mechanisms by regulating the adaptive immune response.
NCT05245344 — Healthy
Status: Not yet recruiting
http://inclinicaltrials.com/healthy/NCT05245344/
Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) Versus CinnoVex® (CinnaGen) in Reducing the Annualized Relapse Rate in Participants With Relapsing Remitting Multiple Sclerosis: A Phase III, Randomized, Parallel, Noninferiority Study
The purpose of this study is to evaluate the efficacy and safety of peginterferon beta-1a produced by CinnaGen compared with CinnoVex® (CinnaGen) in subjects with relapsing remitting multiple sclerosis (RRMS). All the participants will receive one of the following regimens: pegylated interferon beta-1a (CinnaGen), autoinjector (Physioject™), 125mcg, subcutaneous, every 2 weeks for 24 months or CinnoVex® (CinnaGen), prefilled syringes, 30mcg, intramuscular, once a week for 24 months. The primary objective of this study is to verify the non-inferiority of peginterferon beta-1a (CinnaGen) versus CinnoVex® (CinnaGen) in reducing the annualized relapse rate (ARR) in participants with relapsing remitting multiple sclerosis (RRMS) at 2 years. The secondary objectives of this study are: - Reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans - Slowing the progression of disability - Comparing adverse events
NCT05242133 — Relapsing Remitting Multiple Sclerosis (RRMS)
Status: Completed
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis-rrms/NCT05242133/
The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis With Impaired Balance and Mobility
There is ample evidence that regular exercise can reduce MS specific symptoms and improve health and wellbeing in people with MS. However, for people with MS to engage in exercise activities long term, it is important that they are offered a range of exercise opportunities that are safe, feasible and potentially effective to reduce MS symptom. This will allow people to select an activity they enjoy, is adapted to their needs and thus are more sustainable long-term. Frame Running (FR) provides an opportunity for people with walking and balance problems to walk or run safely without the risk of falling. The frame consists of three wheels and has a saddle and handlebars like a trike without pedals. The proposed mixed methods study aims to examine the feasibility and acceptability of FR as a sustainable aerobic exercise option for people with MS and the feasibility of conducting a future definite trial into the impact of FR on functional mobility, fatigue, cardiorespiratory function and psychosocial outcomes. People who experience problems with their walking and/or balance will be eligible to take part in this study which consists of a 12 weekly group FR training sessions led by a qualified coach. FR training attendance, recruitment, retention, outcome measure completion and adverse events will be recorded and the participant views on the feasibility, acceptability and impact of FR will be explored through the use of focus groups. Physical function, physical activity and psychosocial outcomes will be assessed at baseline, 6 and 12 weeks.
NCT05234879 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05234879/
3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)
The aim of this study is to compare the 3D OPTIMIZED MPRAGE WMN sequence to "conventional sequences" used in spinal cord analysis. The patients will be explored at the cervical level with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 2D sagittal PSIR, 3D T1 MPRAGE sequences, and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE and 3D axial OPTIMIZED WMN MPRAGE. At the thoracic level, with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 3D T1 MPRAGE sequences and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE.
NCT05227092 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05227092/
Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
Emotional support following Multiple Sclerosis (MS) diagnosis is not part of the current service provision. However, research has identified a need for this as poor adjustment to diagnosis has been linked to higher levels of psychological distress. A previous study, named 'Providing Emotional Support Around the Point of MS Diagnosis' (PrEliMS), explored how best to provide support. People with MS completed a self-help workbook, alongside receiving support from MS nurses. The workbook is based on a psychological therapy called Acceptance and Commitment Therapy and was developed through focus groups of people with MS, relevant stakeholders, and clinical expertise. In this study, issues were found with parts of the workbook content and delivery. Nurses found it difficult to facilitate this alongside their usual MS Nurse care and felt psychological distress was not within their remit. In this study, the investigators will - explore how effective the PrEliMS workbook is at reducing distress from MS diagnosis, when delivered by a Psychology Practitioner (Trainee Clinical Psychologist) - compare delivery by a Psychology Practitioner with the data from the Nurse delivered PrEliMS trial to explore which is more effective - revise the workbook based on feedback from participants and what was learnt from the PrEliMS feasibility trial, to improve patient experience. The investigators will recruit seven people from an MS clinic who have received an MS diagnosis in the last 6-months and consent to taking part. Participants will meet with a Psychology Practitioner (over the phone or online) once a week for four weeks, alongside completing the workbook. The investigators will also ask participants to complete questionnaires to examine their levels of psychological distress. Interviews will then be conducted to get feedback for refining the workbook. The procedure will then be repeated with the refined workbook and seven newly recruited participants. The overall study will last a year
NCT05225012 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05225012/