MACSiMiSE-BRAIN: Metformin add-on Clinical Study in Multiple Sclerosis to Evaluate Brain Remyelination and Neurodegeneration: a Phase II Placebo-controlled Randomized Clinical Trial
This clinical trial aims to demonstrate that metformin can prevent clinical disability in patients with progressive MS by stopping or slowing down neurodegeneration by enhancing endogenous remyelination. Patients will continue their DMT treatment: metformin or placebo will be used as add-on study treatment.
NCT05893225 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05893225/
The Effect of Home-Based Transcranial Direct Current Stimulation on Fatigue in Multiple Sclerosis
The available therapeutic strategies for Multiple Sclerosis (MS)-related symptoms are usually faced with limited efficacy and numerous side effects. Patients with MS frequently suffer from fatigue, affective symptoms, and cognitive deficits.
NCT05890885 — Fatigue in Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/fatigue-in-multiple-sclerosis/NCT05890885/
Feasibility and Initial Efficacy of a Wheelchair Exercise-training Intervention for Persons With Multiple Sclerosis
The goal of this randomized controlled clinical trial is to examine the feasibility and initial efficacy of undertaking and delivering a novel, stakeholder-informed exercise training program for wheelchair users with multiple sclerosis. The main questions it aims to answer are: - Is the study feasible as measured by participant recruitment (24 participants total), retention (80%), and safety (adverse events)? - Is the study acceptable as measured by participant satisfaction and perceptions using an evaluation survey and semi-structured interviews? - Is there significant change in following the 16-week study in metabolic health outcomes, MS symptoms, and exercise behavior change? Participants will be randomized to complete the 16-week SPIN exercise training program or WellMS attention/contact wellness program. Researchers will compare the SPIN and WellMS groups to determine if there is a significant difference in metabolic health outcomes, MS symptoms, and exercise behavior change.
NCT05888727 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05888727/
The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality: A Controlled Study
The objective of this study is to investigate the effect of the level of hand fatigability on general fatigue and functionality by comparing Relapsing-Remitting Multiple Sclerosis individuals with age and sex-matched healthy individuals. 23 RRMS and 23 healthy people (mean age 40.08, 21 females, mean time since diagnosis 9.43 years, mean Expanded Disability Status Scale 3.23) were included in the study. To examine participants' fatigability level; for gross and pinch-grip Dynamic and Static Fatigue Index, for manual dexterity and functionality level Scale for the Assessment and Rating of Ataxia (SARA), Nine Hole Peg Test (NHPT) and Dexterity Questionnaire-24 (DextQ-24) were used. While Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS) were used to examine general fatigue, Beck Depression Inventory (BDI) was used to assess emotional status. The mean age of healthy individuals with RRMS was 40.08 ± 9.81 years, and the EDSS means of individuals with RRMS was 3.23 ± 1.47. 21 of both groups were female and 2 were male. It was determined that the difference between MS individuals and healthy individuals' SARA, NHPT, FSS and FIS averages, initial and final strength values was statistically significant (p≤0.05), and the decrease in force in individuals with RRMS was higher than in healthy individuals. However, there was no difference between RRMS and healthy individuals in terms of fatigability levels examined with the Dynamic and Static Fatigue Index (p>0.05). While the relationship of Static and Dynamic Fatigue Index with FSS and FIS was not statistically significant, the relationship was significant with DextQ-24's dressing, daily activities and TV/CD/DVD subsections (p<0.05). In individuals with early RRMS, there is a decrease in the repetitive (dynamic) and continuous (static) contractions of the rough and pinch grip strength, and this decrease is related to the negative impact on the daily living activities and functionality of the individuals. In particular, motor fatigue should be addressed from the early stages of rehabilitation programs that will be planned to maintain the active participation of individuals with RRMS in their daily living activities. To show motor fatigue with indices, further studies with different fatigue indices and individuals with RRMS at different EDSS levels are needed.
NCT05880745 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05880745/
The Neural Underpinnings and the Impact of Wearable Sensory Stimulation During Split-belt Treadmill Adaptation in People With Multiple Sclerosis
Majority of people with multiple sclerosis experience difficulty with balance and mobility, leading to an increased risk of falls. The goal of this clinical trial is to learn about brain activity during walking adaptation in people with multiple sclerosis. Also, this clinical trial will test a form of nerve stimulation to see if it can improve walking performance. The main questions it aims to answer are: - What areas of the brain are the most active during walking adaptation? - Can nerve stimulation make walking adaptation more effective? Participants will walk on a treadmill where each leg will go a different speed which will create walking adaptation. At the same time, brain scans will occur. There will be two sessions of walking adaptation, one with nerve stimulation, and one without nerve stimulation. Researchers will compare people with multiple sclerosis to healthy young adults to see if there are differences in brain activity.
NCT05878873 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05878873/
Exergaming With Immersive Virtual Reality to Improve Functional Abilities in People With Multiple Sclerosis
TITLE: Exergaming with Immersive Virtual Reality for people with Multiple Sclerosis INTRO: Multiple Sclerosis (MS) is an autoimmune and chronic neurodegenerative pathology caused by loss of the myelin sheath in the nervous system, causing motor, cognitive, behavioral and sensory symptoms. Conventional physiotherapy often includes exercise therapies, based on repetitive performances that can sometimes be unmotivating for patients. Immersive Virtual Reality could offer programs based on exercise (exergames) that are motivating, as well as appropriate to the therapeutic objectives of the target group. This tool has already been successfully tested in other groups (post stroke, Parkinson's,...) with promising results. Our ExeRVIEM project (Exergaming with Immersive Virtual Reality in Multiple Sclerosis) represents a new strategy to improve functionality in people with MS, using an exercise program with Virtual Reality glasses. HYPOTHESIS: The practice of the ExeRVIEM protocol based on physical function training in people with MS contributes to the maintenance and improvement of functional capacities, reducing the number of falls and increasing their personal autonomy. GENERAL OBJECTIVES: 1.1 Design and implement an ExeRVIEM exercise program/protocol to improve balance in older people 1.2 Analyze the effects of this ExeRVIEM program/protocol, in the short and medium term in people who attend an Association of patients. 1.3 Identify if there is a relationship between the variables that induce frailty and functional dependence and the ExeRVIEM protocol. SPECIFIC OBJECTIVES: 2.1 Determine and apply the ExeRVIEM protocol to explore differential effects for 6 minutes a day (2 days a week for 8 weeks). 2.1.1 Improving the functional independence and mobility of people by improving balance, reducing the risk of falls and the correct development of activities of daily living. 2.1.2 Gait improvement. 2.1.3 Improved functionality. 2.1.4 Improving grip strength. 2.1.5 Improving reaction times. 2.1.6 Improving the perception of fatigue 2.2 Determine the influence of parameters related to exposure to RVI. 2.2.1 Safety of the virtual reality exhibition 2.2.2 Usability of the virtual reality exhibition 2.2.3 Personal experiences and satisfaction of the virtual reality exhibition METHODS: Design: Randomized controlled trial. People diagnosed with MS who attend the AVEMPO VIGO center in Spain on a regular basis will be invited to participate in the study. After they meet the selection criteria, they will be assigned to an experimental group and a control group. Information on the sociodemographic characteristics and a clinical history of the participants will be collected. Intervention: Two groups (experimental and control). The experimental group will carry out the ExeRVIEM protocol sessions (6 min) focused on the upper and lower limbs. (2 sessions per week for 8 weeks). All sessions will begin with a warm-up focused on stimulating coordination and joint mobilization, so that the body is predisposed both centrally and peripherally to carry out the session and will end with a stretching routine accompanied by breathing calm and controlled cycles. The session will be supervised by the center's physiotherapist or occupational therapist. The control group will continue with the usual activities proposed by the center team. Evaluations: 3 evaluations will be carried out: initial, final (at 8 weeks) and follow-up (one month after the end of the program). The contents of the evaluations will be: Patient characteristics: "Ad hoc" record sheet that will include data on age, sex, years since diagnosis, MS subtype, and drug treatment. 1. ExeRVIEM protocol. Safety (Simulator Sickness Questionnaire), Usability (System Usability Scale) and personal experiences (Game Experience Questionnaire and "ad hoc" interview notebook) 2. Balance, gait and risk of falling (Tinetti Test) 3. Functional mobility and lower limb strength (Five times sit to stand test) 4. Functional autonomy (Timed Up and Go Test- simple and cognitive) 5. Fatigue (Fatigue Severity Scale) 6 Handgrip (dynamometer) 7. Reaction time (Rezzil Software) Hypothesis: Our findings aim to support the use of new health technologies in the field of rehabilitation and medical care for people with MS, achieving a feasible and safe Immersive Virtual Reality exergaming program.
NCT05870254 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05870254/
Care Technology to Ascertain, Treat, and Engage the Community to Heal Depression in Patients With Multiple Sclerosis: Closing the Gaps in Depression Care for People With MS By Closing the Information Loop
The researchers want to find out if an electronic application called MS CATCH can enhance patients' and doctors' experiences during and in between clinical visits. MS CATCH is a smartphone-based tool which allows patients to enter their mood related symptoms at regular intervals, which is then available to their Neurologist in their electronic medical record. The neurologist is also able to view additional information from their medical record, and receives alerts for changes reported by the patient that raise concern for the patient's mental health.
NCT05865405 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05865405/
Effects of Physical Therapy and Dalfampridine on Functional Mobility and Lower Extremity Strength in Non Ambulatory Persons With Multiple Sclerosis
The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with multiple sclerosis. The main question[s] it aims to answer are: 1. Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone 2. Does Physical Therapy improve functional outcomes in patients who are non ambulatory
NCT05859802 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05859802/
The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP 2)
The goal of this clinical trial is to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit stimulation in Multiple Sclerosis patients with spasticity. The main questions it aims to answer are: - to evaluate the short-term impact of EXOPULSE Mollii suit on balance in adult MS patients suffering from spasticity. - to assess the effects of EXOPULSE Mollii suit on mobility, upper and lower limbs muscle tone, pain, fatigue and quality of life. Participants will participate in: - One baseline visit for inclusion during which the patient will undergo the first session (active or sham) along with evaluations (before and after the session) - One visit after two weeks during which the patient will undergo the second session (active or sham) along with evaluations (before and after the session) - One visit after two weeks of the second stimulation condition; the patients will undergo a third evaluation and receive the EXOPULSE Mollii Suit for the four-week open label phase and will use the suit at home for an active stimulation session every other day for four weeks. - One visit at the end of the open label phase to perform the fourth and last evaluation and return the EXOPULSE Mollii suit. Researchers will compare both Active and Sham groups to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit.
NCT05857280 — Spasticity, Muscle
Status: Recruiting
http://inclinicaltrials.com/spasticity-muscle/NCT05857280/
Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
This prospective case series will use mixed methods to examine the feasibility, acceptability, and initial effects of three telehealth cognitive behavioral therapy components (relaxation training, behavioral activation, cognitive therapy) for fatigue in people with multiple sclerosis.
NCT05848323 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05848323/