Validation of DigiCog (BCCAMS App) and Konectom™ Tools, for Supporting Digitalized Clinical Assessment of Cognitive and Motor Functions in Patients With Multiple Sclerosis. DigiToms Study
The primary objective of this study is to establish scores of Cognitive impairment (CI) of the 3 DigiCog [Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app] tests [Computerized Speed Cognitive Test (CSCT), Computerized Episodic Visual Memory Test (CEVMT) and the French Learning Test (FLT), a verbal memory test similar to the CVLT], using a tablet application in a sample of healthy participants matched to persons with MS (PwMS). The secondary objectives of this study are to determine the ability of the DigiCog app to detect cognitive impairment (CI) compared to the classical Brief International Cognitive Assessment for MS (BICAMS) in PwMS; to determine the relationship between depressive symptoms and cognitive performance in Multiple Sclerosis (MS) sample; to determine the relationship between subjective perception of CI and cognitive performance ; to evaluate the reliability of Konectom™ digital outcome assessments (DOAs) in healthy subjects (HS) and PwMS; to evaluate the convergent validity of Konectom™ digital outcome assessments (DOAs) against in-clinic conventional disability outcome assessments in PwMS; to evaluate differences in Konectom™ DOAs [self administered at home and in-clinic] between PwMS and HS; to evaluate the variability of Konectom™ DOAs self-administered at home in free-living environment in HS and PwMS; to compare Konectom™ DOAs between in-clinic supervised administration versus self-assessments in free-living environment in HS and PwMS; to evaluate the clinical meaningfulness of Konectom™ DOAs against Patient-Reported Outcomes (PRO) in PwMS.
NCT04756700 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04756700/
Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS): Extension of the DISCOMS Study
The Main Hypothesis of this extension trial is that among those who have successfully discontinued their DMT as part of the DISCOMS trial (i.e. did not have a new MS relapse or brain MRI lesion) and remain off DMT after DISCOMS are at no greater risk of new or worsened MS disease activity compared to those who successfully continued their DMT as part of DISCOMS and remain on DMT, each assessed at least one year after termination of the primary DISCOMS study.
NCT04754542 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04754542/
Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Multiple Sclerosis
The 3-m backward walk test (3MBWT) is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk and balance. The aim of our study was to reveal the test-retest reliability and validity of the 3MBWT in Multiple Sclerosis patients. Our study will be done as a "test-retest" design and psychometric properties of 3 m backward walking test in MS patients will be examined. Mini Mental State Examination, 3 m walk back test, Berg Balance Scale, Timed Up and Go, Timed 25 Step Walking Test and 4-Square Step Test will be applied to the patients. All evaluations will be made by the same physiotherapist. The second and third evaluation (retest) will be performed by the same physiotherapist two days after the first evaluation (test) and 2 weeks later to measure test-retest reliability. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations. The sample size, according to Lexell and Downham (2005), 40-50 participants should be included in reliability studies. Considering this recommendation, which defines the reliability of 3MBWT, it is planned to include 50 individuals with MS in our study.
NCT04753411 — Reliability and Validity
Status: Not yet recruiting
http://inclinicaltrials.com/reliability-and-validity/NCT04753411/
Impact of Core Performance on Functional Parameters in Multiple Sclerosis
Optimal trunk control relies on somatosensory, motor and musculoskeletal integrity, which is often damaged in multiple sclerosis (MS). Researches on postural control in people with MS (PwMS) have revealed that reduced somatosensory conduction may adversely affect some functions. PwMS have increased postural sway in upright posture than healthy people. They move closer and slower when reaching out or taking a step. Trunk controls are weak and postural responses are delayed. The activation of core muscles is very important for an effective trunk control. Because the core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. There are a limited number of studies in the literature showing that core stability is reduced in PwMS. Our knowledge about the effects of this reduction on function in PwMS is very limited.
NCT04750733 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04750733/
Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis
The primary objective of the study is to investigate neuroregenerative efficacy (proof of concept) of intrathecal treatment with autologous MSCs as measured by neurophysiological parameters in patients with progressive MS. Secondary objectives are to assess neuroregenerative efficacy as measured by other neurophysiological parameters as well as clinical, opthalmological and MRI modalities, and to assess safety of the treatment procedure.
NCT04749667 — Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04749667/
Upper Limb Assessment in Multiple Sclerosis: The Minnesota Manual Dexterity Test As A Measure Of Hand Function
The aim of the study is to report the results of manual dexterity using the Minnesota Manual Dexterity Test in people with Multiple Sclerosis.
NCT04721340 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04721340/
LUNA-EMG to Enhance Lower Limb Motor Functions in Multiple Sclerosis
The aim of the present study is to evaluate the effects of training performed with the LUNA-EMG system to enhance motor functions of the lower limb in multiple sclerosis. This is a randomized open-label trial. Patients will be randomized into the intervention group (LUNA-EMG, 30-45 minutes once a week for 12 weeks) or in the control group (standard care). The effect of the training will be measured based on the muscular strength, walking tests, proprioception and a quality of life questionnaire.
NCT04720898 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04720898/
Dynamic Balance Training in Multiple Sclerosis
This study will test a new technique for improving balance while walking in people with multiple sclerosis (MS). The technique focuses on having people with MS safely practice walking on simulated, uneven terrain that challenges balance and more accurately mimics walking in the community. The goal is to improve balance while walking in order to improve mobility and decrease the risk of falls. Recently, we developed a state-of-the-art treadmill system that allows us to create a challenging walking environment by placing a treadmill onto a motion base. We are able to simulate uneven terrain through movements of the walking surface while maintaining a safe walking environment. We will use this system to conduct tests of balance while walking and to train people to walk on uneven surfaces. Our objective is to evaluate the use of uneven terrain for training gait and balance in people with MS. Participants will undergo a four-week training protocol designed to disrupt and challenge balance while walking. We anticipate that training on uneven terrain will enhance gait stability, improve overall walking function and balance and increase balance confidence compared to training on a stable surface.
NCT04719494 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT04719494/
Effectiveness of a Novel Theory of Mind Training for People With Multiple Sclerosis: a Randomised Controlled Trial.
Theory of Mind (ToM) is the ability to understand and attribute mental states to ourselves and others. People with Multiple Sclerosis (pwMS) could present an impairment of this ability, with negative consequences on their social relationships and Quality of Life (QoL). We aimed to design and implement a novel ToM rehabilitation training, testing its efficacy on the promotion of emotional and mental states understanding, on QoL and on the alexithymia traits.
NCT04711941 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04711941/
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity
This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis.
NCT04711148 — Relapsing Remitting Multiple Sclerosis
Status: Active, not recruiting
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis/NCT04711148/