The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis
The main aim of the project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test administered according to the new Czech extended version manual in patients with multiple sclerosis.
NCT05012241 — Motor Activity
Status: Active, not recruiting
http://inclinicaltrials.com/motor-activity/NCT05012241/
Pregnancy Cohort in Multiple Sclerosis (MS)
Multiple sclerosis (MS) is a common inflammatory demyelinating disorder of the central nervous system frequently affecting females in their reproductive phase of life. In this prospective observational study, we obtain data on the outcome of pregnancies in MS patients and the influence of pregnancy on clinical, laboratory and MRI parameters in MS.
NCT05010902 — Multiple Sclerosis (MS)
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis-ms/NCT05010902/
DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) causing focal lesions of demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord, leading to physical and cognitive disability. The scientific community and patients are in need for new and more reliable biomarkers, especially biomarkers of disease progression in order to adapt therapeutic approaches on an individual level. Digital biomarkers have the potential to fill this gap allowing for quasi-continuous measures that might be more informative than episodically collected conventional data concerning the impact of the disease on activities of daily living. Using app-based challenges, continuous monitoring and surveys the Investigators aim to obtain data that can be used as digital biomarkers (DB). These digital biomarkers will provide more granular and precise assessments, thus complementing traditional diagnostic measures and techniques. After a first feasibility study (ClinicalTrials.gov: NCT04413032) a number of digital biomarkers have been identified as reliable, reproducible and meaningful to PwMS and are therefore being validated in a bigger cohort of PwMS with a longer follow-up within this validation study 1. Those digital biomarkers will be compared to state-of-the-Art clinical, imaging and body fluid assessment.
NCT05009160 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05009160/
Efficacy of Diet on Quality of Life in Multiple Sclerosis
The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.
NCT05007483 — Multiple Sclerosis, Relapsing-Remitting
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis-relapsing-remitting/NCT05007483/
A Teleheath tDCS Approach to Decrease Cannabis Use: Towards Reducing Multiple Sclerosis Disability
The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be recruited.
NCT05005013 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05005013/
Physiological Responses in Experimentally Induced Cognitive Fatigue in People With Multiple Sclerosis (MS): a Feasibility Study
The current study will add to the current knowledge by combining several electrophysiological techniques to examine the relationship between physiological responses and cognitive fatigue and daily activity performance in a stress- and fatigue-inducing protocol. The aims of this study are: 1) to evaluate the feasibility and usability of assessing physiological responses in an experimental set-up and 2) to investigate the association between physiological outcomes, experimentally induced stress and cognitive fatigue in people with multiple sclerosis (MS) and healthy controls.
NCT05003375 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05003375/
Differential Vulnerability of Individual Thalamic Nuclei: Toward New Biomarkers in Multiple Sclerosis
The thalamus is composed of several nuclei interlocked in a complex anatomy. In multiple sclerosis (MS), the thalamus can be altered due to disconnection by white matter lesions and due to direct damages that could be partly mediated by CSF. Due to such pathophysiology and complex anatomy, some nuclei could be more vulnerable to multiple sclerosis than others. We will test this hypothesis by using a new algorithm to automatically segment several nuclei that we will be applied to the French national MS database
NCT05002764 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT05002764/
The Influence of Cognitive Behavioral Therapy on Fatigue, Cognition and Inflammatory Biomarkers in Multiple Sclerosis Patients
There is a rising concern about quality of life of multiple sclerosis (MS) patients has emerged. Cognitive dysfunction with primary fatigue and there correlation to the level of disease inflammatory process has got great interest in MS research . The aim of the present study was to examine the influence of using a computer-based cognitive behavioral therapy on primary fatigue, cognitive dysfunction, and inflammatory biomarkers for patients with MS. Patients and methods A total of 40 MS patients (Expanded Disability Status Scale<5) were divided into two groups, both groups are suffering cognitive decline (using RehaCom software to assess attention/concentration, memory and reaction behavior) with primary fatigue according to the Fatigue Severity Scale (FSS>36). Patients with depression and sleep problems were excluded from the study. Patients in both groups have elevated serum levels of tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ). Patients in (G1) underwent conventional physical therapy program for MS including aerobic training, resistive training and a flexibility program, patients in (G2) underwent an intensive computer-based cognitive program for attention, concentration, memory and reaction behavior using the RehaCom software. The conventional physical therapy interventions for both (G1) sustained for three months, 45 minutes to 1 hour, 3 times/week. The computer-based cognitive behavioral therapy for patients in (G2) was prescribed as following (45 minutes to 1 hour a session, 3 times/week for continues three months).
NCT05002062 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT05002062/
Neurophysiological Estimates of Cortical Grey and White Matters Damage in Patients With Multiple Sclerosis
Main aim of this study will be the evaluation of the neurophysiological techniques of Transcranial Magnetic Stimulation (TMS) via electroencephalography (EEG) co-registration (TMS-EEG) with the study of TEPs (TEP: transcranial evoked potentials) as surrogates of white matter and grey matter functional integrity in patients with Multiple Sclerosis (MS). Data will be compared with those obtained from a group of healthy control subjects. Secondary aim will be the longitudinal evaluation of these neurophysiological parameters in MS patients during routine clinical and radiological evaluations, performed according to clinical practice, for 12 months. To this aim a longitudinal multicenter study will be carried out, interventional (for neurophysiological techniques) and observational (for clinical and radiological evaluations), which involves the enrollment of 64 patients diagnosed with MS. Patients will keep their usual therapeutic regimen and their usual clinical-radiological checks according to clinical practice. The control group will consist of 64 healthy subjects, enrolled with prior written informed consent, age and sex-matched with MS patients and selected among the caregivers of the patients. Healthy subjects will only undergo neurophysiological assessment at baseline. The neurophysiological evaluation will include the study of the propagation of potentials induced by stimulation. This method allows the study of cortical responses in terms of time domain and frequency, obtaining a measurement of interhemispheric connectivity and of microstructural and functional integrity of white matter. In the same way, these methods allow the assessment of grey matter integrity through the study of intracortical excitability.
NCT04997343 — Multiple Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT04997343/
Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)
The main purpose of this study is to investigate the effectiveness of cladribine tablets in a UK real-world setting.
NCT04997148 — Relapsing-Remitting Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/relapsing-remitting-multiple-sclerosis/NCT04997148/