[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ad scientiam\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,67,91,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100617799","holistic-assessment-and-remote-digital-monitoring-of-myasthenia-gravis-via-myosense-360-100617799",false,"NCT07323316","Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360","HARMONY 360","Inclusion Criteria:\n\n* Age ≥ 18 years at screening\n* Patients with gMG diagnosis confirmed by the investigator based at least on one of the following:\n* Positive antibody testing for ACHR or MuSK antibodies; or,\n\n  * LRP-4 antibodies or seronegative patients with additional positive single fiber examination; or,\n  * Abnormal single-fiber EMG (SFEMG) jitter in at least one clinically weak muscle; or,\n  * Objective evidence of improvement of clinical gMG symptoms following treatment with oral AChEI or positive pyridostigmine or neostigmine or edrophonium test\n* MGFA Class IIa to IVb\n* Having read the information sheet and signed the informed consent form\n* Owning and able to use a personal smartphone which software version is above 16 for iOS and 8 for Android included\n* Able to read languages in which the mobile application is available and able to understand pictograms (MyoSense 360 is available in local official languages)\n* Able to use an activity monitor (per Actigraph LEAP activity monitor wearability criteria; see vendor guidance)\n* For France only, affiliated with or benefiting from a social security system\n\nExclusion Criteria:\n\n* Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.\n* Person under guardianship or curatorship\n* Current drugs or\u002Fand alcohol abuse that could influence performance on the tests, as judged by the investigator\n* Participant has participated in another interventional clinical study within 30 days prior to screening or who are currently enrolled in another study that, in the - Investigator's opinion, could interfere with their full participation in this study or confound the assessment of the subject or study outcomes\n* For France only, participant who has received more than €6,000 in compensation over the past 12 months for participating in human research, clinical trials, clinical investigations or performance studies.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of the HARMONY 360 investigation is to explore the feasibility of using MyoSense 360 digital measures to develop models capable of detecting clinically meaningful changes in generalized Myasthenia Gravis (gMG) trajectory over 12 months under real-world conditions. Its main objective is not yet to demonstrate the final conformity of the device (exploratory study under article 82), but to collect preliminary data of safety and clinical performance that will help to refine the final product and inform the subsequent pivotal study.\n\nThe primary objective focuses on developing models to detect disease trajectory changes defined by the clinically significant +\u002F- 2 points MG-ADL threshold. Secondary objectives include assessing usability, adherence, and the feasibility of models for worsening\u002Fexacerbation prediction. Finally, risks and anticipated Adverse Device Effects (ADEs) associated with the device use will be monitored continuously throughout the investigation. Consistent with its Proof of Concept stage, the study defines no claims of clinical performance, effectiveness or safety.",[26],"Myasthenia Gravis, Generalized","NOT_YET_RECRUITING","2025-12-29",{"date":30,"type":31},"2026-01-07","ACTUAL",{"date":33,"type":20},"2026-04",{"date":35,"type":20},"2027-10",{"name":37,"class":38},"Ad scientiam","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100545763","chronic-fatigue-in-multiple-sclerosis-ms-copilot-boost-solution-compared-to-standard-care-100545763","NCT06386133","Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care","Chronic Fatigue in Multiple Sclerosis: Validating Clinical Performance, Economic, and Organizational Benefits of MSCopilot Boost Compared to Standard Care","MSBoost","Inclusion Criteria:\n\n* Aged over 18 years\n* With a confirmed MS diagnosis according to 2017 McDonald's revised criteria\n* Having an EDSS score comprised between 0 and 6.5\n* With a fatigue score ≥ 43 on MFIS scale\n* Able to walk with or with walking aids\n* Owning a personal smartphone with a mobile operating system version higher than 14 for IOS (iPhone) and 8 for Android\n* Able to read the language in which the mobile application is available and able to understand pictograms\n* Affiliated to a social security system\n* Having signed the free and informed consent\n* Having accepted to wear an actimeter during the whole duration of study participation\n* Having been on a stable disease-modifying therapy for MS for at least 6 months.\n\nExclusion Criteria:\n\n* Psychiatric disorder, major visual or cognitive deficiency, as assessed by the investigator\n* Participation in an exercise reconditioning program at a rehabilitation center within the 6 weeks prior to inclusion\n* Major comorbidities that could influence fatigue management (lupus, rheumatoid arthritis, chronic obstructive pulmonary disease, chronic fatigue syndrome, etc).\n* Contraindication to physical activity:\n* History of cardiac events:\n* Abnormal cardiac examination at last medical check-up.\n* Palpitations, tachycardia or irregular heartbeat\n* Pain and shortness of breath:\n* Cramp-like pain in the lower limbs when walking, disappearing when walking stops, except for MS-related pain (neuropathic or spastic).\n* Chest pain\n* Shortness of breath at rest (appearing or worsening in the lying position)\n* Shortness of breath during low-intensity exercise or usual activities\n* Pain, discomfort or heaviness in the chest at rest or during exertion\n* Unstable chronic diseases :\n* Unstable metabolic disease\n* Unstable renal disease\n* Uncontrolled chronic disease\n* Ankle edema\n* Dizziness or syncope\n* Having received fampridine, corticosteroid therapy or therapeutic cannabis within the 2 months prior to inclusion.\n* Psychoactive substances and\u002For alcohol consumption likely to influence test performance (investigator's judgment).\n* Patients confined to bed or whose daily activity is less than 2 hours.\n* Persons under guardianship or curatorship.\n* Pregnant or breast-feeding women.\n* Subjects who have participated in another clinical study within 30 days prior to selection, or who are participating in another study that, in the opinion of the investigator, could interfere with full participation in the study or confound the participant's assessment or the study results.",{"count":48,"type":20},208,[23],"The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS).\n\nThe secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution.\n\nPatients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program.\n\nHealthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a \"big picture\" of the patient's condition over time.",[52,53],"Multiple Sclerosis","Fatigue Syndrome, Chronic",[55,56,57,58],"Mobile application","Digital monitoring","Fatigue management","Multiple sclerosis","2025-09-30",{"date":61,"type":31},"2025-10-03",{"date":63,"type":20},"2026-12-01",{"date":65,"type":20},"2027-08-01",{"name":37,"class":38},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100482661","the-memg-digital-solution-for-autonomous-assessment-of-myasthenia-gravis-100482661","NCT05564936","The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis","The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study","Inclusion Criteria:\n\n* Aged over 18 Years\n* Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator\n* With positive serologic testing for anti-AChR autoantibody at screening\n* Have read the information sheet and signed the informed consent form\n* Own a personal smartphone which software version is above 13 for IOS and 8 for Android included\n* Able to use a smartphone\n* Able to read language in which the mobile application is available (French, English, Spanish) and able to understand pictograms\n\nExclusion Criteria:\n\n* Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of screening\n* Subjects having initiated FcRn inhibitor therapy within the four weeks preceding screening\n* Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.\n* Pregnant and nursing women\n* Person under guardianship or curatorship\n* Current drugs or\u002Fand alcohol abuse that could influence performance on the tests, as judged by the investigator\n* Participant included in another ME\\&MG clinical study\n* Participant has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the subject's full participation in the study or confound the assessment of the subject or outcome of the study.",true,{"count":76,"type":20},144,[23],"ME\\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.\n\nME\\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.\n\nThe objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.",[80],"Myasthenia Gravis","RECRUITING","2025-04-08",{"date":84,"type":31},"2025-04-11",{"date":86,"type":31},"2024-01-24",{"date":88,"type":20},"2026-09-24",{"name":37,"class":38},19,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100482802","performance-and-safety-of-a-digital-tool-for-unsupervised-self-assessment-of-nmosd-100482802","NCT05566769","Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD","Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder","OPTIS","Inclusion Criteria:\n\n* Aged over 18 years old\n* NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)\n* With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)\n* EDSS =\\\u003C 7\n* With no evidence of relapse in the past 3 months before enrollment\n* Who have read the information sheet and signed the informed consent form\n* Able to use a smartphone\n* Owns a personal smartphone which version is above 13 for IOS and 8 for Android included\n* Able to read language in which the mobile application is available and able to understand pictograms\n\nExclusion Criteria:\n\n* Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning\n* Pregnant and nursing women\n* Person under guardianship or curatorship\n* Bedridden patients or patients with a daily activity of less than 2 hours per day\n* Current drugs or\u002Fand alcohol abuse that could influence performance on the tests (clinician's judgment)\n* Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.",{"count":100,"type":20},103,[23],"NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms.\n\nThe objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.",[104],"Neuromyelitis Optica",[106,107,108,109],"NMO","NMOSD","Neuromyelitis optica","Neuromyelitis optica spectrum disorder",{"date":111,"type":31},"2025-04-10",{"date":113,"type":31},"2023-11-03",{"date":115,"type":20},"2026-09",{"name":37,"class":38},22,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100526231","a-usability-validation-of-the-mucopilot-mobile-application-a-digital-tool-for-the-unsupervised-objective-assessment-of-cystic-fibrosis-100526231","NCT06132048","A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis","MuControl-Sum","Inclusion Criteria:\n\n* Aged ⩾ 18 years old\n* Patients diagnosed with cystic fibrosis\n* Enrolled in or benefiting of a Social Security program\n* Having read the information sheet and signed the informed consent form\n* Owning a personal smartphone which version is above 14 for IOS and 8 for Android included with a good internet connexion\n* Able to read French and understand pictograms on a smartphone app\n\nExclusion Criteria:\n\n* History of lung transplantation\n* Pregnant women and women who are breastfeeding\n* Any medical condition that could interfere with the proper conduct and results of the study (clinician's judgement)\n* Illiterate in French\n* Inability to use a smartphone or MuCopilot application\n* Person under legal protection (including guardianship or curatorship)",{"count":126,"type":20},17,[23],"The study aims to assess the usability and safety of use of MuCopilot, a smartphone application that measures objective data on lung function, global exercise capacity and patient reported outcomes of patients with Cystic Fibrosis (CF). These data are collected during unsupervised digital tests performed in the patient's home environment between consultations.\n\nThe primary objective is to validate the usability and safety of use, in order to assure that the patients use the medical device as intended without any unacceptable error of use and without unacceptable risk.\n\nThe study will include 17 CF patients and will be conducted in France. They will participate in 1 inclusion visit and 1 visit in-clinic (1h30).\n\nPatients will be able to download the free MuCopilot mobile application. During the visit, patients will complete 3 digital tests in order to monitor CF functions (cough, dyspnea \\& walking) and 1 symptom questionnaire.",[130],"Cystic Fibrosis","2025-01-27",{"date":133,"type":31},"2025-01-29",{"date":135,"type":31},"2024-07-01",{"date":137,"type":20},"2025-02",{"name":37,"class":38},1,""]