Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=485
{ "count": 4865, "next": "http://api.gregory-ms.com/trials/?format=api&page=486", "previous": "http://api.gregory-ms.com/trials/?format=api&page=484", "results": [ { "trial_id": 27, "title": "MS-NEUROPLAST: Neuroplasticity of Cortical Areas Induced by Cognitive Training in Patients With Multiple Sclerosis", "summary": "Conditions: Multiple Sclerosis; Cognitive DeclineIntervention: Other: Cognitive TrainingSponsors : Aristotle University Of Thessaloniki; King Fahad Medical CityActive, not recruiting ", "published_date": "2021-03-03T00:00:00Z", "discovery_date": "2021-03-19T11:55:20Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04806568", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04806568" }, "categories": [ { "category_id": 18, "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_name": "Physical therapy and Telerehabilitation", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ], "article_count": 179 } ], "export_date": "2024-05-13T00:00:00Z", "internal_number": "13792320", "last_refreshed_on": "2024-03-11", "scientific_title": "Cognitive Decline Prognosis in Multiple Sclerosis: Effectiveness of a Computerized Cognitive Training Treatment on Cortical Reorganization", "primary_sponsor": "Aristotle University Of Thessaloniki", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2020-12-01", "target_size": "180", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).", "phase": "N/A", "countries": "Greece", "contact_firstname": "; ;", "contact_lastname": "Charis Styliadis, PhD;Charis Styliadis, PhD;Charis Styliadis, PhD", "contact_address": null, "contact_email": ";[email protected];[email protected]", "contact_tel": ";6942618582;6942618582", "contact_affiliation": "Aristotle University Of Thessaloniki;", "inclusion_criteria": "<br> Inclusion Criteria for people with MS:\r<br>\r<br> - Male/female patients aged 18 to 55 years at screening\r<br>\r<br> - Diagnosis of MS according to the 2017 Revised McDonald criteria\r<br>\r<br> - Disability status at screening with an EDSS score of 0 to 6.5\r<br>\r<br> - Relapsing MS and progressive MS as defined by Lublin\r<br>\r<br> - Disability status at screening with an EDSS score of 0 to 5.5\r<br>\r<br> - Neurologically stable within 1 month prior to screening\r<br>\r<br> - Years from MS diagnosis: = 10 for relapsing patients\r<br>\r<br> - 15 for progressive patients\r<br>\r<br> - Patients receiving the same Disease Modifying Treatment (DMT) for at least 6 months\r<br>\r<br> Exclusion Criteria for people with MS:\r<br>\r<br> - Patients suspected of not being able or willing to cooperate or comply with study\r<br> protocol requirements\r<br>\r<br> - Patients meeting criteria for other demyelinating diseases of the CNS\r<br>\r<br> - Patients with active chronic disease (or stable but treated with immune therapy) of\r<br> the immune system other than MS\r<br>\r<br> - Patients with any other significant CNS disease or serious psychiatric disorder which\r<br> can interfere with the patient's ability to cooperate or comply with the study\r<br> procedure\r<br>\r<br> - Patients unable or unwilling to undergo MRI scans and EEG\r<br>\r<br> Inclusion Criteria for Healthy Controls:\r<br>\r<br> • Normal hearing and normal or corrected-to-normal vision\r<br>\r<br> Exclusion Criteria for Healthy Controls:\r<br>\r<br> - Any diagnosed neurological, mental, developmental, or psychiatric disorder\r<br>\r<br> - Unrecovered neurological disorders (i.e., stroke, traumatic brain injury)\r<br>\r<br> - Unstable medication within the last 3 months\r<br>\r<br> - Intake of central nervous drugs (e.g., antidepressants)\r<br>\r<br> - Severe physical disorder, and\r<br>\r<br> - Concurrent participation in another relevant study\r<br>\r<br> - Patients unable or unwilling to undergo EEG measurements\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Cognitive Decline", "intervention": "Other: Cognitive Training", "primary_outcome": "Change in current density strength of the cortical activity as measured via EEG;Change in cortical connectivity as measured via EEG;Changes in the graph theory indexes as measured via EEG", "secondary_outcome": "Change in audiovisual integration functionality;Change in Mini Mental Status Examination (MMSE);Change in Clock Drawing Test (CDT);Change in Brief Visuospatial Memory Test (BVMT);Change in Symbol Digit Modalities Test (SDMT);Change in Verbal Fluency: Phonemic [ Chi-Sigma-Alpha];Change in Verbal Fluency: Semantic [Animals-Fruits-Objects];Change in Digit Span (For-Back-Seq) _WAIS-4GR;Change in Stroop Neuropsychological Test (SNST);Change in Greek Accentuation Test (GAT);Change in Depression Anxiety Stress Scale (DASS-21);Change in Multiple Sclerosis Impact Scale (MSIS-29);Change in the Cognitive Reserve Questionnaire (CRIq);Change in Modified Fatigue Impact Scale (MFIS);Change in EQ-5D-5L;Change in EQ-5D-5L -EQ-VAS;Change in Beck Depression Inventory-Fast Screen (BDI-FS);Change in Timed 25-Foot Walk (T25-FW);Change in 3 m backwards walk test;Change in Hole Peg Test (9-HPT);Change in Four Square Step Test (FSST);Change in Single Leg Stance Test (SLS);Change in the Handgrip Strength Test", "secondary_id": "98223", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 25, "title": "Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Other: Theory of MindSponsor : Lille Catholic UniversityNot yet recruiting ", "published_date": "2021-03-16T00:00:00Z", "discovery_date": "2021-03-19T11:55:20Z", "link": "https://clinicaltrials.gov/show/NCT04806217", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04806217" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "11862638", "last_refreshed_on": "2022-01-24", "scientific_title": "Nature of the Link Between Executive Functions and Theory of Mind in Multiple Sclerosis", "primary_sponsor": "Lille Catholic University", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2022-07-01", "target_size": "40", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).", "phase": "N/A", "countries": null, "contact_firstname": ";", "contact_lastname": "Bruno Lenne;Amélie Lansiaux, MD, PhD", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";03.20.22.52.69", "contact_affiliation": "Hôpital Saint-Vincent de Paul - Lille;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> People :\r<br>\r<br> - With multiple sclerosis\r<br>\r<br> - Age = 18 years old\r<br>\r<br> - Not objecting to the use of their data\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any associated neurological pathology or severe or chronic somatic disease (cancer)\r<br>\r<br> - Visual and/or auditory disorders that do not allow for test taking\r<br>\r<br> - Uncontrolled major psychiatric disorders\r<br>\r<br> - Recent treatment with corticosteroids (less than 4 weeks before the evaluation)\r<br>\r<br> - Patients under guardianship, curatorship or safeguard of justice\r<br>\r<br> - Pregnant women\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Theory of Mind", "primary_outcome": "Number of correct answers to the \"unknown reality\" false belief tasks;Number of correct answers to the \"known reality\" false belief tasks", "secondary_outcome": "California Verbal Learning Test (CVLT);Brief Visuo-spatial Memory Test (BVMT);Symbol Digit Modalities Test (SDMT);Stroop test;Trail Making test;Verbal fluency test;Verbal fluency test;Beck Depression Inventory (BDI)", "secondary_id": "RC-P00109", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 26, "title": "Virtual Reality in Physical Therapy in Multiple Sclerosis", "summary": "Condition: Multiple SclerosisInterventions: Device: Neuroproprioceptive "facilitation and inhibition" in virtual reality; Other: Neuroproprioceptive "facilitation and inhibition"Sponsor : Charles University, Czech RepublicNot yet recruiting ", "published_date": "2021-03-16T00:00:00Z", "discovery_date": "2021-03-19T11:55:20Z", "link": "https://clinicaltrials.gov/show/NCT04807738", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04807738" }, "categories": [ { "category_id": 18, "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_name": "Physical therapy and Telerehabilitation", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ], "article_count": 179 } ], "export_date": "2024-05-13T00:00:00Z", "internal_number": "12833077", "last_refreshed_on": "2023-02-20", "scientific_title": "Effect of Neuroproprioceptive \"Facilitation, Inhibition\" Physical Therapy Using Virtual Reality on Upper Limb Mobility and Postural Stability in Multiple Sclerosis", "primary_sponsor": "Charles University, Czech Republic", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "60 Years", "inclusion_gender": "All", "date_enrollement": "2021-04-01", "target_size": "110", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).", "phase": "N/A", "countries": "Czechia", "contact_firstname": ";", "contact_lastname": "Kamila Rasova, as.prof.Dr.;Barbora Miznerova, M.D.", "contact_address": null, "contact_email": ";[email protected]", "contact_tel": ";+420776480210", "contact_affiliation": "Clinic of rheumatology and rehabilitation,Third medical faculty CU and Faculty Thomayer Hospital;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - The inclusion criteria comprise of a definite diagnosis of multiple sclerosis, EDSS\r<br> score = 2 a = 7 ((10); determined by neurologist), no history of relapse, no history\r<br> of change in disease-modifying treatment, no history of corticosteroid therapy in the\r<br> past three months prior to recruitment.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - The exclusion criteria include other factors influencing mobility (history of stroke,\r<br> pregnancy, traumatic injury of limb/s. Severe cardiovascular or orthopedic\r<br> dysfunction, impaired cognitive functions in the course of examination and/or\r<br> consecutive therapy.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Device: Neuroproprioceptive \"facilitation and inhibition\" in virtual reality;Other: Neuroproprioceptive \"facilitation and inhibition\"", "primary_outcome": "Nine Hole Peg Test (9HPT) - change pre/post intervention;Box and Block Test (BNB) - change pre/post intervention;Five times Sit to Stand test (5STS) -change pre/post intervention;Hand Grip Strength (HGS) -change pre/post intervention;Frequency for which the smoothed power spectral density is maximal (fMAX);Power of the signal in band from f1 to f2 (Pf1-f2)", "secondary_outcome": "Multiple Sclerosis Impact Scale (MSIS-29) - change pre/post intervention;EQ-5D-3L-health questionnaire - change pre/post intervention", "secondary_id": "1983/21+4772/21 (G-21-02)", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 24, "title": "Emotions in Multiple Sclerosis", "summary": "Condition: Multiple SclerosisIntervention: Diagnostic Test: Carrying out a tests and questionnaires batterySponsor : Lille Catholic UniversityNot yet recruiting ", "published_date": "2021-03-16T00:00:00Z", "discovery_date": "2021-03-18T11:23:53Z", "link": "https://clinicaltrials.gov/show/NCT04804787", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04804787" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "13154597", "last_refreshed_on": "2023-07-03", "scientific_title": "Emotions Recognition in Multiple Sclerosis", "primary_sponsor": "Lille Catholic University", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2021-06-23", "target_size": "100", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).", "phase": "N/A", "countries": "France", "contact_firstname": "; ;", "contact_lastname": "Bruno Lenne;Amélie Lansiaux, MD, PhD;Bruno Lenne", "contact_address": null, "contact_email": ";[email protected];", "contact_tel": ";03.20.22.52.69;", "contact_affiliation": "Hôpital Saint-Vincent de Paul - Lille;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Male or female between 18 and 55 years old.\r<br>\r<br> - Understand and able to express themselves in French.\r<br>\r<br> - EXPERIMENTAL GROUP :\r<br>\r<br> - Relapsing-remitting form (RRMS)\r<br>\r<br> - With an EDSS < 4 (Expanded Disability Status Scale)\r<br>\r<br> - No significant motor, cerebellar or somatosensory disorders of the upper limbs or\r<br> visual disorders (EDSS specific parameter <2)\r<br>\r<br> - No flare-up in the last 6 weeks\r<br>\r<br> - No corticosteroids taken in the last 4 weeks\r<br>\r<br> - CONTROL GROUP :\r<br>\r<br> - Lack of global cognitive deterioration (according to Brief International Cognitive\r<br> Assessment for Multiple Sclerosis (BICAMS) standards).\r<br>\r<br> - Gender, age and education level matching to the multiple sclerosis patients\r<br>\r<br> - Understanding and signing the informed consent and information letter regarding\r<br> participation in the study.\r<br>\r<br> - Benefiting from health insurance coverage.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Persons with previous neurological pathologies, head trauma with loss of\r<br> consciousness, psychiatric pathologies, serious general affections, perceptive or\r<br> dysarthric disorders preventing verbal communication or reading,\r<br>\r<br> - People with sensory disorders (visual and auditory) that interfere with the\r<br> performance of neuropsychological tests;\r<br>\r<br> - Treatment with psychotropic drugs (except benzodiazepines and hypnotics).\r<br>\r<br> - Refusal to participate after clear and fair information about the study.\r<br>\r<br> - Major persons under guardianship, under judicial protection, persons deprived of\r<br> liberty.\r<br>\r<br> - Pregnant or breastfeeding women\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Diagnostic Test: Carrying out a tests and questionnaires battery", "primary_outcome": "Emotion's valence;Emotion's intensity;Emotion recognition;Certainty's degree of answers", "secondary_outcome": "California Verbal Learning Test (CVLT);Brief Visuo-spatial Memory Test (BVMT);Symbol Digit Modalities Test (SDMT);Stroop test;Trail Making test;Verbal fluency test;Beck Depression Inventory (BDI);State Trait Anxiety Inventory Y-A (STAI Y-A);State Trait Anxiety Inventory Y-B (STAI Y-B);Toronto Alexithymia Scale-20 (TAS-20);Dot Probe Task;Change in the electrodermal response during emotion recognition test", "secondary_id": "RC-P00107", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 22, "title": "Efficacy of COVID-19 Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication", "summary": "Condition: Multiple SclerosisIntervention: Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virusSponsor : Providence Health & ServicesNot yet recruiting ", "published_date": "2021-11-03T00:00:00Z", "discovery_date": "2021-03-15T14:45:21Z", "link": "https://clinicaltrials.gov/show/NCT04796584", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04796584" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "12959260", "last_refreshed_on": "2023-04-10", "scientific_title": "Efficacy of COVID 19 SARS-CoV-2 mRNA Vaccination in Patients With Multiple Sclerosis Treated With Immune Modulating Medication (SARSmRNA_MS)", "primary_sponsor": "Providence Health & Services", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "All", "date_enrollement": "2022-07-11", "target_size": "20", "study_type": "Observational", "study_design": null, "phase": null, "countries": "United States", "contact_firstname": "", "contact_lastname": "Stanley Cohan, MD PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Providence Health & Services", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Able to understand the purpose, benefits, and risks of the study; willing and able to\r<br> adhere to the study requirements; able to provide informed consent in English\r<br>\r<br> 2. Male or female, between the ages of 18 and 65 years inclusive at time of consent\r<br>\r<br> 3. Meet one of the following:\r<br>\r<br> 1. Plan to receive one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations\r<br> within 30 days of the screening visit\r<br>\r<br> 2. Have received one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations,\r<br> their first vaccine injection having occurred 45±7 days prior to the screening\r<br> visit\r<br>\r<br> 3. Have received one of the FDA approved mRNA-based COVID SARS-CoV-2 vaccinations,\r<br> their first vaccine injection having occurred 90±7 days prior to the screening\r<br> visit\r<br>\r<br> 4. Meet the criteria of one of the four groups at the time of consent:\r<br>\r<br> Group 1: Diagnosed with multiple sclerosis and currently being treated with a stable dose\r<br> of ocrelizumab, for 6 months or longer Group 2: Diagnosed with multiple sclerosis and\r<br> currently being treated with a stable dose of fingolimod, for 6 months or longer Group 3:\r<br> Diagnosed with multiple sclerosis and currently being treated with a stable dose of\r<br> natalizumab, for 6 months or longer Group 4: Diagnosed with multiple sclerosis and\r<br> currently being treated with a stable dose of dimethyl fumarate or diroximel fumarate, for\r<br> 6 months or longer\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Subjects who have a BMI of >35.0 will be excluded\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus", "primary_outcome": "Titer of antibody against SARS-CoV-2 spike protein;Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein;Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein", "secondary_outcome": "Titer of antibody against SARS-CoV-2 spike protein;Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein;Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein;Titer of antibody against SARS-CoV-2 spike protein;Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein;Titer of antibody against SARS-CoV-2 spike protein;Quantity of TNF-a secreted in response to stimulation with SARS-CoV-2 spike protein;Quantity of IFN-g secreted in response to stimulation with SARS-CoV-2 spike protein", "secondary_id": "SARSmRNA_MS", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 23, "title": "Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis", "summary": "Conditions: Multiple Sclerosis; Clinically Isolated SyndromeInterventions: Biological: blood sample; Biological: cerebro-spinal fluidSponsors : University Hospital, Bordeaux; University of BordeauxNot yet recruiting ", "published_date": "2021-11-03T00:00:00Z", "discovery_date": "2021-03-15T14:45:21Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04798651", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04798651" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "13666192", "last_refreshed_on": "2024-01-29", "scientific_title": "Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis", "primary_sponsor": "University Hospital, Bordeaux", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2021-09-30", "target_size": "150", "study_type": "Interventional", "study_design": "Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).", "phase": "N/A", "countries": "France", "contact_firstname": "; ; ;", "contact_lastname": "Aurélie RUET, Prof;Nathalie SCHMITT, PhD;Aurélie RUET, Prof;Aurélie RUET, Prof", "contact_address": null, "contact_email": ";;[email protected];[email protected]", "contact_tel": ";;05 56 79 55 21;", "contact_affiliation": "CHU Bordeaux;University of Bordeaux;", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - male or female subjects ;\r<br>\r<br> - Age = 18 years;\r<br>\r<br> - subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical\r<br> isolated syndrome;\r<br>\r<br> - patients for which a blood draw and / or lumbar puncture to collect CSF is performed\r<br> for diagnostic or therapeutic purpose;\r<br>\r<br> - affiliated to an health insurance system;\r<br>\r<br> - and who agree to participate in the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Pregnant or breastfeeding women,\r<br>\r<br> - patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty\r<br> by a judicial or administrative decision, minors, persons of legal age who are the\r<br> object of a legal protection measure or unable to express their consent)\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Clinically Isolated Syndrome", "intervention": "Biological: blood sample;Biological: cerebro-spinal fluid", "primary_outcome": "Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.", "secondary_outcome": "Quantification of disease activity scores;Quantification of disease activity scores;Number of lesions;Size of lesions;Localisation of lesions;Types of lesions;duration of the disease;age at onset and progression;number of relapses;date of relapses;Treatment", "secondary_id": "CHUBX 2020/71", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 21, "title": "Role of Individualized Versus Traditional Exercise in Combating Fatigue", "summary": "Condition: Multiple SclerosisInterventions: Other: Adapted and individualized physical training program; Other: traditional training programSponsor : Centre Hospitalier Universitaire de Saint EtienneNot yet recruiting ", "published_date": "2021-01-15T00:00:00Z", "discovery_date": "2021-03-12T14:58:20Z", "link": "https://clinicaltrials.gov/ct2/show/NCT04796272", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04796272" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "13524256", "last_refreshed_on": "2023-11-13", "scientific_title": "Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients", "primary_sponsor": "Centre Hospitalier Universitaire de Saint Etienne", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "All", "date_enrollement": "2021-04-02", "target_size": "30", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Participant).", "phase": "N/A", "countries": "France", "contact_firstname": "", "contact_lastname": "Jean Philippe CAMDESSANCHE, MD PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "CHU SAINT-ETIENNE", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Aged 18 to 70 years old\r<br>\r<br> - Male or female\r<br>\r<br> - With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010\r<br> criteria.\r<br>\r<br> - Between 2 and 25 years from the onset of multiple sclerosis\r<br>\r<br> - With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4\r<br> and Fatigue questionnaire > 38.\r<br>\r<br> - Expanded Disability Status Scale Score 5\r<br>\r<br> - Testing = 4 in all leg muscles.\r<br>\r<br> - Ability to walk for 10 minutes without stopping (self-reported)\r<br>\r<br> - Affiliates or beneficiaries of a social security scheme\r<br>\r<br> - Having freely given their written consent after having been informed of the purpose,\r<br> course of action and potential risks involved\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Severe cerebellar spasticity or ataxia in either leg.\r<br>\r<br> - Abnormal range of motion of the toes and/or ankle.\r<br>\r<br> - Musculoskeletal injury that interferes with pedaling.\r<br>\r<br> - High resting heart rate (>90 beats per minute).\r<br>\r<br> - Blood pressure > 144/94 mmHg.\r<br>\r<br> - Onset of a multiple sclerosis attack within 90 days prior to the study.\r<br>\r<br> - Recent adjustment of any medication or drugs that may impact on fatigue, or taking\r<br> stimulants for fatigue (e.g. Modafinil).\r<br>\r<br> - Taking of neuro-active substances that may impair cortico-spinal excitability\r<br> (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) throughout the study\r<br> period.\r<br>\r<br> - Contraindication to the application of a magnetic field\r<br>\r<br> - History of co-morbid disease or conditions that would compromise the subject's safety\r<br> during the study.\r<br>\r<br> - Participation at the same time in another medical intervention study or having\r<br> participated in such a study within 30 days prior to this study.\r<br>\r<br> - Pregnant and Nursing Women\r<br>\r<br> - Women of childbearing age without effective contraception\r<br>\r<br> - Patient unable to understand the purpose and conditions of the study, incapable of\r<br> giving consent\r<br>\r<br> - Patient deprived of liberty or patient under guardianship\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Adapted and individualized physical training program;Other: traditional training program", "primary_outcome": "Chronic fatigue score", "secondary_outcome": "cardiorespiratory fitness;Hematological parameters;Inflammatory parameters;quality of sleep;cortical activation level;cortico-spinal excitability;neuromuscular fatigue of peripheral function;Analysis overall quality of life : Fatigue questionnaire;Analysis overall quality of life :Quality of Life;Analysis overall quality of life :Depression;Analysis overall quality of life : Sleep Quality;Analysis overall quality of life : Physical Activity", "secondary_id": "2020-A00841-38;20CH032", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 19, "title": "3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis (FLACON)", "summary": "Conditions: Optic Neuritis; Multiple Sclerosis; EncephalopathyIntervention: Diagnostic Test: Magnetic Resonance ImagingSponsor : Fondation Ophtalmologique Adolphe de RothschildCompleted ", "published_date": "2021-08-03T00:00:00Z", "discovery_date": "2021-03-11T12:25:31Z", "link": "https://clinicaltrials.gov/show/NCT04792866", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04792866" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "10749115", "last_refreshed_on": "2021-03-22", "scientific_title": "3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination", "primary_sponsor": "Fondation Ophtalmologique Adolphe de Rothschild", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2018-01-01", "target_size": "1200", "study_type": "Observational", "study_design": null, "phase": null, "countries": "France", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age > 18 years\r<br>\r<br> - Decrease in visual acuity explored in MRI between january 2018 and january 2020\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Past history of episode of Optic neuritis\r<br>", "exclusion_criteria": null, "condition": "Optic Neuritis;Multiple Sclerosis;Encephalopathy", "intervention": "Diagnostic Test: Magnetic Resonance Imaging", "primary_outcome": "Detection of optic neuropathies using MRI", "secondary_outcome": null, "secondary_id": "CE_20200204_1_ALR", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 20, "title": "Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis (COCON)", "summary": "Conditions: Optic Neuritis; Multiple SclerosisIntervention: Diagnostic Test: Magnetic Resonance ImagingSponsor : Fondation Ophtalmologique Adolphe de RothschildCompleted ", "published_date": "2021-08-03T00:00:00Z", "discovery_date": "2021-03-11T12:25:31Z", "link": "https://clinicaltrials.gov/show/NCT04793087", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04793087" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "10749130", "last_refreshed_on": "2021-03-22", "scientific_title": "Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination", "primary_sponsor": "Fondation Ophtalmologique Adolphe de Rothschild", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2018-01-01", "target_size": "1200", "study_type": "Observational", "study_design": null, "phase": null, "countries": "France", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Age > 18 years\r<br>\r<br> - Decrease in visual acuity explored in MRI between january 2018 and january 2020\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Past history of episode of Optic neuritis\r<br>", "exclusion_criteria": null, "condition": "Optic Neuritis;Multiple Sclerosis", "intervention": "Diagnostic Test: Magnetic Resonance Imaging", "primary_outcome": "Detection of optic neuropathies using MRI", "secondary_outcome": null, "secondary_id": "CE_20200204_2_ALR", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 18, "title": "Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)", "summary": "Condition: Secondary Progressive Multiple SclerosisInterventions: Drug: BAF312; Drug: Baseline disease modifying therapies (DMTs)Sponsor : Novartis PharmaceuticalsNot yet recruiting ", "published_date": "2021-08-03T00:00:00Z", "discovery_date": "2021-03-11T12:25:30Z", "link": "https://clinicaltrials.gov/show/NCT04792567", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT04792567" }, "categories": [], "export_date": "2024-05-13T00:00:00Z", "internal_number": "12728904", "last_refreshed_on": "2023-01-09", "scientific_title": "An Open-label Multicenter Study to Assess Response to SARS-CoV-2 modRNA Vaccines in Participants With Secondary Progressive Multiple Sclerosis Treated With Mayzent (Siponimod)", "primary_sponsor": "Novartis Pharmaceuticals", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "100 Years", "inclusion_gender": "All", "date_enrollement": "2021-04-19", "target_size": "41", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 4", "countries": "Germany", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Secondary Progressive Multiple Sclerosis (SPMS) diagnosis or with Relapsing Remitting\r<br> Multiple Sclerosis (RRMS) at risk to develop SPMS (at the discretion of the treating\r<br> physician)\r<br>\r<br> - on stable MS treatment (Siponimod, dimethylfumarate, glatirameracetate, interferon,\r<br> teriflunomode or no current treatment)\r<br>\r<br> - no recent treatment changes\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - prior or current COVID-19 disease\r<br>\r<br> - SARS-CoV-2 antibodies at screening Other protocol-defined inclusion/exclusion criteria\r<br> may apply\r<br>", "exclusion_criteria": null, "condition": "Secondary Progressive Multiple Sclerosis", "intervention": "Drug: BAF312;Drug: Baseline disease modifying therapies (DMTs)", "primary_outcome": "Percentage of participants achieving seroconversion after receiving a modRNA vaccine", "secondary_outcome": "SARS-CoV-2 serum functional antibody levels over time;T-cell response to modRNA vaccines over time;Number of treatment emergent adverse events, serious adverse events and COVID-19 infections", "secondary_id": "2020-005752-38;CBAF312ADE03", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null } ] }