[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580205":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":34,"interventions":41,"overallOfficials":27,"centralContacts":47,"locations":53,"responsibleParty":70,"collaborators":27,"id":74,"slug":27,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":27,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":27,"enrollmentInfo":82,"targetDuration":27,"studyType":85,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Campus Bio-Medico University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"NfL reduction","The potential reduction of NfL during treatment is monitored by blood samples collected at baseline, and then , every 3 months during the treatment","12 months",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Monthly Progression Rate (MPR)","MPR is derived from the comparison between the ALSFRS-R (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) decline over the period of at least three months before the treatment, and the period of twelve months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points.","15 months",{"measure":19,"description":20,"timeFrame":12},"New Potential Theranostic Biomarkers Assay","Investigation of potential theranostic biomarkers in blood samples (YKL-40, TDP43) and urine samples (p75ECD), collected at baseline and evrey three months during the treatment",{"measure":22,"description":23,"timeFrame":12},"Effect on resting motor threshold (RMT) and active motor threshold (AMT)","Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.",{"measure":25,"description":26,"timeFrame":12},"Effect on motor evoked potentials (MEP) size","Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"pwALS","EXPERIMENTAL","All participants will undergo tSMS administration at home, in two daily sessions of 120 minutes each.",[40],"Device: Transcranial magnetic stimulation (tSMS)",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":27},"DEVICE","Transcranial magnetic stimulation (tSMS)","Transcranial static magnetic stimulation (tSMS) will be delivered simultaneously to both hemispheres, at the motor cortex (M1), via magnets housed in a helmet.",[36],[48],{"name":49,"role":50,"phone":51,"phoneExt":27,"email":52},"Vincenzo Di Lazzaro","CONTACT","06 22541 1220","v.dilazzaro@policlinicocampus.it",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Fondazione Policlinico Campus Bio-Medico","RECRUITING","Roma","RM","00128","Italy","IT",{"type":63,"coordinates":64},"Point",[65,66],11.10642,44.99364,{"lat":66,"lon":65},[69],{"name":49,"role":50,"phone":51,"phoneExt":27,"email":52},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Di Lazzaro Vincenzo","Full Professor of Neurology","100580205",false,"NCT06834269","Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.","Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).","Inclusion Criteria:\n\n* age ≥ 18\n* diagnosis of possible, probable or definite ALS according to revised El Escorial criteria and Awaji-Shima criteria\n* disease duration \\\u003C 24 months\n* ALSFRS-R \\> 30 at the recruitment\n* ALSFRS-R decline \\> 1 in the at least 3-months period before the intervention\n* normal respiratory functionality at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 \\> 4)\n* treatment with riluzole 50 mg x 2\u002Fdie\n\nExclusion Criteria:\n\n* inclusion in other clinical trials\n* presence of tracheotomy or\u002Fand PEG (percutaneous endoscopic gastrostomy)\n* unable to perform spirometry due to severe bulbar involvement\n* contraindications to magnetic fields exposure\n* pregnancy or breastfeeding\n* history of epilepsy or seizures\n* use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.\n* cognitive impairment\n* lack of informed consent","ALL","18 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[29],"The objective of the present study is to assess the efficacy of tSMS in ALS patients. This will be achieved by monitoring:\n\n* levels of NF-L and other potential innovative biomarkers,\n* clinical progression, trough ALSFRS-R. After at least three-month follow-up, participants will be recruited to undergo biemispheric tSMS for two daily sessions of 120 minutes each, at home, for 12 months. Together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tSMS administration (M0) and during the treatment (M3, M6, M9, M12), to detect potential theranostic biomarkers. In a subgroup of patients, ad additional blood and urine sample will be collected 3 months before M0 (M-3).\n\nMoreover, cortical excitability will be tested through transcranial magnetic stimulation (TMS) before and after the tSMS stimulation period.",[89],"Amyotrophic Lateral Sclerosis (ALS)",[91,92,93,94,95,96,97,98,99,100],"Amyothrophic Lateral Sclerosis","ALS","tSMS","transcranial magnetic stimulation","NF-L","YKL-40","p75ECD","Biomarkers","transcranial static magnetic stimulation","TDP43","2025-02-26",{"date":103,"type":104},"2025-02-28","ACTUAL",{"date":106,"type":104},"2024-12-02",{"date":108,"type":84},"2027-12-31",{"name":5,"class":6},1]