[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568467":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":35,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Parc de Salut Mar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TPS","EXPERIMENTAL","The stimulation will be 20 min duration as indicated in the CE mark approval. Each session involves 6,000 pulses in the hand region of the motor cortex with 3,000 on each side of the brain. The system uses a low energy flux density maximum of 0.25 mJ\u002Fmm2 accordingly with EMA and FDA guidelines (high energy is defined as \\> 0.5 mJ\u002Fmm2). The standard therapy involves 6 sessions in 2 weeks as indicated in the CE mark.",[13],"Device: Transcranial Pulse Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"sham","SHAM_COMPARATOR","The transcranial pulse stimulation with the same device and the same protocol uses a membrane on the device that blocks the sound waves. Participants' motor cortex is not stimulated.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Transcranial Pulse Stimulation","low intensity shock-waves stimulation of the motor cortex, bilateral",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Alba Leon, MD","CONTACT","+34932 48 30 00","aleonjorba@psmar.cat",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hospital del Mar","RECRUITING","Barcelona","Catalonia","08003","Spain","ES",{"type":42,"coordinates":43},"Point",[44,45],2.15899,41.38879,{"lat":45,"lon":44},[48,51],{"name":49,"role":29,"phone":30,"phoneExt":25,"email":50},"Sergio Vidal, MD","sergio.vidal.notari@psmar.cat",{"name":28,"role":52,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100568467","testing-pulse-stimulation-to-improve-motor-function-in-people-with-als-a-pilot-study-100568467",false,"NCT06681610","Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study","Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial","TPS4ALS","Inclusion Criteria:\n\n* Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria\n* SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential\n* 21 to 80 years old and male or female\n\nExclusion Criteria:\n\n* patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below","ALL","21 Years","80 Years",{"count":67,"type":68},50,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are:\n\n* Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8?\n* Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score?\n\nIn stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score\n\nParticipants will receive either:\n\n* the TPS treatment\n* a sham TPS treatment",[74],"Amyotrophic Lateral Sclerosis (ALS)",[76,74],"Transcranial Pulse Stimulation (TPS)","2024-11-07",{"date":79,"type":80},"2024-11-08","ACTUAL",{"date":82,"type":80},"2024-10-24",{"date":84,"type":68},"2026-12",{"name":5,"class":6},1]