[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560760":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":30,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":30,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":30,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":83,"whyStopped":30,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":30},{"fullName":5,"class":6},"Sierra Varona SL","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Combination of transcranial magnetic stimulation and percutaneous tibial nerve stimulation.",[13],"Device: Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2","Repetitive Transcranial Magnetic Stimulation (rTMS):",[18],"Device: Repetitive Transcranial Magnetic Stimulation",{"label":20,"type":10,"description":21,"interventionNames":22},"Group 3","Percutaneous tibial nerve stimulation.",[23],"Device: Percutaneous Tibial Nerve Stimulation",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Repetitive Transcranial Magnetic Stimulation and Percutaneous Tibial Nerve Stimulation","Repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure that uses a magnetic coil placed on the scalp to deliver magnetic pulses to the motor cortex, with the aim of improving bladder function by modulating brain activity associated with bladder control. The MagRex magnetic stimulator with an 8-shaped coil will be used at a frequency of 10 Hz, delivering 2000 pulses per session (6 seconds on, 24 seconds rest protocol) at 90% of the motor threshold. The treatment will consist of 3 sessions per week over a period of 4 weeks.\n\nPercutaneous Tibial Nerve Stimulation (PTNM): PTNM involves the use of electrical stimulation applied to the posterior tibial nerve to enhance bladder function by modulating neural pathways. A needle will be placed 5-6 cm proximal to the tibial malleolus, with the following parameters: 200 μs pulse duration, 20 Hz frequency, 30 minutes per session, 3 times per week for 12 weeks. The Neurotrac Pelvitone device will be used.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Repetitive Transcranial Magnetic Stimulation","Repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure that uses a magnetic coil placed on the scalp to deliver magnetic pulses to the motor cortex, with the aim of improving bladder function by modulating brain activity associated with bladder control. The MagRex magnetic stimulator with an 8-shaped coil will be used at a frequency of 10 Hz, delivering 2000 pulses per session (6 seconds on, 24 seconds rest protocol) at 90% of the motor threshold. The treatment will consist of 3 sessions per week over a period of 4 weeks.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Percutaneous Tibial Nerve Stimulation","Percutaneous Tibial Nerve Stimulation (PTNM): PTNM involves the use of electrical stimulation applied to the posterior tibial nerve to enhance bladder function by modulating neural pathways. A needle will be placed 5-6 cm proximal to the tibial malleolus, with the following parameters: 200 μs pulse duration, 20 Hz frequency, 30 minutes per session, 3 times per week for 12 weeks. The Neurotrac Pelvitone device will be used.",[20],[40],{"name":41,"affiliation":42,"role":43},"Elena Fernández, Physiotherapist","Fundación de Investigación Biomédica - Hospital Universitario de La Princesa","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"ALBERTO SANCHEZ SIERRA, PhD","CONTACT","+34608801238","alberto.sanchez@uclm.es",{"name":51,"role":47,"phone":52,"phoneExt":30,"email":53},"Arturo Ladriñán Maestro, Msc","+34926295377","arturo.ladrinan@uclm.es",{"type":55,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[57],{"name":58,"class":6},"Universidad Complutense de Madrid","100560760","enhancing-pelvic-floor-function-with-transcranial-magnetic-and-tibial-nerve-stimulation-for-neurogenic-bladder-in-ms-100560760",false,"NCT06581341","Enhancing Pelvic Floor Function With Transcranial Magnetic and Tibial Nerve Stimulation for Neurogenic Bladder in MS","Improvement of Pelvic Floor Function Using Repetitive Transcranial Magnetic Stimulation and Posterior Tibial Nerve Stimulation in Treating Neurogenic Overactive Bladder in Patients With Multiple Sclerosis","Inclusion Criteria:\n\n* Volunteer Adults (Age 18-65)\n* Diagnosis of Multiple Sclerosis\n* Expanded Disability Status Scale (EDSS) 0-7\n* Diagnosis of overactive bladder disfunction secondary to multiple sclerosis\n\nExclusion Criteria:\n\n* Active urinary tract infection at the time of selection.\n* Individuals with a history of urological conditions other than overactive bladder secondary to multiple sclerosis.\n* Contraindications for electrical stimulation:\n* Presence of metal in the skull\n* Intracardiac lines\n* History of increased intracranial pressure\n* Significant heart disease\n* Pacemaker or implantable desfibrillator usage\n* Use of implanted medication pumps\n* Treatment with tricyclic antidepressants or neuroleptics\n* Personal or family history of epilepsy\n* Pregnant or breastfeeding women","ALL","18 Years","65 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"NA","Multiple Sclerosis (MS) is a chronic, autoimmune, inflammatory, and degenerative neurological disorder that affects the central nervous system. Symptoms vary widely depending on the areas impacted and may include fatigue, vision issues, speech difficulties, tremors, limb weakness, loss of sensation, vertigo, coordination problems, and bladder and bowel dysfunction. Among these, lower urinary tract symptoms are particularly common and significantly impact the quality of life for MS patients.\n\nNeurogenic overactive bladder (NOAB) is a prevalent urinary issue in individuals with MS. Treatment options for NOAB include behavioral therapy, β-3 agonists, anticholinergic agents, posterior tibial nerve neuromodulation (PTNM), botulinum toxin injections, sacral root neurostimulation, and surgical interventions.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that may improve bladder function by modulating neural activity through an electromagnetic coil placed on the scalp. In contrast, posterior tibial nerve neuromodulation (PTNM) involves electrical stimulation of the spinal cord roots, primarily the S3 segment, to enhance bladder function.\n\nDespite promising evidence, rTMS and PTNM are not yet widely recommended in global guidelines due to the limited number of studies, many of which are case reports. The growing prevalence of overactive bladder underscores the need for effective, non-invasive treatments to improve management and optimize current protocols.\n\nThis study aims to evaluate and compare the efficacy of rTMS and tibial nerve stimulation in managing neurogenic overactive bladder in MS patients at Hospital Universitario de la Princesa. The primary objective is to determine whether rTMS is superior, equivalent, or inferior to tibial nerve stimulation in treating NOAB.\n\nThe study's hypothesis is that the efficacy of transcranial magnetic stimulation will differ from that of tibial nerve stimulation in managing NOAB in MS patients at Hospital Universitario de la Princesa, with a focus on assessing whether rTMS offers superior, equivalent, or inferior outcomes compared to tibial nerve stimulation. This investigation seeks to provide valuable insights into the effectiveness of these treatment modalities.",[77,78],"Neurogenic Overactive Bladder","Multiple Sclerosis",[80,77,81,82],"Múltiple Sclerosis","Posterior Tibial Nerve Meuromodulation","Repetitive Transcranial Magnetic Stimulation.","NOT_YET_RECRUITING","2024-08-27",{"date":86,"type":87},"2024-09-03","ACTUAL",{"date":89,"type":71},"2024-10-01",{"date":91,"type":71},"2025-09-22",{"name":5,"class":6}]