[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635052":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":32,"collaborators":34,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":22,"eligibilityCriteria":47,"healthyVolunteers":44,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":25},{"fullName":5,"class":6},"Universidad de Murcia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group tDCS","EXPERIMENTAL","Children aged 4 to 14 with amblyopia treated at one of the collaborating hospitals and centers, with visual acuity in the amblyopic eye between 20\u002F32 and 20\u002F200. They will undergo tests of visual acuity, stereoscopic visual acuity, fixation, and contrast sensitivity. The direct current will be gradually increased over 34 seconds to 2 mA, held constant for 15 minutes, and then gradually reduced to zero using NIC2® v2.1.2.0 software (Neuroelectrics®, Barcelona, Spain). The stimulating current is applied using two rubber electrodes housed in circular sponge pockets (8 cm² each) soaked in saline solution. The electrodes are placed at Oz (active\u002Fstimulating electrode, located in the visual cortex) and Cz (reference electrode).",[13],"Device: tDCS",{"label":15,"type":16,"description":17,"interventionNames":18},"Group Sham","SHAM_COMPARATOR","The sham group is equipped with the same electrostimulation helmet, but the intensity protocol is set to 0 at all times. The same measurements are taken and exactly the same procedure is followed as with the experimental group.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","tDCS","The direct current is gradually increased over 34 seconds until it reaches 2 mA, remains constant for 15 minutes, and then is gradually reduced to zero using NIC2® v2.1.2.0 software (Neuroelectrics®, Barcelona, Spain). The stimulating current is applied using two rubber electrodes housed in circular sponge pockets (8 cm² each) soaked in saline solution. The electrodes are placed at Oz (active\u002Fstimulating electrode, located in the visual cortex) and Cz (reference electrode). This includes a total of 3 sessions of 15 minutes and 34 seconds separated by 48 hours.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Dr. Francisco Javier Valiente Soriano, Optics and Optometry","CONTACT","+34 670 25 58 48","fjvaliente@um.es",{"type":33,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[35,37,40],{"name":36,"class":6},"Hospital Universitario Virgen de la Arrixaca",{"name":38,"class":39},"Hospital Universitario Reina Sofia de Cordoba","OTHER_GOV",{"name":41,"class":6},"Hospital General Universitario Morales Meseguer","100635052","effectiveness-of-tdcs-in-paediatric-amblyopia-100635052",false,"NCT07547670","Effectiveness of tDCS in Paediatric Amblyopia.","Inclusion Criteria:\n\n* Children aged 4-14 years.\n* Strabismic amblyopia resistant to patching (PEDIG criteria).\n* Anisometropic amblyopia resistant to patching (PEDIG criteria).\n\nExclusion Criteria:\n\n* Ocular pathology.\n* Nystagmus.\n* Mental disability.\n* Cognitive delay.\n* Neurological problems incompatible with treatment.\n* Pacemakers.\n* Intracranial electrodes.\n* Implanted defibrillators.\n* Cranial pathologies.\n* Cranial lesions.\n* Withdrawal will occur upon adverse events, protocol deviation, refusal, or loss to follow-up.","ALL","4 Years","14 Years",{"count":52,"type":53},100,"ESTIMATED","INTERVENTIONAL",[56],"NA","The goal of this randomized, double-blind clinical trial is to determine whether transcranial direct current stimulation (tDCS) can effectively and safely improve vision in children aged 4-14 years with strabismic or anisometropic amblyopia that has not responded to conventional patching therapy.\n\nThe main questions it aims to answer are:\n\nDoes tDCS produce significant and sustained improvements in visual acuity, contrast sensitivity, and stereopsis in children with amblyopia?\n\nIs tDCS a safe, well-tolerated, and faster alternative or complementary treatment compared with standard occlusion therapy?\n\nDoes tDCS induce functional and structural changes in the visual cortex associated with increased neuroplasticity, including modulation of GABAergic activity?\n\nIf there is a comparison group:\n\nResearchers will compare active tDCS with sham (placebo) stimulation to see if active treatment leads to greater visual recovery and cortical changes than placebo.\n\nParticipants will:\n\nReceive several sessions of active or sham tDCS using low-intensity electrical stimulation applied to visual brain areas.\n\nUndergo standard visual assessments, including visual acuity, contrast sensitivity, and stereopsis.\n\nComplete neurophysiological and neuroimaging evaluations (EEG, pattern visual evoked potentials, and functional MRI).\n\nProvide biochemical measures related to GABA levels.\n\nThis study aims to validate tDCS as a non-invasive, child-friendly, and effective therapy that may overcome the limitations of patching and support its inclusion in paediatric clinical practice.",[59,60,61,62],"Amblyopia","Amblyopia Strabismic","Visual Acuity","Stereoscopic Vision",[22,64],"Ambyopia","NOT_YET_RECRUITING","2026-04-23",{"date":68,"type":69},"2026-04-29","ACTUAL",{"date":71,"type":53},"2026-06-01",{"date":73,"type":53},"2029-08-31",{"name":5,"class":6}]