[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650865":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":46,"responsibleParty":100,"collaborators":102,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":27,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":49,"whyStopped":27,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Polytechnic Institute of Porto","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Active HD-tDCS + AR-Based Dichoptic Therapy","EXPERIMENTAL","Participants will receive augmented reality-based dichoptic therapy for 10 weeks, with 40-minute sessions four times per week. During the first 2 weeks, participants will also receive eight 20-minute sessions of active HD-tDCS applied to the primary visual cortex immediately before the augmented reality-based dichoptic therapy.",[13,14],"Device: Active High-Definition Transcranial Direct Current Stimulation","Device: Augmented Reality-Based Dichoptic Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham HD-tDCS + AR-Based Dichoptic Therapy","SHAM_COMPARATOR","Participants will receive the same augmented reality-based dichoptic therapy for 10 weeks, with 40-minute sessions four times per week. During the first 2 weeks, participants will also receive eight 20-minute sessions of sham HD-tDCS immediately before the augmented reality-based dichoptic therapy. Sham stimulation will use the same equipment, electrode placement, and initial ramping procedure as active stimulation, but no sustained current will be delivered.",[20,14],"Device: Sham High-Definition Transcranial Direct Current Stimulation",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Active High-Definition Transcranial Direct Current Stimulation","Active high-definition transcranial direct current stimulation will be delivered using a Soterix MxN-33 stimulator and a 4 × 1 electrode montage targeting the primary visual cortex. The central anodal electrode will be positioned at Oz, with four return electrodes positioned at PO3, PO4, PO7, and PO8. A current of 2.0 mA will be delivered for 20 minutes, including a 30-second ramp-up period at the beginning and a 30-second ramp-down period at the end of stimulation. Participants will receive eight sessions during the first 2 weeks, immediately before the augmented reality-based dichoptic therapy.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Sham High-Definition Transcranial Direct Current Stimulation","Sham high-definition transcranial direct current stimulation will use the same stimulator, electrode montage, electrode positions, and session duration as active stimulation. The current will be ramped up over 30 seconds at the beginning of the session and then ramped down over 30 seconds, with no sustained current delivered during the remainder of the session. Participants will receive eight 20-minute sessions during the first 2 weeks, immediately before the augmented reality-based dichoptic therapy.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Augmented Reality-Based Dichoptic Therapy","Augmented reality-based dichoptic therapy will be delivered using a Meta Quest 3 headset. Participants will complete 40-minute sessions four times per week for 10 weeks. The therapy presents different visual information to each eye and reduces the contrast presented to the stronger eye, giving the amblyopic eye a visual advantage and encouraging both eyes to work together. Visual acuity in the amblyopic eye will be assessed within the headset to guide adjustment of the contrast presented to the stronger eye. The augmented reality environment allows participants to interact with their real surroundings and perform everyday activities during therapy.",[9,16],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Catarina A Mateus, PhD","CONTACT","+351 962662157","cms@ess.ipp.pt",{"name":43,"role":39,"phone":44,"phoneExt":27,"email":45},"Rúben J Magalhães, MSc","+351 968918180","rjcm@ess.ipp.pt",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto","RECRUITING","Porto","Porto District","4200-072","Portugal","PT",{"type":56,"coordinates":57},"Point",[58,59],-8.61097,41.1485,{"lat":59,"lon":58},[62,66,69,72,74,76,78,80,82,84,86,88,90,92,94,96,98],{"name":63,"role":39,"phone":64,"phoneExt":27,"email":65},"Nuno B Rocha, PhD","+351 934540007","nrocha@ess.ipp.pt",{"name":67,"role":68,"phone":27,"phoneExt":27,"email":27},"Catarina Mateus, PhD","PRINCIPAL_INVESTIGATOR",{"name":70,"role":71,"phone":27,"phoneExt":27,"email":27},"Nuno Rocha, PhD","SUB_INVESTIGATOR",{"name":73,"role":71,"phone":27,"phoneExt":27,"email":27},"Rúben Magalhães, MSc",{"name":75,"role":71,"phone":27,"phoneExt":27,"email":27},"Simão Ferreira, PhD",{"name":77,"role":71,"phone":27,"phoneExt":27,"email":27},"Inês Pais, MSc",{"name":79,"role":71,"phone":27,"phoneExt":27,"email":27},"Natália Almeida-Antunes, PhD",{"name":81,"role":71,"phone":27,"phoneExt":27,"email":27},"Filipe Coelho, MSc",{"name":83,"role":68,"phone":27,"phoneExt":27,"email":27},"Miguel Castelo-Branco, MD, PhD",{"name":85,"role":71,"phone":27,"phoneExt":27,"email":27},"João Castelhano, PhD",{"name":87,"role":71,"phone":27,"phoneExt":27,"email":27},"Sónia Pires, BSc",{"name":89,"role":71,"phone":27,"phoneExt":27,"email":27},"Sónia Afonso, MSc",{"name":91,"role":71,"phone":27,"phoneExt":27,"email":27},"Miguel Raimundo, MD",{"name":93,"role":71,"phone":27,"phoneExt":27,"email":27},"Pedro Fonseca, MD",{"name":95,"role":71,"phone":27,"phoneExt":27,"email":27},"Laurie Goulet, PhD",{"name":97,"role":71,"phone":27,"phoneExt":27,"email":27},"Ivan Shcherbinin, MSc",{"name":99,"role":71,"phone":27,"phoneExt":27,"email":27},"Libânia Dias, BSc",{"type":68,"investigatorFullName":67,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Associate Professor",[103],{"name":104,"class":6},"University of Coimbra","100650865","combining-noninvasive-brain-stimulation-and-augmented-reality-based-dichoptic-therapy-for-treating-amblyopic-adults-100650865",false,"NCT07752433","Combining Noninvasive Brain Stimulation and Augmented Reality-based Dichoptic Therapy for Treating Amblyopic Adults","NiBS4Vision","Inclusion Criteria:\n\n* Age between 18 and 35 years.\n* Diagnosis of anisometropic amblyopia.\n* Unilateral amblyopia with an interocular difference of at least 2 lines in best-corrected visual acuity, with visual acuity worse than 20\u002F32 in the worse-seeing eye.\n\nExclusion Criteria:\n\n* Any type of amblyopia other than anisometropic amblyopia.\n* Bilateral amblyopia.\n* Ophthalmological or neuro-ophthalmological disease other than amblyopia.\n* Neurological disease.\n* Chronic pharmacological treatment.\n* Presence of an implanted medical device.\n* Any ocular surgery or treatment within the previous year.\n* Significant ocular media opacities.\n* Previous treatment with transcranial direct current stimulation or another non-invasive brain stimulation technique.\n* Pregnancy or planning to become pregnant during the study period.\n* Inability to provide informed consent.\n* History of head trauma, seizures, or frequent headaches.\n* Electrical or electronic implants, such as a cardiac pacemaker.\n* Metallic objects or implants in the head, except dental implants.","ALL","18 Years","40 Years",{"count":116,"type":117},80,"ESTIMATED","INTERVENTIONAL",[120],"NA","The goal of this clinical trial is to learn whether adding noninvasive brain stimulation to augmented reality-based vision therapy can improve vision in adults aged 18 to 40 years with unilateral anisometropic amblyopia, commonly called \"lazy eye.\" Anisometropic amblyopia develops during childhood when the two eyes have different focusing powers and the brain relies more on one eye than the other.\n\nThe main questions this study aims to answer are:\n\n* Does active high-definition transcranial direct current stimulation (HD-tDCS) improve best-corrected visual acuity in the amblyopic eye and depth perception more than sham stimulation?\n* Does the combined treatment improve contrast sensitivity, suppression between the eyes, and measures of retinal and visual brain function?\n\nAll participants will receive the same augmented reality-based dichoptic therapy. This therapy presents different visual information to each eye and lowers the contrast seen by the stronger eye. This gives the weaker, amblyopic eye a visual advantage and encourages both eyes to work together while participants carry out normal daily activities.\n\nDuring the first 2 weeks, participants will also receive either active HD-tDCS or sham stimulation immediately before the augmented reality therapy. Active HD-tDCS delivers a weak electrical current through small electrodes placed on the scalp. Sham stimulation uses the same equipment and procedures, but the current is applied only briefly at the beginning. Comparing the two groups will help researchers determine whether active brain stimulation provides additional benefits beyond those of augmented reality therapy alone.\n\nParticipants will:\n\n* Complete 40-minute augmented reality therapy sessions four times per week for 10 weeks.\n* Receive eight 20-minute sessions of active or sham HD-tDCS during the first 2 weeks, immediately before the augmented reality therapy.\n* Attend assessment visits before treatment, after 2 weeks, and after 10 weeks. These visits will include vision tests, retinal imaging, tests of retinal function, and brain imaging.",[123,124],"Amblyopia","Anisometropic Amblyopia",[126,124,127,128,129,130,131,132,133,134],"Adult Amblyopia","Dichoptic Therapy","Augmented Reality","Transcranial Direct Current Stimulation","High-Definition Transcranial Direct Current Stimulation","Noninvasive brain stimulation","Visual rehabilitation","Binocular vision","Neuroplasticity","2026-08-03",{"date":137,"type":138},"2026-08-07","ACTUAL",{"date":140,"type":138},"2025-05-01",{"date":142,"type":117},"2028-04-30",{"name":5,"class":6},1]