Effectiveness of tDCS in Paediatric Amblyopia.

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. The main questions it aims to answer are: Does tDCS produce significant and sustained improvements in visual acuity, contrast sensitivity, and stereopsis in children with amblyopia? Is tDCS a safe, well-tolerated, and faster alternative or complementary treatment compared with standard occlusion therapy? Does tDCS induce functional and structural changes in the visual cortex associated with increased neuroplasticity, including modulation of GABAergic activity? If there is a comparison group: Researchers will compare active tDCS with sham (placebo) stimulation to see if active treatment leads to greater visual recovery and cortical changes than placebo. Participants will: Receive several sessions of active or sham tDCS using low-intensity electrical stimulation applied to visual brain areas. Undergo standard visual assessments, including visual acuity, contrast sensitivity, and stereopsis. Complete neurophysiological and neuroimaging evaluations (EEG, pattern visual evoked potentials, and functional MRI). Provide biochemical measures related to GABA levels. This 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.

NCT Number	NCT07547670
Lead Sponsor	Universidad de Murcia Collaborators: Hospital Universitario Virgen de la Arrixaca, Hospital Universitario Reina Sofia de Cordoba, Hospital General Universitario Morales Meseguer
Conditions	Amblyopia, Amblyopia Strabismic, Visual Acuity, Stereoscopic Vision
Enrollment	100 participants
Start Date	2026-05-02
Primary Completion	2026-06-01 (estimated)
Study Completion	2029-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-28