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Effectiveness of tDCS in Paediatric Amblyopia.

Study acronym: tDCS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened
    • Study sites: 0 to 1
    • Primary completion date changed from estimate of Jun 30, 2026 to Jun 1, 2026
    • Start date changed from estimate of Jun 1, 2026 to May 2, 2026
    v3
  2. Minor Eligibility criteria shortened, about 21 wordsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)
Amblyopia, Amblyopia Strabismic, Visual Acuity, Stereoscopic Vision
Related terms Amblyopia
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov