Effectiveness of tDCS in Paediatric Amblyopia.

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Amblyopia, Amblyopia Strabismic, Visual Acuity, Stereoscopic Vision

In brief

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.

Key facts

Study ID

NCT07547670

Run by

Universidad de Murcia

People needed

100

Starts

2026-05-02

Expected to finish

2029-08-31

Last updated by the study team

2026-07-28

Who can join

Age: 4 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 4-14 years.
• Strabismic amblyopia resistant to patching (PEDIG criteria).
• Anisometropic amblyopia resistant to patching (PEDIG criteria).

You may not qualify if…

• Ocular pathology.
• Nystagmus.
• Mental disability.
• Cognitive delay.
• Neurological problems incompatible with treatment.
• Pacemakers.
• Intracranial electrodes.
• Implanted defibrillators.
• Cranial pathologies.
• Cranial lesions.
• Withdrawal will occur upon adverse events, protocol deviation, refusal, or loss to follow-up.

Where it is running

• University of Murcia — Murcia, Spain (enrolling)

Full record on ClinicalTrials.gov

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