Effectiveness of tDCS in Paediatric Amblyopia.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-14
SponsorUniversidad de Murcia

About this trial

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.

Eligibility criteria

Qualifiers

Children aged 4-14 years.

Strabismic amblyopia resistant to patching (PEDIG criteria).

Anisometropic amblyopia resistant to patching (PEDIG criteria).

Disqualifiers

Ocular pathology.

Nystagmus.

Mental disability.

Cognitive delay.

Trial design

Treatments tested in this trial

  • tDCS

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Universidad de Murcia

Lead sponsor

Hospital Universitario Virgen de la Arrixaca

Collaborator

Hospital Universitario Reina Sofia de Cordoba

Collaborator

Hospital General Universitario Morales Meseguer

Collaborator