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Effectiveness of tDCS in Paediatric Amblyopia.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 14
Healthy Volunteers: f
View:

• Children aged 4-14 years.

• Strabismic amblyopia resistant to patching (PEDIG criteria).

• Anisometropic amblyopia resistant to patching (PEDIG criteria).

Locations
Other Locations
Spain
University of Murcia
RECRUITING
Murcia
Contact Information
Primary
Dr. Francisco Javier Valiente Soriano, Optics and Optometry
fjvaliente@um.es
+34 670 25 58 48
Time Frame
Start Date: 2026-05-02
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 100
Treatments
Experimental: Group tDCS
Children aged 4 to 14 with amblyopia treated at one of the collaborating hospitals and centers, with visual acuity in the amblyopic eye between 20/32 and 20/200. They will undergo tests of visual acuity, stereoscopic visual acuity, fixation, and contrast sensitivity. The direct current will be gradually increased over 34 seconds to 2 mA, held constant for 15 minutes, and then gradually reduced to zero using NIC2® v2.1.2.0 software (Neuroelectrics®, Barcelona, Spain). The stimulating current is applied using two rubber electrodes housed in circular sponge pockets (8 cm² each) soaked in saline solution. The electrodes are placed at Oz (active/stimulating electrode, located in the visual cortex) and Cz (reference electrode).
Sham_comparator: Group Sham
The sham group is equipped with the same electrostimulation helmet, but the intensity protocol is set to 0 at all times. The same measurements are taken and exactly the same procedure is followed as with the experimental group.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital General Universitario Morales Meseguer, Hospital Universitario Reina Sofia de Cordoba, Hospital Universitario Virgen de la Arrixaca
Leads: Universidad de Murcia

This content was sourced from clinicaltrials.gov

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