Evaluating the Safety and Effectiveness of Transcranial Direct Current Stimulation to Improve Vision in Children Ages 4 to 14 with Resistant Strabismic or Anisometropic Amblyopia

What this Trial Is About

Researchers are studying children aged 4 to 14 years with strabismic or anisometropic amblyopia that has not improved with standard patching therapy. This randomized, double-blind trial aims to evaluate whether transcranial direct current stimulation tDCS, a non-invasive brain stimulation technique, can improve vision measures like visual acuity, contrast sensitivity, and stereoscopic vision. The study also investigates whether tDCS is a safe and well-tolerated alternative or complement to traditional occlusion therapy and examines its effects on brain function and structure related to neuroplasticity. Participants receive either active tDCS or a sham placebo stimulation using low-intensity electrical currents applied via electrodes placed on the scalp over visual brain areas. The active treatment involves gradually increasing the current to 2 mA, maintaining it for 15 minutes, and then decreasing it, repeated across three sessions spaced 48 hours apart. Both groups undergo the same procedures, including standard visual tests and neurophysiological and neuroimaging assessments such as EEG, pattern visual evoked potentials, and functional MRI, along with biochemical measures related to GABA levels. During the study, children will have their vision evaluated through tests of visual acuity, stereopsis, contrast sensitivity, and eye fixation at baseline and at 3 months after treatment. Brain activity and structural changes will be monitored through advanced imaging and biochemical tests. Researchers will carefully observe safety and tolerability throughout. The study aims to confirm whether tDCS can offer a faster, child-friendly treatment option for amblyopia that could be incorporated into pediatric clinical practice. Total participation spans at least three months post-treatment for outcome assessment.

Effectiveness of tDCS in Paediatric Amblyopia.