NCT06760910

Clinical Treatment of Transcranial Direct Current Stimulation in Older Adolescents With Amblyopia

Efficacy of Transcranial Direct Current Stimulation in the Amblyopia Treatment of Older Adolescents: A Cohort Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tianjin Eye Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 30 Years
• Healthy volunteers: Accepted

Summary

As a neurodevelopmental visual disorder, amblyopia, especially monocular form-deprivation amblyopia, can lead to severe visual developmental impairments. Due to reduced neural plasticity in the visual cortex after the critical period of visual development, older children and adults with amblyopia show poor responses to conventional treatments, lacking effective therapeutic options. Recent basic and clinical research has shown that transcranial direct current stimulation can effectively treat adult amblyopia by altering cortical excitability, enhancing synaptic plasticity, and affecting the excitatory/inhibitory balance in the cortex to reboot adult visual cortex plasticity. This proposed study aims to conduct a large-scale prospective randomized controlled trial to objectively assess the efficacy and safety of transcranial direct current stimulation in treating amblyopia in older adolescents and adults. By comparing changes in best-corrected visual acuity, visual evoked potentials(VEPs), contrast sensitivity, and functional connectivity between the visual cortex and other cortical areas using fMRI, the study seeks to provide robust clinical evidence, clarify the treatment effects of transcranial direct current stimulation in adult amblyopia, elucidate potential mechanisms of enhancing adult visual cortex plasticity with transcranial direct current stimulation, and potentially offer a safe and effective treatment modality for adult amblyopia.

Detailed description

1. A prospective cohort study designed to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in improving visual outcomes in older adolescents with amblyopia. Anodal tDCS Group: Participants will receive anodal transcranial direct current stimulation (tDCS) with electrodes placed over the occipital cortex, chosen due to its critical role in processing visual information and its potential responsiveness to neuromodulation in amblyopia treatment. The stimulation will be set at 0.1 mA for 20 minutes per session, twice a week, over 6 months; Sham Stimulation Group: Participants will receive sham tDCS with electrodes similarly placed over the occipital cortex. The stimulation will be set at 0 mA for 20 minutes per session, twice a week, over 6 months. 2. The impact of transcranial direct current stimulation on adult visual cortex plasticity and cortical functional assessment. Before and after transcranial direct current stimulation, resting-state and task-based functional magnetic resonance imaging (fMRI) are used to assess the functional activity between the visual cortex and other cortical regions. This evaluation aims to identify changes in adult visual cortex plasticity.

Conditions

• Amblyopia

Interventions

Type	Name	Description
PROCEDURE	tDCS Stimulation	Anode tDCS or sham stimulation for amblyopia of Adolescents
DEVICE	Anodal tDCS	Anodal tDCS
DEVICE	Sham tDCS	Sham tDCS

Timeline

• Start date: 2021-01-30
• Primary completion: 2026-05-30
• Completion: 2026-12-30
• First posted: 2025-01-07
• Last updated: 2025-01-07

Locations

1 site across 1 country: China