An interventional study of tDCS Stimulation and Anodal tDCS in Amblyopia, sponsored by Tianjin Eye Hospital. Recruiting at 1 site in China. Open to participants aged 10 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Tianjin Eye Hospital · Not applicable, Interventional, and Treatment
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Tianjin Eye Hospital is the lead sponsor of 53 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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
Procedure: tDCS Stimulation · Device: Anodal tDCS
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
Procedure: tDCS Stimulation · Device: Sham tDCS
Anode tDCS or sham stimulation for amblyopia of Adolescents
Anodal tDCS
Sham tDCS
Improvement in Best Corrected Visual Acuity (BCVA)
quantified by the number of lines gained on a standard visual acuity chart(HOTV chart). This measure will be assessed at baseline, 3 months, and 6 months post-intervention. A line gain is defined as the ability to correctly read an additional row of optotypes compared to baseline measurements. The improvement will be evaluated separately for each eye and averaged to assess overall treatment efficacy.
Time frame: 24 weeks
Changes in Visual Evoked Potential (VEP)
changes in Visual Evoked Potential (VEP) metrics, specifically amplitude and latency, at 15 minutes and 1-degree visual angle stimulations. These measures will be used to assess the functional responsiveness of the visual pathways and cortical processing efficiency. Baseline, 3-month, and 6-month assessments will provide comparative data to evaluate the neurophysiological effects of the intervention.
Time frame: 24 weeks
Improvements in contrast sensitivity at different spatial frequencies
Contrast sensitivity will be evaluated using a contrast sensitivity test with CSV-1000E(Vector vision, US), which measures the ability to detect differences in luminance across varying spatial frequencies (low 3 c/d, medium 6c/d、12 c/d, and high 18 c/d). Assessments will be conducted at baseline, 3 months, and 6 months post-intervention. The degree of improvement will be compared across groups to determine the impact of tDCS on visual function beyond acuity.
Time frame: 24 weeks
Plan to share: No
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Tianjin Eye Hospital