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NCT Number: NCT06760910

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

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.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

10 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

Location contact

Yatu Guo

CONTACT

[email protected]

13902069596

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and their legal guardians have obtained consent in writing.
  • Participants aged 10-30, of any gender.
  • Participants must meet the diagnostic criteria for amblyopia: unilateral amblyopia with a difference of two lines or more in visual acuity between the eyes, or bilateral amblyopia with best-corrected visual acuity worse than 20/30 (or worse than 0.2 logMAR). The visual acuity charts to be used are LEA SYMBOLS® (Good-Lite Co., Elgin, IL) or HOTV visual acuity chart.

Exclusion criteria

  • Participants who may have eye diseases affecting vision or refractive errors (such as cataracts, crystalline lens damage, glaucoma, macular degeneration, corneal disorders, retinitis pigmentosa, retinal detachment, severe vitreous opacities, etc
  • History of eye trauma or intraocular surgery
  • Inability to cooperate with examinations
  • Presence of concomitant systemic diseases (such as epilepsy)
  • Participation in any other experimental treatment within the past 3 months
  • Other situations deemed unsuitable by the investigator.

Treatment and study plan

tDCS Stimulation

Procedure

Anode tDCS or sham stimulation for amblyopia of Adolescents

Anodal tDCS

Device

Anodal tDCS

Sham tDCS

Device

Sham tDCS

Primary outcomes

  1. Improvement in Best Corrected Visual Acuity (BCVA)

    Time frame: 24 weeks

    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.

Secondary outcomes

  1. Changes in Visual Evoked Potential (VEP)

    Time frame: 24 weeks

    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.

  2. Improvements in contrast sensitivity at different spatial frequencies

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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