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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS Group | Active Comparator | 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 |
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| Sham Stimulation Group | Sham Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS Stimulation | Procedure | Anode tDCS or sham stimulation for amblyopia of Adolescents |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Anodal tDCS | Device | Anodal tDCS |
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| Sham tDCS | Device | Sham tDCS |
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| 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. | 24 weeks |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |