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

NCT06760910 | Recruiting DMC

• 1 other identifier: YK2023001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amblyopia

Keywords

Amblyopia; transcranial direct current stimulation(tDCs); adolescent; treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Changes in Visual Evoked Potential (VEP)

  24 weeks

• Improvements in contrast sensitivity at different spatial frequencies

  24 weeks

Study Arms (2)

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

Procedure: tDCS Stimulation; Device: Anodal tDCS

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

Procedure: tDCS Stimulation; Device: Sham tDCS

Interventions

tDCS Stimulation PROCEDURE

Anode tDCS or sham stimulation for amblyopia of Adolescents

Anodal tDCS Group; Sham Stimulation Group

Anodal tDCS DEVICE

Anodal tDCS

Anodal tDCS Group

Sham tDCS DEVICE

Sham tDCS

Sham Stimulation Group

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Amblyopia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: January 7, 2025
• Study Start: January 30, 2021
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)