Actively Recruiting

Phase Not Applicable
Age: 10Years - 30Years
All Genders
Healthy Volunteers
ID06760910

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

Led by Tianjin Eye Hospital · Updated on 2025-01-07

40

Participants Needed

1

Research Sites

30 weeks

Total Duration

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AI-Summary

What this Trial Is About

Amblyopia, a neurodevelopmental visual disorder, especially the monocular form-deprivation type, can cause serious impairments in visual development. Older children and adults with amblyopia often respond poorly to standard treatments due to reduced brain plasticity after the critical development period. Researchers are studying transcranial direct current stimulation (tDCS) to see if it can improve visual function by enhancing brain plasticity and activity in the visual cortex of these patients. The study compares two groups: one receiving anodal tDCS and the other receiving sham (placebo) stimulation. Both treatments involve placing electrodes over the occipital cortex and delivering sessions twice a week for 20 minutes each, over a period of 6 months. The active stimulation is set at 0.1 mA, while the sham group receives 0 mA, simulating treatment without actual stimulation. Functional MRI scans will be done before and after to assess changes in brain activity and connectivity related to vision. Participants will undergo assessments of their best corrected visual acuity, visual evoked potentials, and contrast sensitivity at the start and after 24 weeks of treatment. Researchers will also monitor brain activity changes using resting-state and task-based functional MRI. The study aims to provide clear evidence on how tDCS affects visual function and brain plasticity in older adolescents with amblyopia. The total duration of participation is 6 months of treatment with follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and their legal guardians have provided written consent.
  • Participants aged 10 to 30 years, any gender.
  • Diagnosis of amblyopia with two or more lines difference in visual acuity between eyes, or bilateral amblyopia with best-corrected visual acuity worse than 20/30 using LEA SYMBOLS® or HOTV visual acuity charts.
Not Eligible

You will not qualify if you...

  • Presence of other eye diseases affecting vision such as cataracts, lens damage, glaucoma, macular degeneration, corneal disorders, retinitis pigmentosa, retinal detachment, or severe vitreous opacities.
  • History of eye trauma or intraocular surgery.
  • Inability to cooperate with examinations.
  • Presence of systemic diseases like epilepsy.
  • Participation in any other experimental treatment within the past 3 months.
  • Other conditions judged unsuitable by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 months

Participants receive either anodal transcranial direct current stimulation (tDCS) or sham stimulation with electrodes placed over the occipital cortex to treat amblyopia.

Twice weekly visits for stimulation sessions

Trial Site Locations

Total: 1 location

1

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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