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Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04213066
Enrollment
51
Registered
2019-12-30
Start date
2013-07-15
Completion date
2016-01-31
Last updated
2019-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia, Amblyopia, Anisometropic

Keywords

Amblyopia, Amblyopic training, Contrast sensitivity, Grating acuity, Stochastic resonance, Visual acuity, Visual evoked potential

Brief summary

The prevalence of Taiwan's population with amblyopia is 2-5%. Amblyopia affects the daily life and learning ability. The human visual system can be developed normally with exposure of clear images on the retina, which often drive the development and projection of optic nerves progressively. In general, the visual acuity progresses gradually with age. A normal vision is relatively mature until 8 years old. Several types of amblyopia (strabismic amblyopia, refractive amblyopia, and deprivation amblyopia) are identified. The refractive amblyopia and deprivation amblyopia must be corrected by wearing glasses or surgeries. Otherwise, amblyopia is often corrected by occlusion of the dominant eye or amblyopia training. The Cambridge Stimulator (CAM) with rotating grating is commonly used in clinic in Taiwan. The principle of the CAM allows subjects to draw pictures on the plate in coincidence with occlusion of the dominant eye. The parents have to go with their children to a hospital weekly. The CAM training is a stereotyped visuomotor behavior, which usually causes fatigue and uninteresting results for children. Recently, some computer games have been incorporated with CAM training. However, their clinical impact on amblyopia is largely unknown. Moreover, most of studies don't have long-term tracking, and they only use limited assessments. In this project, a home-based training would be built for children with amblyopia. A CAM training with a hierarchical structure with story-based organization would be implemented in the tablet. It will save time for children and parents for traffic between the home and hospital. The CAM training with organized structure would increase acceptability and create subjects' motivation for long-term training. In addition, a stochastic resonance theory would be incorporated with the CAM training to potentiate the learning curve of a visuomotor skill in young children. Five systematic assessments, including visual acuity, grating acuity, contrast sensitivity, and 2 measurements of visual evoked potentials (VEPs), would be used. The investigators hypothesized that the rotating grating stimulation and stochastic resonance stimulation groups showed significant enhancement of the visual functions compared with the control group and performance of the VEPs toward better eye through the home-based training apparatus.

Interventions

DEVICEPortable tablet

Each training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months.

Sponsors

Chang Gung Memorial Hospital
CollaboratorOTHER
National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

1. Participants were 4-8 years old. 2. Participant had binocular or monocular best-corrected visual acuity (BCVA) of ≤0.8, or they exhibited binocular BCVA difference of ≥0.2. 3. Participant had the wearing of optimal spectacle correction.

Exclusion criteria

1. Children with deprivation amblyopia were excluded. 2. Children with ptosis were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Contrast sensitivity (CS)Change from Baseline CS at 1, 2, 3 and 6 monthsCircular-shape horizontal square-wave grating stimuli were used.
Visual evoked potential (VEP)Change from Baseline VEP at 1, 2, 3 and 6 monthsTransient VEP and Steady state VEP of the Cortical EEG were recorded.
Visual acuity (VA)Change from Baseline VA at 1, 2, 3 and 6 monthsLandolt C chart was used.
Grating acuity (GA)Change from Baseline GA at 1, 2, 3 and 6 monthsHorizontal or vertical square-wave grating stimuli were used.

Secondary

MeasureTime frameDescription
Total practice durationThroughout 6 monthsPractice duration was recorded in the tablet.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026