Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 6:18 PM
Study NCT ID:
NCT04213066
Status:
COMPLETED
Last Update Posted:
2019-12-30
First Post:
2019-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
Sponsor:
National Cheng-Kung University Hospital
Organization:
Study Overview
Official Title:
Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: