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Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04213066
Recruitment Status : Completed
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

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.


Condition or disease Intervention/treatment Phase
Amblyopia Amblyopia, Anisometropic Device: Portable tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
Actual Study Start Date : July 15, 2013
Actual Primary Completion Date : January 31, 2016
Actual Study Completion Date : January 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Active Comparator: Control group
This group received eye-hand practice for drawing pictures.
Device: Portable tablet
Each training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months.

Experimental: Grating group
This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies.
Device: Portable tablet
Each training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months.

Experimental: Random dot group
This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies constructed by random dots of stochastic resonance.
Device: Portable tablet
Each training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months.




Primary Outcome Measures :
  1. Visual acuity (VA) [ Time Frame: Change from Baseline VA at 1, 2, 3 and 6 months ]
    Landolt C chart was used.

  2. Grating acuity (GA) [ Time Frame: Change from Baseline GA at 1, 2, 3 and 6 months ]
    Horizontal or vertical square-wave grating stimuli were used.

  3. Contrast sensitivity (CS) [ Time Frame: Change from Baseline CS at 1, 2, 3 and 6 months ]
    Circular-shape horizontal square-wave grating stimuli were used.

  4. Visual evoked potential (VEP) [ Time Frame: Change from Baseline VEP at 1, 2, 3 and 6 months ]
    Transient VEP and Steady state VEP of the Cortical EEG were recorded.


Secondary Outcome Measures :
  1. Total practice duration [ Time Frame: Throughout 6 months ]
    Practice duration was recorded in the tablet.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213066


Sponsors and Collaborators
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Fu-Zen Shaw, Professor Department of Pyschology, National Cheng Kung University
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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT04213066    
Other Study ID Numbers: A-BR-102-050-t
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cheng-Kung University Hospital:
Amblyopia
Amblyopic training
Contrast sensitivity
Grating acuity
Stochastic resonance
Visual acuity
Visual evoked potential
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases