NCT05016830

Bilateral Transcranial Direct Current Stimulation and Ocular Occlusion for Adults With Amblyopia

Effect of the Combination of tDCS and Visual Occlusion Therapy on Visual Acuity, Contrast Vision and Depth Vision, in Adult Patients With Amblyopia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A prospective interventional study is expected to be conducted, to test a possible new treatment for amblyopia (lazy eye syndrome). Bilateral transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation, which may help in visual function recovery of adult patients with amblyopia. This pilot study will test the feasibility of said therapy, along with the short term effects of bilateral tDCS in visual function.

Detailed description

Theoretical Framework: Ocular occlusion treatment has been used classically and with excellent results for the treatment of amblyopia in those under 14 years of age, since in this period it has been seen that there is greater neuroplasticity, leaving little to do in the period of lower neuroplasticity, in young and adult patients with later diagnoses. Transcranial Direct Current Stimulation therapy is an emergent technique used in neurological diseases to increase neuroplasticity, by changing the resting potential of neurons. Our hypothesis is that the combination of tDCS and visual occlusion therapy is capable of increasing visual acuity, contrast sensitivity, and depth perception, in young people over 18 years of age. Methodology: The application of a double-blind, randomized clinical trial is proposed to evaluate the application of 2 different therapies: Occlusion with bilateral tDCS, and Occlusion with tDCS sham (sham). The study subjects will be randomly assigned to a group, and one session of stimulation will be performed. Data will be analyzed using Student's t test, or Mann-Whitney test, according to the normal or non-normal distribution of the sample, respectively. Also, the change over time of the variables will be measured using the Conditional Change Model. Expected Results: The investigators expect that visual acuity, contrast vision, and dichoptic vision in the Occlusion therapy group with bilateral tDCS will be significantly higher than the Occlusion therapy group with tDCS sham (sham).

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Bilateral transcranial direct current stimulation	A direct current is applied with two electrodes (cathode and anode) in specific parts of the skull. In this case the anode was over the occipital area to target the amblyopic cortex, while the cathode was over the contralateral side, targeting the fellow cortex.

Timeline

• Start date: 2019-11-05
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2021-08-23
• Last updated: 2021-08-23

Locations

1 site across 1 country: Chile