NCT06712849

Noninvasive Brain Stimulation in Adult Amblyopia

Multi-day Effect of Noninvasive Brain Stimulation in Adults With Amblyopia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Midwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized controlled trial is to investigate the effectiveness of non-invasive brain stimulation in treating adults with amblyopia. The main questions it aims to answer are: 1. What are the effects of non-invasive brain stimulation on neuronal plasticity in the visual cortex of adults with amblyopia, and does it produce lasting changes? 2. Do cumulative sessions of non-invasive brain stimulation influence neural plasticity and higher-order visual functions in adults with amblyopia? The investigators hypothesize that non-invasive brain stimulation will show a positive cumulative effect after five (5) consecutive days of stimulation on visual perception and function in adults with amblyopia. Participants will be randomized into one of two treatment groups: 1. High-frequency transcranial random noise stimulation (hf-tRNS). 2. Sham stimulation. Researchers will compare baseline measurements of crowded visual acuity, contrast sensitivity, stereoacuity, phosphene thresholds, global motion perception, form pattern recognition and pattern-reversal visual evoked potentials (VEPs) to post-treatment measurements for each group.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Sham Transcranial Random Noise Stimulation	Sham transcranial random noise stimulation will be applied over the primary visual cortex (area V1) with the current ramping up for 20 seconds before ramping down for 20 seconds. The 2.0 milliamp current stimulation will occur for only a few seconds at the start and at the end of the 40 minutes.
DEVICE	High Frequency Transcranial Random Noise Stimulation	Non-invasive brain stimulation will involve the use of high-frequency transcranial random noise stimulation (100-640 Hz) to apply a 2.0 milliamp current over the primary visual cortex (area V1) for approximately 40 minutes with a ramp up to the maximum programmed current and ramp down of 20 seconds.

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2024-12-02
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study