Noninvasive Brain Stimulation in Adult Amblyopia

Not Applicable

Recruiting

• Conditions: Amblyopia

• Registration Number: NCT06712849
• Lead Sponsor: Midwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Status Verified: 2024-12
• Study First Posted: 2024-12-02
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adults between 18 and 55 years of age
• Formal diagnosis of amblyopia in one or both eyes of any etiology

Exclusion Criteria

• History of optic nerve disease, including glaucoma and optic neuritis
• History of neurological conditions, including demyelinating disease or stroke
• Presence of metal or electronic implants in or on the body, including pacemakers
• Taking medications that can affect normal neurological function, including antipsychotics, antiepileptics, and opioids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Crowded Visual Acuity	Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).	A change in crowded visual acuity is measured in LogMAR from baseline.
Stereo Acuity	Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).	A change in stereo acuity is measured in arc seconds from baseline.
Phosphene Threshold	Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).	A change in phosphene threshold (%) from baseline.
Global Motion Perception	Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).	A change in global motion perception coherence threshold (%) from baseline.
Form Pattern Recognition	Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).	A change in form pattern recognition coherence threshold (%) from baseline.
Pattern-reversal Visual Evoked Potentials (pVEP)	Pre-treatment (Day 1); post-treatment (Day 5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).	A change in N75-P100 amplitudes and P100 latencies from baseline.

Trial Locations

Locations (1)

Midwestern University Eye Institute; 🇺🇸 Downers Grove, Illinois, United States