Multi-day Effect of Noninvasive Brain Stimulation in Adults With Amblyopia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Amblyopia
- Sponsor
- Midwestern University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Crowded Visual Acuity
- Status
- Recruiting
- Last Updated
- last year
Overview
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:
- 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?
- 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:
- High-frequency transcranial random noise stimulation (hf-tRNS).
- 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.
Investigators
Arijit Chakraborty
Assistant Director of Research
Midwestern University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Crowded Visual Acuity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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.