An interventional study of Sham Transcranial Random Noise Stimulation and High Frequency Transcranial Random Noise Stimulation in Amblyopia, sponsored by Midwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Midwestern University · Not applicable, Interventional, and Treatment
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:
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:
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Midwestern University is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
40-minute sessions of sham stimulation for 5 consecutive days.
Device: Sham Transcranial Random Noise Stimulation
40-minute sessions of hf-tRNS stimulation for 5 consecutive days.
Device: High Frequency 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.
Also known as: Sham tRNS
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.
Also known as: tRNS, hf-tRNS
Crowded Visual Acuity
A change in crowded visual acuity is measured in LogMAR from baseline.
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).
Stereo Acuity
A change in stereo acuity is measured in arc seconds from baseline.
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).
Phosphene Threshold
A change in phosphene threshold (%) from baseline.
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).
Global Motion Perception
A change in global motion perception coherence threshold (%) from baseline.
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).
Form Pattern Recognition
A change in form pattern recognition coherence threshold (%) from baseline.
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).
Pattern-reversal Visual Evoked Potentials (pVEP)
A change in N75-P100 amplitudes and P100 latencies from baseline.
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).
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Midwestern University