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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Stimulation | Sham Comparator | 40-minute sessions of sham stimulation for 5 consecutive days. |
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| hf-tRNS Stimulation | Active Comparator | 40-minute sessions of hf-tRNS stimulation for 5 consecutive days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Transcranial Random Noise Stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Crowded Visual Acuity | A change in crowded visual acuity is measured in LogMAR from baseline. | 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. | 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. | 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. | 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. | 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arijit Chakraborty, PhD | Contact | 630-960-3172 | achakr@midwestern.edu | |
| Adrienne C Quan, OD | Contact | 630-960-3183 | aquan@midwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwestern University Eye Institute | Recruiting | Downers Grove | Illinois | 60515 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26763954 | Background | Ding Z, Li J, Spiegel DP, Chen Z, Chan L, Luo G, Yuan J, Deng D, Yu M, Thompson B. The effect of transcranial direct current stimulation on contrast sensitivity and visual evoked potential amplitude in adults with amblyopia. Sci Rep. 2016 Jan 14;6:19280. doi: 10.1038/srep19280. | |
| 18635353 | Background | Thompson B, Mansouri B, Koski L, Hess RF. Brain plasticity in the adult: modulation of function in amblyopia with rTMS. Curr Biol. 2008 Jul 22;18(14):1067-71. doi: 10.1016/j.cub.2008.06.052. |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| High Frequency Transcranial Random Noise Stimulation | Device | 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. |
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| 22415915 | Background | Thompson B, Mansouri B, Koski L, Hess RF. From motor cortex to visual cortex: the application of noninvasive brain stimulation to amblyopia. Dev Psychobiol. 2012 Apr;54(3):263-73. doi: 10.1002/dev.20509. Epub 2010 Nov 8. |
| 23664756 | Background | Clavagnier S, Thompson B, Hess RF. Long lasting effects of daily theta burst rTMS sessions in the human amblyopic cortex. Brain Stimul. 2013 Nov;6(6):860-7. doi: 10.1016/j.brs.2013.04.002. Epub 2013 Apr 28. |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |