Noninvasive Brain Stimulation in Adult Amblyopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sham Transcranial Random Noise Stimulation, High Frequency Transcranial Random Noise Stimulation.
- Who it may be relevant to
- Registry conditions: Amblyopia. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-day Effect of Noninvasive Brain Stimulation in Adults With Amblyopia
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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).]
- 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).]
- 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).]
- 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).]
- 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).]
- 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).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Midwestern University Eye Institute — Downers Grove
Publications
- 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. PMID 26763954
- 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. PMID 18635353
- 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. PMID 22415915
- 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. PMID 23664756
Identifiers
NCT: NCT06712849 · CIRB-IL 23044