Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-05-01
2028-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham Stimulation
40-minute sessions of sham stimulation for 5 consecutive days.
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.
hf-tRNS Stimulation
40-minute sessions of hf-tRNS stimulation for 5 consecutive days.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Formal diagnosis of amblyopia in one or both eyes of any etiology
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Midwestern University
OTHER
Responsible Party
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Arijit Chakraborty
Assistant Director of Research
Locations
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Midwestern University Eye Institute
Downers Grove, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Sherri Olsen
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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CIRB-IL 23044
Identifier Type: -
Identifier Source: org_study_id