Noninvasive Brain Stimulation for Lazy Eye (NIBSAAM Trial)

N/A

Recruiting

Research Sponsored by Midwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Formal diagnosis of amblyopia in one or both eyes of any etiology

Adults between 18 and 55 years of age

Must not have

History of optic nerve disease, including glaucoma and optic neuritis

History of neurological conditions, including demyelinating disease or stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Summary

"This trial aims to study the effectiveness of non-invasive brain stimulation in treating adults with amblyopia, a condition where one eye has weaker vision than the other. They want to see if this stimulation

Who is the study for?

This trial is for adults with amblyopia, commonly known as lazy eye. Participants should be interested in a non-surgical treatment option and available for five consecutive days of stimulation sessions. Specific eligibility details are not provided but typically include age range, severity of amblyopia, and general health requirements.

What is being tested?

The study tests if brain stimulation can improve vision in adults with lazy eye. It compares high-frequency transcranial random noise stimulation (hf-tRNS) against sham (fake) treatment over five days to see if there's any improvement in visual functions like acuity and perception.

What are the potential side effects?

While the description doesn't list side effects, non-invasive brain stimulation may cause mild discomfort or headache at the site of application, temporary changes in vision or mood, fatigue or dizziness post-treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with lazy eye.

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of optic nerve disease, such as glaucoma.

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I have a history of neurological conditions like multiple sclerosis or stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.