Noninvasive Brain Stimulation for Lazy Eye

(NIBSAAM Trial)

Overseen By Adrienne C Quan, OD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Midwestern University

Must not be taking: Antipsychotics, Antiepileptics, Opioids

Disqualifiers: Optic nerve disease, Neurological conditions, Implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 week

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether non-invasive brain stimulation can improve vision in adults with amblyopia, also known as lazy eye. Researchers aim to determine if this method has lasting effects on the brain's processing of visual information. Participants will receive either real stimulation (High-Frequency Transcranial Random Noise Stimulation) or a placebo-like sham treatment for comparison. Adults with a formal diagnosis of amblyopia are suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for amblyopia.

Will I have to stop taking my current medications?

If you are taking medications that affect normal neurological function, like antipsychotics, antiepileptics, or opioids, you may need to stop taking them to participate in this trial.

What prior data suggests that non-invasive brain stimulation is safe for treating amblyopia?

Research has shown that high-frequency transcranial random noise stimulation (hf-tRNS) is generally safe for people. A study on its use in adults with amblyopia, or "lazy eye," found improvements in vision without serious side effects. Participants attended daily sessions, and no major negative effects were reported. This suggests that hf-tRNS is a safe option for those considering joining a trial for amblyopia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using High Frequency Transcranial Random Noise Stimulation (hf-tRNS) for treating lazy eye, or amblyopia, because it's a non-invasive and potentially faster alternative to traditional treatments like eye patches or corrective lenses. Unlike these standard methods, which can take weeks or even months to show significant improvement, hf-tRNS involves short, daily sessions over just five days. This technique works by gently stimulating the brain with random electrical noise, which may enhance neural plasticity and improve visual processing. If successful, hf-tRNS could offer a quicker, less cumbersome option for patients compared to the conventional approaches.

What evidence suggests that non-invasive brain stimulation is effective for treating amblyopia?

Research has shown that high-frequency transcranial random noise stimulation (hf-tRNS), a treatment that participants in this trial may receive, can significantly improve vision in adults with amblyopia, also known as lazy eye. Studies have found that this treatment clarifies vision and helps individuals distinguish objects more distinctly from their background. One study reported improved vision after just five days of treatment. Although amblyopia has long been considered untreatable in adults, these findings suggest that hf-tRNS could be a promising new method to enhance vision. Participants in this trial may also receive sham stimulation as a comparator. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with lazy eye.

Exclusion Criteria

I am taking medication that can affect my brain function, like antipsychotics or opioids.

Presence of metal or electronic implants in or on the body, including pacemakers

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either high-frequency transcranial random noise stimulation (hf-tRNS) or sham stimulation for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in visual functions and neural plasticity post-treatment

2 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High Frequency Transcranial Random Noise Stimulation
• Sham Transcranial Random Noise Stimulation

Trial Overview

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.

How Is the Trial Designed?

Group I: hf-tRNS Stimulation Active Control 1 Intervention

40-minute sessions of hf-tRNS stimulation for 5 consecutive days.

Group II: Sham Stimulation Placebo Group 1 Intervention

40-minute sessions of sham stimulation for 5 consecutive days.

Who Is Running the Clinical Trial?

Midwestern University

Lead Sponsor

Trials

24

Recruited

3,500+

Published Research Related to This Trial

Random noise stimulation, which uses unpredictable energy forms like electrical or mechanical stimuli, has shown promise in enhancing sensory, motor, and cognitive functions, particularly through techniques like transcranial random noise stimulation.

This technique has potential applications in treating various neurological disorders, including ADHD, schizophrenia, and post-stroke recovery, but further randomized controlled trials are needed to optimize its effectiveness and validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Random noise stimulation in the treatment of patients with neurological disorders. Herrera-Murillo, MA., Treviño, M., Manjarrez, E.[2022]

In a study with 15 healthy participants, both 1-mA and 2-mA transcranial direct current stimulation (tDCS) significantly increased motor cortical excitability, as measured by motor-evoked potentials, compared to baseline.

Transcranial random noise stimulation (tRNS) alone did not enhance cortical excitability, suggesting that the addition of a direct current offset is necessary for effective stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of transcranial random noise stimulation and transcranial direct current stimulation on motor cortical excitability. Ho, KA., Taylor, JL., Loo, CK.[2015]

Transcranial random noise stimulation (tRNS) is a non-invasive method that can effectively modulate perception and enhance learning in individuals, indicating its potential as a therapeutic tool.

While tRNS shows promise for improving brain function, its effects on higher cognitive processes are inconsistent, suggesting that further research is needed to understand its long-term benefits and mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. van der Groen, O., Potok, W., Wenderoth, N., et al.[2022]

Transcranial random noise stimulation (tRNS) applied to the auditory cortex significantly increased auditory steady state responses (ASSRs) in healthy subjects, indicating enhanced excitability of the auditory cortex.

The study involved 14 participants in a placebo-controlled design, and while there was a notable increase in ASSR at 40 Hz, changes in resting state theta band power were not statistically significant, suggesting tRNS may selectively enhance certain auditory processing functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. Van Doren, J., Langguth, B., Schecklmann, M.[2022]

In a study involving 22 healthy subjects, neither high-frequency nor low-frequency transcranial random noise stimulation (tRNS) produced significant changes in auditory steady state responses (ASSR) or resting state EEG activity, suggesting limited efficacy of tRNS in modulating these brain activities.

Interestingly, the sham tRNS condition led to a significant decrease in 20Hz ASSR and an increase in alpha frequency band activity, indicating that the act of stimulation itself, even without active tRNS, may influence brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological evaluation of high and low-frequency transcranial random noise stimulation over the auditory cortex. Schoisswohl, S., Langguth, B., Gebel, N., et al.[2021]

In a study involving 19 adults with amblyopia, five days of transcranial random noise stimulation (tRNS) significantly improved contrast sensitivity and uncrowded visual acuity in the amblyopic eye, while sham stimulation showed no effects.

Although initial improvements were noted on the first day of stimulation, the benefits did not persist across multiple sessions, except for a lasting enhancement in uncrowded visual acuity observed at a 28-day follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive visual cortex transcranial random noise stimulation in adults with amblyopia. Donkor, R., Silva, AE., Teske, C., et al.[2021]

In a randomized, double-blind, sham-controlled trial involving 36 stabilized schizophrenia patients, high-frequency transcranial random noise stimulation (hf-tRNS) significantly reduced negative symptoms, with a large effect size (Cohen's d = 2.16) and lasting benefits observed for up to one month.

The treatment was found to be safe and also showed improvements in related symptoms such as disorganization and awareness of negative symptoms, although it did not affect neurocognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunct high-frequency transcranial random noise stimulation over the lateral prefrontal cortex improves negative symptoms of schizophrenia: A randomized, double-blind, sham-controlled pilot study. Chang, CC., Lin, YY., Tzeng, NS., et al.[2021]

In a study involving human subjects trained over 4 consecutive days, transcranial random noise stimulation (tRNS) applied to the parietal region significantly improved attention and increased connectivity in the dorsal and ventral attention network (DVAN).

The improvement in attention was directly correlated with the increased connectivity, suggesting that tRNS could enhance cognitive function in healthy individuals and aid recovery in those with neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention network modulation via tRNS correlates with attention gain. Contò, F., Edwards, G., Tyler, S., et al.[2021]

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The primary objective of this study is to examine the safety, feasibility, and effectiveness of hf-tRNS and 40 Hz tACS interventions targeting left IPL in ...