Noninvasive Brain Stimulation for Lazy Eye

(NIBSAAM Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Midwestern University

Must not be taking: Antipsychotics, Antiepileptics, Opioids

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment High Frequency Transcranial Random Noise Stimulation for Lazy Eye?

Research shows that transcranial random noise stimulation (tRNS) can improve vision in people with amblyopia (lazy eye), specifically enhancing contrast sensitivity and visual acuity in the affected eye. However, these improvements are mostly short-term, with some lasting effects on visual acuity observed after repeated sessions. ^{1 2 3 4 5}

Is transcranial random noise stimulation (tRNS) safe for humans?

Transcranial random noise stimulation (tRNS) is generally considered safe for humans, as it is a non-invasive technique that has been used in various studies to improve brain function without significant adverse effects reported. ^{1 2 6 7 8}

How does the treatment for lazy eye using transcranial random noise stimulation differ from other treatments?

This treatment is unique because it uses non-invasive electrical currents applied to the brain at random frequencies to potentially improve vision by altering brain activity, unlike traditional treatments that might involve eye patches or corrective lenses. ^{1 2 4 6 7}

Research Team

Eligibility Criteria

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.

I am between 18 and 55 years old.

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.

Trial Timeline

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)

Treatment Details

Interventions

• High Frequency Transcranial Random Noise Stimulation (Non-invasive Brain Stimulation)
• Sham Transcranial Random Noise Stimulation (Procedure)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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) 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 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]

References

1. India pubmed.ncbi.nlm.nih.gov

Random noise stimulation in the treatment of patients with neurological disorders. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Electrophysiological evaluation of high and low-frequency transcranial random noise stimulation over the auditory cortex. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Attention network modulation via tRNS correlates with attention gain. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Repetitive visual cortex transcranial random noise stimulation in adults with amblyopia. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of the effects of transcranial random noise stimulation and transcranial direct current stimulation on motor cortical excitability. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. [2022]

8. England 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. [2021]