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.12345
Is transcranial random noise stimulation (tRNS) safe for humans?
How does the treatment for lazy eye using transcranial random noise stimulation differ from other treatments?
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.
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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 OverviewThe 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
2Treatment groups
Active Control
Placebo Group
Group I: hf-tRNS StimulationActive Control1 Intervention
40-minute sessions of hf-tRNS stimulation for 5 consecutive days.
Group II: Sham StimulationPlacebo Group1 Intervention
40-minute sessions of sham stimulation for 5 consecutive days.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Midwestern University Eye InstituteDowners Grove, IL
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Who Is Running the Clinical Trial?
Midwestern UniversityLead Sponsor
References
Random noise stimulation in the treatment of patients with neurological disorders. [2022]Random noise stimulation technique involves applying any form of energy (for instance, light, mechanical, electrical, sound) with unpredictable intensities through time to the brain or sensory receptors to enhance sensory, motor, or cognitive functions. Random noise stimulation initially employed mechanical noise in auditory and cutaneous stimuli, but electrical energies applied to the brain or the skin are becoming more frequent, with a series of clinical applications. Indeed, recent evidence shows that transcranial random noise stimulation can increase corticospinal excitability, improve cognitive/motor performance, and produce beneficial aftereffects at the behavioral and psychological levels. Here, we present a narrative review about the potential uses of random noise stimulation to treat neurological disorders, including attention deficit hyperactivity disorder, schizophrenia, amblyopia, myopia, tinnitus, multiple sclerosis, post-stroke, vestibular-postural disorders, and sensitivity loss. Many of the reviewed studies reveal that the optimal way to deliver random noise stimulation-based therapies is with the concomitant use of neurological and neuropsychological assessments to validate the beneficial aftereffects. In addition, we highlight the requirement of more randomized controlled trials and more physiological studies of random noise stimulation to discover another optimal way to perform the random noise stimulation interventions.
Electrophysiological evaluation of high and low-frequency transcranial random noise stimulation over the auditory cortex. [2021]Transcranial random noise stimulation (tRNS) is a non-invasive brain stimulation technique which uses electrical alternating currents applied at random frequencies. Besides the ability to alter cortical excitability, past research demonstrated that high-frequency tRNS over the auditory cortex can modulate both spontaneous and auditory evoked oscillatory brain activity.
Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. [2022]Van der Groen, O., Potok, W., Wenderoth, N., Edwards, G., Mattingley, J.B. and Edwards, D. Using noise for the better: The effects of transcranial random noise stimulation on the brain and behavior. NEUROSCI BIOBEHAV REV X (X) XXX-XXX 2021.- Transcranial random noise stimulation (tRNS) is a non-invasive electrical brain stimulation method that is increasingly employed in studies of human brain function and behavior, in health and disease. tRNS is effective in modulating perception acutely and can improve learning. By contrast, its effectiveness for modulating higher cognitive processes is variable. Prolonged stimulation with tRNS, either as one longer application, or multiple shorter applications, may engage plasticity mechanisms that can result in long-term benefits. Here we provide an overview of the current understanding of the effects of tRNS on the brain and behavior and provide some specific recommendations for future research.
Attention network modulation via tRNS correlates with attention gain. [2021]Transcranial random noise stimulation (tRNS) can enhance vision in the healthy and diseased brain. Yet, the impact of multi-day tRNS on large-scale cortical networks is still unknown. We investigated the impact of tRNS coupled with behavioral training on resting-state functional connectivity and attention. We trained human subjects for 4 consecutive days on two attention tasks, while receiving tRNS over the intraparietal sulci, the middle temporal areas, or Sham stimulation. We measured resting-state functional connectivity of nodes of the dorsal and ventral attention network (DVAN) before and after training. We found a strong behavioral improvement and increased connectivity within the DVAN after parietal stimulation only. Crucially, behavioral improvement positively correlated with connectivity measures. We conclude changes in connectivity are a marker for the enduring effect of tRNS upon behavior. Our results suggest that tRNS has strong potential to augment cognitive capacity in healthy individuals and promote recovery in the neurological population.
Repetitive visual cortex transcranial random noise stimulation in adults with amblyopia. [2021]We tested the hypothesis that five daily sessions of visual cortex transcranial random noise stimulation would improve contrast sensitivity, crowded and uncrowded visual acuity in adults with amblyopia. Nineteen adults with amblyopia (44.2 ± 14.9 years, 10 female) were randomly allocated to active or sham tRNS of the visual cortex (active, n = 9; sham, n = 10). Sixteen participants completed the study (n = 8 per group). tRNS was delivered for 25 min across five consecutive days. Monocular contrast sensitivity, uncrowded and crowded visual acuity were measured before, during, 5 min and 30 min post stimulation on each day. Active tRNS significantly improved contrast sensitivity and uncrowded visual acuity for both amblyopic and fellow eyes whereas sham stimulation had no effect. An analysis of the day by day effects revealed large within session improvements on day 1 for the active group that waned across subsequent days. No long-lasting (multi-day) improvements were observed for contrast sensitivity, however a long-lasting improvement in amblyopic eye uncrowded visual acuity was observed for the active group. This improvement remained at 28 day follow up. However, between-group differences in baseline uncrowded visual acuity complicate the interpretation of this effect. No effect of tRNS was observed for amblyopic eye crowded visual acuity. In agreement with previous non-invasive brain stimulation studies using different techniques, tRNS induced short-term contrast sensitivity improvements in adult amblyopic eyes, however, repeated sessions of tRNS did not lead to enhanced or long-lasting effects for the majority of outcome measures.
Comparison of the effects of transcranial random noise stimulation and transcranial direct current stimulation on motor cortical excitability. [2015]The objective of this study was to examine the effect of transcranial random noise stimulation (tRNS) with and without a direct current (DC) offset on motor cortical excitability and compare results to transcranial DC stimulation (tDCS).
Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. [2022]Transcranial random noise stimulation (tRNS) is an innovative technique of non-invasive electrical stimulation. tRNS over the parietal cortex has improved cognitive function in healthy controls and, applied to the auditory cortex, tRNS has shown beneficial effects on tinnitus.
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]High-frequency transcranial random noise stimulation (hf-tRNS) is a non-invasive neuromodulatory technique capable of increasing human cortex excitability. There were only published case reports on the use of hf-tRNS targeting the lateral prefrontal cortex in treating negative symptoms of schizophrenia, thus necessitating systematic investigation. We designed a randomized, double-blind, sham-controlled trial in a cohort of stabilized schizophrenia patients to examine the efficacy of add-on hf-tRNS (100-640 Hz; 2 mA; 20 min) using a high definition 4 × 1 electrode montage (anode AF3, cathodes AF4, F2, F6, and FC4) in treating negative symptoms (ClinicalTrials.gov ID: NCT04038788). Participants received either active hf-tRNS or sham twice daily for 5 consecutive weekdays. Primary outcome measure was the change over time in the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS), which was measured at baseline, after 10-session stimulation, and at one-week and one-month follow-ups. Among 36 randomized patients, 35 (97.2%) completed the trial. Intention-to-treat analysis showed a significantly greater decrease in PANSS-FSNS score after active (-17.11%) than after sham stimulation (-1.68%), with a large effect size (Cohen's d = 2.16, p