Noninvasive Brain Stimulation for Lazy Eye (NIBSAAM Trial)
Palo Alto (17 mi)Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Midwestern University
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.
Do I have to stop taking my current medications for the trial?Yes, you must stop taking medications that can affect normal neurological function, such as antipsychotics, antiepileptics, and opioids, to participate in the trial.
Is High Frequency Transcranial Random Noise Stimulation a promising treatment for Lazy Eye?Yes, High Frequency Transcranial Random Noise Stimulation (hf-tRNS) is a promising treatment. It can enhance brain function and improve cognitive and sensory abilities. Studies show it can boost attention and cognitive capacity, which might help in treating conditions like Lazy Eye.12568
What safety data exists for noninvasive brain stimulation for lazy eye?The safety data for transcranial random noise stimulation (tRNS), including high-frequency tRNS (hf-tRNS), is still being explored. Studies have shown that tRNS can increase cortical excitability and improve cognitive and motor performance. A randomized, double-blind, sham-controlled pilot study on hf-tRNS for schizophrenia reported a high completion rate (97.2%) and significant improvements in symptoms, suggesting a favorable safety profile. However, more randomized controlled trials and physiological studies are needed to fully understand the safety and optimal delivery methods of tRNS.12358
What data supports the idea that Noninvasive Brain Stimulation for Lazy Eye is an effective treatment?The available research shows that Noninvasive Brain Stimulation, specifically transcranial random noise stimulation (tRNS), can improve vision in people with a lazy eye. In a study, adults with a lazy eye who received this treatment showed significant improvements in their ability to see contrasts and in their visual clarity when looking at single objects. These improvements were noticeable right after the treatment and lasted for at least 28 days for visual clarity. However, the treatment did not lead to long-lasting improvements in seeing contrasts or when looking at crowded objects. Compared to a placebo treatment, which showed no effects, tRNS appears to be effective in enhancing certain aspects of vision in people with a lazy eye.45678
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 have a history of optic nerve disease, such as glaucoma.
I have a history of neurological conditions like multiple sclerosis or stroke.
Treatment Details
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.
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
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
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.
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.
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.
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.
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.