Noninvasive Brain Stimulation in Adult Amblyopia (NIBSAAM)

Midwestern University

Status: Enrolling

Conditions: Amblyopia

Treatments: Device: High Frequency Transcranial Random Noise Stimulation; Device: Sham Transcranial Random Noise Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06712849

CIRB-IL 23044

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults between 18 and 55 years of age
• Formal diagnosis of amblyopia in one or both eyes of any etiology

Exclusion criteria

• History of optic nerve disease, including glaucoma and optic neuritis
• History of neurological conditions, including demyelinating disease or stroke
• Presence of metal or electronic implants in or on the body, including pacemakers
• Taking medications that can affect normal neurological function, including antipsychotics, antiepileptics, and opioids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Sham Stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Sham Transcranial Random Noise Stimulation

hf-tRNS Stimulation

Active Comparator group

Description:

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

Treatment:

Device: High Frequency Transcranial Random Noise Stimulation