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NCT Number: NCT06712849

Noninvasive Brain Stimulation in Adult Amblyopia

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.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Midwestern University Eye Institute

Downers Grove, Illinois, 60515, United States

Location status: Recruiting

Location contact

Adrienne C Quan, OD

SUB_INVESTIGATOR

Arijit Chakraborty, PhD

PRINCIPAL_INVESTIGATOR

Sherri Olsen

CONTACT

[email protected]

630-515-7368

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham Transcranial Random Noise Stimulation

Device

Sham transcranial random noise stimulation will be applied over the primary visual cortex (area V1) with the current ramping up for 20 seconds before ramping down for 20 seconds. The 2.0 milliamp current stimulation will occur for only a few seconds at the start and at the end of the 40 minutes.

Other names: Sham tRNS

High Frequency Transcranial Random Noise Stimulation

Device

Non-invasive brain stimulation will involve the use of high-frequency transcranial random noise stimulation (100-640 Hz) to apply a 2.0 milliamp current over the primary visual cortex (area V1) for approximately 40 minutes with a ramp up to the maximum programmed current and ramp down of 20 seconds.

Other names: tRNS, hf-tRNS

Primary outcomes

  1. Crowded Visual Acuity

    Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).

    A change in crowded visual acuity is measured in LogMAR from baseline.

  2. Stereo Acuity

    Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).

    A change in stereo acuity is measured in arc seconds from baseline.

  3. Phosphene Threshold

    Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).

    A change in phosphene threshold (%) from baseline.

  4. Global Motion Perception

    Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).

    A change in global motion perception coherence threshold (%) from baseline.

  5. Form Pattern Recognition

    Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).

    A change in form pattern recognition coherence threshold (%) from baseline.

  6. Pattern-reversal Visual Evoked Potentials (pVEP)

    Time frame: Pre-treatment (Day 1); post-treatment (Day 5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).

    A change in N75-P100 amplitudes and P100 latencies from baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Adrienne C Quan, OD

CONTACT

[email protected]

630-960-3183

Arijit Chakraborty, PhD

CONTACT

[email protected]

630-960-3172

Sponsors and collaborators

Lead sponsor

Midwestern University

Other

Registry information

Official study title

Multi-day Effect of Noninvasive Brain Stimulation in Adults With Amblyopia

Acronym: NIBSAAM

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 2, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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