Noninvasive Brain Stimulation in Adult Amblyopia

Last updated: December 9, 2024
Sponsor: Midwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disease

Eye Disorders/infections

Vision Loss

Treatment

High Frequency Transcranial Random Noise Stimulation

Sham Transcranial Random Noise Stimulation

Clinical Study ID

NCT06712849
CIRB-IL 23044
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults between 18 and 55 years of age

  • Formal diagnosis of amblyopia in one or both eyes of any etiology

Exclusion

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, includingantipsychotics, antiepileptics, and opioids

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: High Frequency Transcranial Random Noise Stimulation
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Midwestern University Eye Institute

    Downers Grove, Illinois 60515
    United States

    Active - Recruiting

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