Noninvasive Brain Stimulation in Adult Amblyopia

Part of paid clinical trials in Downers Grove, Illinois.

Sponsor
Midwestern University
Study ID
NCT06712849
Status
Recruiting
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Conditions

  • Amblyopia

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham Stimulation
    40-minute sessions of sham stimulation for 5 consecutive days.
  • Active Comparator: hf-tRNS Stimulation
    40-minute sessions of hf-tRNS stimulation for 5 consecutive days.

Primary Outcome Measure

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Midwestern University Eye InstituteDowners GroveIllinois60515
Sherri Olsen
[email protected]
630-515-7368
Arijit Chakraborty, PhD (PRINCIPAL_INVESTIGATOR)
Adrienne C Quan, OD (SUB_INVESTIGATOR)

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By research site
Midwestern University Eye Institute· Downers Grove, IL

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