Recruiting

Noninvasive Brain Stimulation

Sponsor:

Midwestern University

Code:

NCT06712849

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Sham Transcranial Random Noise Stimulation

High Frequency Transcranial Random Noise Stimulation

Study Details

Brief 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.

Conditions

Amblyopia

Study ID

NCT06712849

Start date

May 1, 2024

Status verified date

Dec, 2024

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Sham Transcranial Random Noise Stimulation

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

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.

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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • 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). ]

Central Contacts and Locations

Central contacts

Arijit Chakraborty, PhD

630-960-3172achakr@midwestern.edu

Adrienne C Quan, OD

630-960-3183aquan@midwestern.edu

Locations

Midwestern University Eye Institute

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Sherri Olsen

630-515-7368solsen@midwestern.edu

Principal Investigator:

Arijit Chakraborty, PhD

More Information

Sponsor

Midwestern University

Last update posted

Dec 12, 2024

Last verified

Dec, 2024

Keywords

  • Amblyopia
  • Non-invasive Brain Stimulation
  • Transcranial Random Noise Stimulation
  • Visual Perception
  • Visual Evoked Potentials

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Midwestern University on 2024-12-12.