NCT06712849

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. 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. 2.Do cumulative sessions of non-invasive brain stimulation influence neural plasticity and higher-order visual functions in adults with amblyopia?
  3. 3.High-frequency transcranial random noise stimulation (hf-tRNS).
  4. 4.Sham stimulation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
32mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
May 2024Dec 2028

Study Start

First participant enrolled

May 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

3.7 years

First QC Date

November 27, 2024

Last Update Submit

December 9, 2024

Conditions

Amblyopia

Keywords

AmblyopiaNon-invasive Brain StimulationTranscranial Random Noise StimulationVisual PerceptionVisual Evoked Potentials

Outcome Measures

Primary Outcomes (6)

  • Crowded Visual Acuity

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

    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

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

    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

    A change in phosphene threshold (%) from baseline.

    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

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

    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

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

    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)

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

    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).

Study Arms (2)

Sham Stimulation

SHAM COMPARATOR

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

Device: Sham Transcranial Random Noise Stimulation

hf-tRNS Stimulation

ACTIVE COMPARATOR

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

Device: High Frequency Transcranial Random Noise Stimulation

Interventions

Sham Transcranial Random Noise StimulationDEVICE

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.

Also known as: Sham tRNS
Sham Stimulation
High Frequency Transcranial Random Noise StimulationDEVICE

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.

Also known as: tRNS, hf-tRNS
hf-tRNS Stimulation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwestern University Eye Institute

Downers Grove, Illinois, 60515, United States

RECRUITING

Related Publications (4)

  • Ding Z, Li J, Spiegel DP, Chen Z, Chan L, Luo G, Yuan J, Deng D, Yu M, Thompson B. The effect of transcranial direct current stimulation on contrast sensitivity and visual evoked potential amplitude in adults with amblyopia. Sci Rep. 2016 Jan 14;6:19280. doi: 10.1038/srep19280.

    PMID: 26763954BACKGROUND

  • Thompson B, Mansouri B, Koski L, Hess RF. Brain plasticity in the adult: modulation of function in amblyopia with rTMS. Curr Biol. 2008 Jul 22;18(14):1067-71. doi: 10.1016/j.cub.2008.06.052.

    PMID: 18635353BACKGROUND

  • Thompson B, Mansouri B, Koski L, Hess RF. From motor cortex to visual cortex: the application of noninvasive brain stimulation to amblyopia. Dev Psychobiol. 2012 Apr;54(3):263-73. doi: 10.1002/dev.20509. Epub 2010 Nov 8.

    PMID: 22415915BACKGROUND

  • Clavagnier S, Thompson B, Hess RF. Long lasting effects of daily theta burst rTMS sessions in the human amblyopic cortex. Brain Stimul. 2013 Nov;6(6):860-7. doi: 10.1016/j.brs.2013.04.002. Epub 2013 Apr 28.

    PMID: 23664756BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Arijit Chakraborty, PhD

CONTACT

630-960-3172achakr@midwestern.edu

Adrienne C Quan, OD

CONTACT

630-960-3183aquan@midwestern.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director of Research

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 2, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)