RecruitingNot Applicable

Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

United States150 participantsStarted 2025-03-01

Plain-language summary

The goal of this randomized controlled trial is to test the effectiveness of non-invasive brain stimulation in treating adults with symptomatic convergence insufficiency compared to vergence/accommodative therapy. The main questions it aims to answer are: 1. Can non-invasive brain stimulation shorten the treatment time of office-based vergence/accommodative therapy for convergence insufficiency? 2. Is non-invasive brain stimulation alone just as effective as office-based vergence/accommodative therapy in treating convergence insufficiency? The investigators hypothesize that non-invasive brain stimulation will shorten the treatment time from 12 weeks to 8 weeks of office-based vergence/accommodative therapy and that non-invasive brain stimulation alone would be equally effective as office-based vergence/accommodative therapy in improving symptomatic convergence insufficiency. Participants will be randomized into one of three treatment groups: 1. Non-invasive brain stimulation with office-based vergence/accommodative therapy. 2. Sham stimulation with office-based vergence/accommodative therapy. 3. Non-invasive brain stimulation only. Researchers will compare baseline measurements of near point of convergence (NPC) and positive fusional vergence (PFV) to post-treatment measurements for each group.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Best-corrected visual acuity of \> 20/25 in each eye at distance and near * Exophoria at near at least 4∆ greater than at far * Receded near point of convergence of \> 6 cm break * Insufficient positive fusional vergence at near (\< 15∆ base-out blur or break) * CISS score of 16 and greater for children or 21 and greater for adults * Have had a dilated fundus examination within the last 12 months * Informed consent and willingness to participate in the study and be randomized Exclusion Criteria: * Previously treated for convergence insufficiency with home- or office-based vergence/accommodative therapy * Amblyopia (\> 2-line difference in best-corrected visual acuity between the two eyes) * Constant strabismus * History of strabismus surgery * Convergence insufficiency secondary to acquired brain injury or neurological disorder * Manifest or latent nystagmus * Systemic disease known to affect accommodation, vergence, and ocular motility including multiple sclerosis, Graves disease, myasthenia gravis, Parkinson's disease, cerebral palsy, and diabetes * Developmental disability, attention deficit hyperactivity disorder (ADHD), learning disability or cognitive dysfunction that would interfere with treatment * Taking medications that can affect normal neurological function including antipsychotics, antiepileptics, and opioids * Presence of metal or electronic implants in or on the body, including pacemakers

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Near Point of Convergence (NPC)

Timeframe: 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment

Positive Fusional Vergence (PFV)

Timeframe: 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment

Trial details

NCT IDNCT05877560

SponsorMidwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Arijit Chakraborty, PhD

630-960-3172 achakr@midwestern.edu

View on ClinicalTrials.gov More Convergence Insufficiency trials