Back to Trials
NCT05877560NARecruitingAccepts Healthy Volunteers

Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Midwestern University

Start Date

3/1/2025

Completion Date

12/31/2028

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.

Eligibility Criteria

Age Range: 18 years to 40 years

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

Interventions

DEVICE

Anodal-Transcranial Direct Current Stimulation

BEHAVIORAL

Office-Based Vergence/Accommodative Therapy

DEVICE

Sham Transcranial Direct Current Stimulation

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Convergence Insufficiency

Locations

Midwestern University Eye Institute

Downers Grove, Illinois 60515

United States