Brain Stimulation for Convergence Insufficiency
(NIBSCI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that participants not take medications that can affect normal neurological function, such as antipsychotics, antiepileptics, and opioids. If you are taking these medications, you may need to stop them to participate.
How is Office-Based Vergence/Accommodative Therapy different from other treatments for convergence insufficiency?
Office-Based Vergence/Accommodative Therapy is unique because it involves specific exercises to improve eye coordination and focus, and it has been shown to change brain activity related to vision, which is not typically addressed by other treatments. It is effective in about 75% of patients, making it a reliable option for those with convergence insufficiency.12345
What data supports the effectiveness of this treatment for convergence insufficiency?
Are You a Good Fit for This Trial?
Adults with symptomatic convergence insufficiency, specifically those who have a receded near point of convergence, insufficient positive fusional vergence at near, and a certain score on the CISS test. Participants must not have had previous treatments for this condition, no history of constant strabismus or surgery for it, and should not be affected by systemic diseases that impact eye function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive non-invasive brain stimulation and/or office-based vergence/accommodative therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anodal-Transcranial Direct Current Stimulation
- Office-Based Vergence/Accommodative Therapy
- Sham Transcranial Direct Current Stimulation
Office-Based Vergence/Accommodative Therapy is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Midwestern University
Lead Sponsor
New Jersey Institute of Technology
Collaborator
University of Waterloo School of Optometry and Vision Science
Collaborator
Pennsylvania College of Optometry
Industry Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Collaborator