Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Convergence Insufficiency
In brief
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.
Key facts
- Study ID
- NCT05877560
- Run by
- Midwestern University
- People needed
- 150
- Starts
- 2025-03-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2024-12-02
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Midwestern University Eye Institute — Downers Grove, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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