Non-invasive brain stimulation for treating convergence insufficiency
A Randomized Controlled Study Using Non-invasive Brain Stimulation to Facilitate the Effectiveness of Vergence/Accommodative Therapy in Symptomatic Convergence Insufficiency
This study is testing if a new type of brain stimulation can help adults with convergence insufficiency feel better in less time than traditional therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Midwestern University Academic / other |
| Locations | 1 site (Downers Grove, Illinois) |
| Trial ID | NCT05877560 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of non-invasive brain stimulation in adults with symptomatic convergence insufficiency. Participants will be randomized into three groups: one receiving non-invasive brain stimulation, another undergoing office-based vergence/accommodative therapy, and a third receiving sham stimulation. The study seeks to determine if non-invasive brain stimulation can reduce the treatment duration from 12 weeks to 8 weeks and if it is as effective as traditional therapy in alleviating symptoms. The trial will measure improvements in visual function and symptom relief.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic convergence insufficiency who meet specific visual acuity and vergence criteria.
Not a fit: Patients with a history of strabismus surgery, amblyopia, or convergence insufficiency due to neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a faster and equally effective treatment option for patients with convergence insufficiency.
How similar studies have performed: While the use of non-invasive brain stimulation is a novel approach in this context, similar studies have shown promise in other areas of visual and neurological rehabilitation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Downers Grove, Illinois
- Midwestern University Eye Institute — Downers Grove, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Arijit Chakraborty, PhD
- Email: achakr@midwestern.edu
- Phone: 630-960-3172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.