Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Launched by MIDWESTERN UNIVERSITY · May 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for adults with a condition called convergence insufficiency, which makes it difficult to focus on nearby objects. The researchers want to find out if a method called non-invasive brain stimulation can help improve treatment outcomes. Specifically, they are looking at whether this brain stimulation can reduce the amount of time needed for traditional therapy or if it can work just as well on its own. Participants in the trial will be randomly assigned to one of three groups: one receiving the brain stimulation along with therapy, another receiving a fake stimulation with therapy, and a third receiving only the brain stimulation.

To be eligible for the trial, participants should have good vision and specific symptoms related to convergence insufficiency. They need to be willing to undergo random assignment and have had a recent eye exam. Throughout the study, participants will have their eye measurements taken before and after treatment to see how well each method works. If you're considering participating, it's important to know that certain medical conditions and medications may exclude you from the study, as well as any previous treatments for this eye condition.

Gender

ALL

Eligibility 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