Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Description

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.

Conditions

Convergence Insufficiency

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Study Overview

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Study Details

Study overview

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.

A Randomized Controlled Study Using Non-invasive Brain Stimulation to Facilitate the Effectiveness of Vergence/Accommodative Therapy in Symptomatic Convergence Insufficiency

Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Condition
Convergence Insufficiency
Intervention / Treatment

-

Contacts and Locations

Downers Grove

Midwestern University Eye Institute, Downers Grove, Illinois, United States, 60515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 40 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Midwestern University,

Study Record Dates

2028-12-31