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Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Midwestern University · NCT05877560

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–40 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
150
US sites recruiting
1
Study start
March 1, 2025
Record last updated
December 2, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • Can non-invasive brain stimulation shorten the treatment time of office-based vergence/accommodative therapy for convergence insufficiency?
  • 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:

  • Non-invasive brain stimulation with office-based vergence/accommodative therapy.
  • Sham stimulation with office-based vergence/accommodative therapy.
  • 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.

Being studied: Anodal-Transcranial Direct Current Stimulation; Office-Based Vergence/Accommodative Therapy; Sham Transcranial Direct Current Stimulation

Conditions: Convergence Insufficiency

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Midwestern University Eye Institute

    Downers Grove, IL 60515

    Site contact: Sherri Olsen · 1-630-515-7368 · solsen@midwestern.edu

Study contacts (from the official record)

  • Arijit Chakraborty, PhD · 630-960-3172 · achakr@midwestern.edu
  • Adrienne C Quan, OD · 630-960-3183 · aquan@midwestern.edu
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Non-invasive Brain Stimulation for Treating Symptomatic… (NCT05877560) | Bored Studies