Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Last updated: November 27, 2024
Sponsor: Midwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Anodal-Transcranial Direct Current Stimulation

Office-Based Vergence/Accommodative Therapy

Sham Transcranial Direct Current Stimulation

Clinical Study ID

NCT05877560
CIRB-IL 22013
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Previously treated for convergence insufficiency with home- or office-basedvergence/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 neurologicaldisorder

  • Manifest or latent nystagmus

  • Systemic disease known to affect accommodation, vergence, and ocular motilityincluding multiple sclerosis, Graves disease, myasthenia gravis, Parkinson'sdisease, cerebral palsy, and diabetes

  • Developmental disability, attention deficit hyperactivity disorder (ADHD), learningdisability or cognitive dysfunction that would interfere with treatment

  • Taking medications that can affect normal neurological function includingantipsychotics, antiepileptics, and opioids

  • Presence of metal or electronic implants in or on the body, including pacemakers

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Anodal-Transcranial Direct Current Stimulation
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Midwestern University Eye Institute

    Downers Grove, Illinois 60515
    United States

    Active - Recruiting

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