RECRUITING

Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-01
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05877560

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.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Best-corrected visual acuity of \> 20/25 in each eye at distance and near
  2. * Exophoria at near at least 4∆ greater than at far
  3. * Receded near point of convergence of \> 6 cm break
  4. * Insufficient positive fusional vergence at near (\< 15∆ base-out blur or break)
  5. * CISS score of 16 and greater for children or 21 and greater for adults
  6. * Have had a dilated fundus examination within the last 12 months
  7. * Informed consent and willingness to participate in the study and be randomized
  1. * Previously treated for convergence insufficiency with home- or office-based vergence/accommodative therapy
  2. * Amblyopia (\> 2-line difference in best-corrected visual acuity between the two eyes)
  3. * Constant strabismus
  4. * History of strabismus surgery
  5. * Convergence insufficiency secondary to acquired brain injury or neurological disorder
  6. * Manifest or latent nystagmus
  7. * Systemic disease known to affect accommodation, vergence, and ocular motility including multiple sclerosis, Graves disease, myasthenia gravis, Parkinson's disease, cerebral palsy, and diabetes
  8. * Developmental disability, attention deficit hyperactivity disorder (ADHD), learning disability or cognitive dysfunction that would interfere with treatment
  9. * Taking medications that can affect normal neurological function including antipsychotics, antiepileptics, and opioids
  10. * Presence of metal or electronic implants in or on the body, including pacemakers

Contacts and Locations

Study Contact

Arijit Chakraborty, PhD
CONTACT
630-960-3172
achakr@midwestern.edu
Adrienne C Quan, OD
CONTACT
630-960-3183
aquan@midwestern.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Midwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Convergence Insufficiency
  • Non-invasive Brain Stimulation
  • Office-Based Vergence/Accommodative Therapy
  • Frontal Eye Fields
  • Transcranial Direct Current Stimulation

Additional Relevant MeSH Terms

  • Convergence Insufficiency