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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
United States
Illinois
Midwestern University Eye Institute
RECRUITING
Downers Grove
Contact Information
Primary
Arijit Chakraborty, PhD
achakr@midwestern.edu
630-960-3172
Backup
Adrienne C Quan, OD
aquan@midwestern.edu
630-960-3183
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 150
Treatments
Active_comparator: NIBS-OBVAT
8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy.
Active_comparator: NIBS
8 sessions of non-invasive brain stimulation only.
Sham_comparator: OBVAT
8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy.
Related Therapeutic Areas
Sponsors
Leads: Midwestern University

This content was sourced from clinicaltrials.gov