An interventional study of Anodal-Transcranial Direct Current Stimulation and Office-Based Vergence/Accommodative Therapy in Convergence Insufficiency, sponsored by Midwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Midwestern University · Not applicable, Interventional, and Treatment
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:
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:
Researchers will compare baseline measurements of near point of convergence (NPC) and positive fusional vergence (PFV) to post-treatment measurements for each group.
58 studies on the registry are indexed under Ocular Motility Disorders; 20 are open to participants now.
This study's planned enrollment of 150 is above the median of 91 across 40 interventional studies indexed under Ocular Motility Disorders.
Browse Ocular Motility Disorders studies →Midwestern University is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy.
Device: Anodal-Transcranial Direct Current Stimulation · Behavioral: Office-Based Vergence/Accommodative Therapy
8 sessions of non-invasive brain stimulation only.
Device: Anodal-Transcranial Direct Current Stimulation
8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy.
Behavioral: Office-Based Vergence/Accommodative Therapy · Device: Sham Transcranial Direct Current Stimulation
Non-invasive brain stimulation will involve the use of anodal transcranial direct current stimulation to apply a 2 milliamp current over the left frontal eye field for approximately 20 minutes with a ramp up to the maximum programmed current and ramp down of 20 seconds.
Also known as: tDCS, a-tDCS
Office-based vergence accommodative therapy involves weekly in-office appointments with the therapist lasting approximately 60 minutes per visit during which time in-office procedures will be performed, and home therapy procedures will be demonstrated. Participants will be prescribed 15 minutes of home reinforcement therapy procedures to be completed 5 days per week. Therapy will consist of two phases adapted from the Convergence Insufficiency Treatment Trial (CITT). Therapy procedures will include gross convergence, accommodation. non-computer based vergence, and computer-based vergence.
Also known as: OBVAT, Orthoptic training
Sham transcranial direct current stimulation will be applied over the left frontal eye field with the current ramping up for 20 seconds before ramping down for 20 seconds. The 2 milliamp current stimulation will occur for only a few seconds at the start and at the end of the 20 minutes.
Also known as: Sham tDCS
Near Point of Convergence (NPC)
A change in the NPC break and recovery values measured in centimeters (cm) from baseline after treatment.
Time frame: 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment
Positive Fusional Vergence (PFV)
A change in the near PFV blur, break, and recovery values measured in prism diopters (∆) from baseline after treatment.
Time frame: 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment
Convergence Insufficiency Symptoms Survey (CISS)
A change in the CISS score from baseline after treatment. The minimum score is 0 and the maximum score is 60. Lower scores indicate a better outcome.
Time frame: 8 weeks during treatment; 6 months and 12 months post-treatment
Plan to share: No
Start is estimated for Mar 2025; primary completion for Dec 2028, 45 months later.
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