Non-invasive Brain Stimulation for Convergence Insufficiency

This study is looking at new ways to treat Convergence Insufficiency, a condition where your eyes have trouble working together when looking at close objects. Researchers are testing if a non-invasive brain stimulation called Anodal-Transcranial Direct Current Stimulation can help adults aged 18-40 with this condition. They want to see if it can shorten the treatment time of traditional eye exercises (Office-Based Vergence/Accommodative Therapy) or be just as effective on its own. The study aims to enroll 150 participants and will measure improvements in your near vision (Near Point of Convergence and Positive Fusional Vergence) over several months.

Study design
This is a randomized controlled trial planning to enroll 150 participants. It compares different treatments for Convergence Insufficiency.
What's involved
You would have weekly in-office appointments for about 60 minutes for eye therapy. Brain stimulation treatments last about 20 minutes.
Compensation
Not stated in the trial record.
Follow-up
Your vision will be checked at 4, 6, and 8 weeks during treatment, and then again 6 and 12 months after treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05877560

Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Recruiting
NAAges 18–40InterventionalTreatment
Midwestern University
~150 participants
Updated 2024-12-02 on ClinicalTrials.gov
What's tested:Anodal-Transcranial Direct Current StimulationOffice-Based Vergence/Accommodative TherapySham Transcranial Direct Current Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Near Point of Convergence (NPC)
Measured over 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment
+1 more outcome measured
Convergence Insufficiency
1 sites across 1 states
Illinois1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Near Point of Convergence (NPC)4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment

    A change in the NPC break and recovery values measured in centimeters (cm) from baseline after treatment.

  • Positive Fusional Vergence (PFV)4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment

    A change in the near PFV blur, break, and recovery values measured in prism diopters (∆) from baseline after treatment.