Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Conditions

• Convergence Insufficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - 40 Years

Healthy Volunteers

Accepted

Interventions

• Anodal-Transcranial Direct Current Stimulation — DEVICE
  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.
• Office-Based Vergence/Accommodative Therapy — BEHAVIORAL
  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.
• Sham Transcranial Direct Current Stimulation — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Mar 1, 2025

Status verified

Nov 2024

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Near Point of Convergence (NPC) [ Time Frame: 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment ]

Central Contacts

• Arijit Chakraborty, PhD
  630-960-3172
  [email protected]
• Adrienne C Quan, OD
  630-960-3183
  [email protected]

Locations (1)

Find similar trials in Downers Grove, IL

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