Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
NCT ID: NCT05877560
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-03-01
2028-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NIBS-OBVAT
8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy.
Anodal-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.
Office-Based Vergence/Accommodative Therapy
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.
NIBS
8 sessions of non-invasive brain stimulation only.
Anodal-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.
OBVAT
8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy.
Office-Based Vergence/Accommodative Therapy
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
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.
Interventions
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Anodal-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.
Office-Based Vergence/Accommodative Therapy
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Midwestern University
OTHER
Responsible Party
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Arijit Chakraborty
Assistant Director of Research
Locations
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Midwestern University Eye Institute
Downers Grove, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Arijit Chakraborty, PhD
Role: backup
Adrienne C Quan, OD
Role: backup
Clinton R Prestwich, OD
Role: backup
References
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Duval JL, Jaubert D, Poizot-Martin I, De Jaureguiberry JP, Lafeuillade A, Giovannini M, Carloz E, Dhiver C, Gastaut JA. [Colonic leishmaniasis in AIDS]. Ann Med Interne (Paris). 1994;145(3):198-9. No abstract available. French.
Xie Y, Wan B, Li W. [Effect of bee pollen on maternal nutrition and fetal growth]. Hua Xi Yi Ke Da Xue Xue Bao. 1994 Dec;25(4):434-7. Chinese.
Nakano H, Ida T, Harada A, Horiba K, Sakakibara T, Kawase M, Tatsuno K, Obunai Y, Murata M. [Application of epicardial approach technique to the anterior-paraseptal type Wolff-Parkinson-White syndrome]. Kyobu Geka. 1989 May;42(5):358-62. Japanese.
Other Identifiers
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CIRB-IL 22013
Identifier Type: -
Identifier Source: org_study_id