Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

NCT05877560 | Recruiting FDA Device

• 1 other identifier: CIRB-IL 22013
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.Can non-invasive brain stimulation shorten the treatment time of office-based vergence/accommodative therapy for convergence insufficiency?
2. 2.Is non-invasive brain stimulation alone just as effective as office-based vergence/accommodative therapy in treating convergence insufficiency?
3. 3.Non-invasive brain stimulation with office-based vergence/accommodative therapy.
4. 4.Sham stimulation with office-based vergence/accommodative therapy.
5. 5.Non-invasive brain stimulation only.

Conditions

Convergence Insufficiency

Keywords

Convergence Insufficiency; Non-invasive Brain Stimulation; Office-Based Vergence/Accommodative Therapy; Frontal Eye Fields; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (2)

• Near Point of Convergence (NPC)

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

  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.

  4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment

Secondary Outcomes (1)

• Convergence Insufficiency Symptoms Survey (CISS)

  8 weeks during treatment; 6 months and 12 months post-treatment

Study Arms (3)

NIBS-OBVAT

ACTIVE COMPARATOR

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

NIBS

ACTIVE COMPARATOR

8 sessions of non-invasive brain stimulation only.

Device: Anodal-Transcranial Direct Current Stimulation

OBVAT

SHAM COMPARATOR

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

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.

Also known as: tDCS, a-tDCS

NIBS; NIBS-OBVAT

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.

Also known as: OBVAT, Orthoptic training

NIBS-OBVAT; OBVAT

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.

Also known as: Sham tDCS

OBVAT

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwestern University: lead

Study Sites (1)

Midwestern University Eye Institute

Downers Grove, Illinois, 60515, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 8092638 BACKGROUND

• 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.

  PMID: 7744390 BACKGROUND

• 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.

  PMID: 2779032 BACKGROUND

MeSH Terms

Conditions

Ocular Motility Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Arijit Chakraborty, PhD

CONTACT

630-960-3172; achakr@midwestern.edu

Adrienne C Quan, OD

CONTACT

630-960-3183; aquan@midwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director of Research

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)