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Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency (NIBSCI)

Primary Purpose

Convergence Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anodal-Transcranial Direct Current Stimulation
Office-Based Vergence/Accommodative Therapy
Sham Transcranial Direct Current Stimulation
Sponsored by
Midwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convergence Insufficiency focused on measuring Convergence Insufficiency, Non-invasive Brain Stimulation, Office-Based Vergence/Accommodative Therapy, Frontal Eye Fields, Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • Midwestern University Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

NIBS-OBVAT

NIBS

OBVAT

Arm Description

8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy.

8 sessions of non-invasive brain stimulation only.

8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy.

Outcomes

Primary Outcome Measures

Near Point of Convergence (NPC)
A change in the NPC break and recovery values measured in centimeters (cm) from baseline after treatment.
Positive Fusional Vergence (PFV)
A change in the near PFV blur, break, and recovery values measured in prism diopters (∆) from baseline after treatment.

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2023
Last Updated
October 18, 2023
Sponsor
Midwestern University
Collaborators
Pennsylvania College of Optometry, Southern California College of Optometry at Marshall B. Ketchum University, New Jersey Institute of Technology, University of Waterloo School of Optometry and Vision Science
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1. Study Identification

Unique Protocol Identification Number
NCT05877560
Brief Title
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
Acronym
NIBSCI
Official Title
A Randomized Controlled Study Using Non-invasive Brain Stimulation to Facilitate the Effectiveness of Vergence/Accommodative Therapy in Symptomatic Convergence Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwestern University
Collaborators
Pennsylvania College of Optometry, Southern California College of Optometry at Marshall B. Ketchum University, New Jersey Institute of Technology, University of Waterloo School of Optometry and Vision Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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: Can non-invasive brain stimulation shorten the treatment time of office-based vergence/accommodative therapy for convergence insufficiency? 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: Non-invasive brain stimulation with office-based vergence/accommodative therapy. Sham stimulation with office-based vergence/accommodative therapy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convergence Insufficiency
Keywords
Convergence Insufficiency, Non-invasive Brain Stimulation, Office-Based Vergence/Accommodative Therapy, Frontal Eye Fields, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIBS-OBVAT
Arm Type
Active Comparator
Arm Description
8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy.
Arm Title
NIBS
Arm Type
Active Comparator
Arm Description
8 sessions of non-invasive brain stimulation only.
Arm Title
OBVAT
Arm Type
Sham Comparator
Arm Description
8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy.
Intervention Type
Device
Intervention Name(s)
Anodal-Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS, a-tDCS
Intervention Description
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 30 minutes with a ramp up to the maximum programmed current and ramp down of 10 seconds.
Intervention Type
Behavioral
Intervention Name(s)
Office-Based Vergence/Accommodative Therapy
Other Intervention Name(s)
OBVAT, Orthoptic training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Other Intervention Name(s)
Sham tDCS
Intervention Description
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 30 minutes.
Primary Outcome Measure Information:
Title
Near Point of Convergence (NPC)
Description
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
Title
Positive Fusional Vergence (PFV)
Description
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
Secondary Outcome Measure Information:
Title
Convergence Insufficiency Symptoms Survey (CISS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arijit Chakraborty, PhD
Phone
630-960-3172
Email
achakr@midwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Adrienne C Quan, OD
Phone
630-960-3183
Email
aquan@midwestern.edu
Facility Information:
Facility Name
Midwestern University Eye Institute
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherri Olsen
Phone
630-515-7368
Email
solsen@midwestern.edu
First Name & Middle Initial & Last Name & Degree
Arijit Chakraborty, PhD
First Name & Middle Initial & Last Name & Degree
Adrienne C Quan, OD
First Name & Middle Initial & Last Name & Degree
Clinton R Prestwich, OD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33263359
Citation
Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.
Results Reference
background
PubMed Identifier
33186192
Citation
Alvarez TL, Scheiman M, Santos EM, Yaramothu C, d'Antonio-Bertagnolli JV. Convergence Insufficiency Neuro-mechanism in Adult Population Study Randomized Clinical Trial: Clinical Outcome Results. Optom Vis Sci. 2020 Dec;97(12):1061-1069. doi: 10.1097/OPX.0000000000001606.
Results Reference
background
PubMed Identifier
18852411
Citation
Convergence Insufficiency Treatment Trial Study Group. Randomized clinical trial of treatments for symptomatic convergence insufficiency in children. Arch Ophthalmol. 2008 Oct;126(10):1336-49. doi: 10.1001/archopht.126.10.1336.
Results Reference
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Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

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