Convergence InsufficiencyNIBSCINCT05877560
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
A study testing Anodal-Transcranial Direct Current Stimulation and Office-Based Vergence/Accommodative Therapy in people with Convergence Insufficiency, run by Midwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Convergence Insufficiency
- What is being tested?
- Anodal-Transcranial Direct Current Stimulation and Office-Based Vergence/Accommodative Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Midwestern University Eye Institute
Downers Grove, Illinois, 60515
Sherri Olsen, 1-630-515-7368, solsen@midwestern.edu
Arijit Chakraborty, PhD
About this study
Official title: A Randomized Controlled Study Using Non-invasive Brain Stimulation to Facilitate the Effectiveness of Vergence/Accommodative Therapy in Symptomatic Convergence Insufficiency
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?
Read more
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.
- Conditions
- Convergence Insufficiency
- Being tested
- Anodal-Transcranial Direct Current Stimulation, Office-Based Vergence/Accommodative Therapy, Sham Transcranial Direct Current Stimulation
- Keywords
- Convergence Insufficiency, Non-invasive Brain Stimulation, Office-Based Vergence/Accommodative Therapy, Frontal Eye Fields, Transcranial Direct Current Stimulation
- Medical subject headings
- Ocular Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal-Transcranial Direct Current StimulationDevice
Also called tDCS, a-tDCS
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 TherapyBehavioural
Also called OBVAT, Orthoptic training
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 StimulationDevice
Also called Sham tDCS
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 group | Role | What they receive |
|---|---|---|
| NIBS-OBVAT | Active comparator | 8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy. Receives: Device: Anodal-Transcranial Direct Current Stimulation; Behavioral: Office-Based Vergence/Accommodative Therapy |
| NIBS | Active comparator | 8 sessions of non-invasive brain stimulation only. Receives: Device: Anodal-Transcranial Direct Current Stimulation |
| OBVAT | Sham comparator | 8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy. Receives: Behavioral: Office-Based Vergence/Accommodative Therapy; Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Point of Convergence (NPC)
A change in the NPC break and recovery values measured in centimeters (cm) from baseline after treatment.
Measured: 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.
Measured: 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment
Secondary outcomes (1)
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.
Measured: 8 weeks during treatment; 6 months and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Convergence InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arijit Chakraborty, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877560
- Sponsor's protocol ID
- CIRB-IL 22013
- Acronym
- NIBSCI
- Status last verified
- Nov 2024
- First submitted
- 17 May 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33263359Alvarez 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.
PubMed 33186192Convergence 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.
PubMed 18852411
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Using Non-invasive Brain Stimulation to Facilitate the Effectiveness of Vergence/Accommodative Therapy in Symptomatic Convergence Insufficiency
- ClinicalTrials.gov ID
- NCT05877560
- Acronym / sponsor ID
- NIBSCI / CIRB-IL 22013
- Conditions
- Convergence Insufficiency
- Keywords
- Convergence Insufficiency, Non-invasive Brain Stimulation, Office-Based Vergence/Accommodative Therapy, Frontal Eye Fields, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NIBS-OBVAT | Active comparator | Device: Anodal-Transcranial Direct Current Stimulation, Behavioral: Office-Based Vergence/Accommodative Therapy8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy. |
| NIBS | Active comparator | Device: Anodal-Transcranial Direct Current Stimulation8 sessions of non-invasive brain stimulation only. |
| OBVAT | Sham comparator | Behavioral: Office-Based Vergence/Accommodative Therapy, Device: Sham Transcranial Direct Current Stimulation8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal-Transcranial Direct Current StimulationAlso: tDCS, a-tDCSNon-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. | Device | NIBS, NIBS-OBVAT |
| Office-Based Vergence/Accommodative TherapyAlso: OBVAT, Orthoptic trainingOffice-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. | Behavioural | NIBS-OBVAT, OBVAT |
| Sham Transcranial Direct Current StimulationAlso: Sham tDCSSham 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. | Device | OBVAT |
Primary outcome
Near Point of Convergence (NPC)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Convergence Insufficiency Symptoms Survey (CISS)
Time frame: 8 weeks during treatment; 6 months and 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Background: PubMed 33263359Scheiman 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.
- Background: PubMed 33186192Alvarez 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.
- Background: PubMed 18852411Convergence 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal-Transcranial Direct Current Stimulation and Office-Based Vergence/Accommodative Therapy in people with Convergence Insufficiency, run by Midwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arijit Chakraborty, PhD (630-960-3172, achakr@midwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877560, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.