Interventions for Convergence Insufficiency in Children with Concussions

(ICONICC Trial)

Recruiting at 7 trial locations

Overseen By Wendy Woodward

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Mitchell Scheiman

Disqualifiers: Strabismus, Nystagmus, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

264 Participants Needed

Trial Summary

What is the purpose of this trial?

The ICONICC Study is a randomized controlled clinical trial designed to compare the proportion of successful treatment outcomes between children assigned to standard concussion care only, standard concussion care plus simple convergence procedures, or standard concussion care plus office-based vergence/accommodative therapy in children aged 11 to 17 years with symptomatic post-concussion syndrome. Children with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be randomized to a 12-week treatment program of either standard concussion care (SC), SC plus simple convergence procedures (SC+), or SC plus office-based vergence/accommodative therapy SC+OBVAT (1:1:1 ratio). The study will also compare the effect of treatment on clinical measures of both accommodation and vergence, symptom level/burden, health-related quality of life, clinical measures of saccadic eye movement, and objective eye movement measurements of disparity vergence, saccadic function, and accommodative function. The attainment of objective eye movement measures provides an opportunity to understand the underlying neurophysiology of the vergence and accommodative systems. Objective eye movement recordings are powerful because of the rich foundation from primate single-cell recordings that show a direct correlation with vergence and accommodative parameters in the supraoculomotor area of midbrain2, 3 and the oculomotor vermis of the cerebellum.4, 5 Thus, a combined approach of acquiring both clinical vision function measures and objective eye movement recordings in children with PCS-CI may lead to better characterization of the oculomotor phenotype with subsequent improved and personalized therapeutic interventions.

Research Team

Mitchell Scheiman, OD, PhD

Principal Investigator

Salus University

Eligibility Criteria

This trial is for children aged 11 to 17 with post-concussion syndrome (4-12 weeks after injury) who have specific eye movement disorders like convergence insufficiency. They must have good visual acuity, be willing to wear or not wear certain eyewear as required, and cannot have had previous treatments that affect eye movements.

Inclusion Criteria

I am a child aged 11 to 17.

My child and I understand the study and agree to the treatment assignment by chance.

You have a score of 16 or higher on the CI Symptom Survey.

Exclusion Criteria

I have had surgery or Botox for eye alignment or any vision correction surgery.

You have a certain eye alignment issue at a certain distance.

You have a constant eye turn when looking at things up close.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to a 12-week treatment program of either standard concussion care, standard care plus simple convergence procedures, or standard care plus office-based vergence/accommodative therapy.

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)
• SC plus Simple Convergence Exercises (SC+)
• Standard Community Concussion Care (SC)

Trial Overview The ICONICC Study tests if adding simple convergence exercises or office-based therapy to standard concussion care helps kids with symptomatic post-concussion syndrome better than standard care alone. It's a randomized trial where participants are equally divided into three groups for a 12-week treatment program.

Participant Groups

Group I: SC plus Simple Convergence Procedures (SC+) Experimental Treatment 1 Intervention

In addition to the treatment described for SC, participants in this group will be asked to work with the Brock String, which is a popular and simple therapy technique designed to improve convergence. A 3-phase, graded Brock String procedure has been developed for ICONICC.

Group II: SC plus Office-based Vergence/Accommodative Therapy (SC+VAT) Experimental Treatment 1 Intervention

Office-based vergence accommodative therapy (OBVAT) is administered by a study certified therapist at weekly intervals (60-minute office visits with 55 minutes of therapy time), combined with procedures to practice at home for 15 minutes, 5 times per week.

Group III: Standard Community Concussion Care (SC) Active Control 1 Intervention

Standard concussion care consists of physical and cognitive rest immediately following the injury for a brief period of time to allow symptoms to abate, followed by a gradual reintroduction of academic and physical activities, restricting activities at high risk for repeat brain injury (such as contact or collision sports) until a graded return to play protocol has been completed in a symptom-free manner.

Who Is Running the Clinical Trial?

Mitchell Scheiman

Lead Sponsor

Trials

1

Recruited

260+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Marshall B. Ketchum University

Collaborator

Trials

2

Recruited

580+

New Jersey Institute of Technology

Collaborator

Trials

11

Recruited

1,100+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+