Interventions for Convergence Insufficiency in Concussed Children

Summary

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.

Conditions

• Concussion
• Convergence Insufficiency

Interventions

BEHAVIORAL

Standard Community Concussion Care (SC)

temporary rest, gradual increase in activity, and return to school and sports. In some cases vestibular an balance therapy are necessary, aerobic exercises, medication, counseling.

BEHAVIORAL

SC plus Simple Convergence Exercises (SC+)

In addition to standard community care in this intervention the participants must perform convergence therapy every day at home

BEHAVIORAL

SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)

In addition to standard community care in this intervention the participants must come to the office once a week for a 1-hour therapy session with a therapist. Office-based vergence/accommodative therapy is performed for 12 weeks with home reinforcement.

Sponsors & Collaborators

• Ohio State University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Marshall B. Ketchum University

  collaborator UNKNOWN

• Stanford University

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• New Jersey Institute of Technology

  collaborator OTHER

• Mitchell Scheiman

  lead OTHER

Principal Investigators

• Mitchell Scheiman, OD, PhD · Salus University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• United States

Study Locations