NCT03908112

Interventions for Convergence Insufficiency in Concussed Children

Interventions for Convergence Insufficiency in Concussed Children (ICONICC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Mitchell Scheiman · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

Objectives: A group of 264 diverse children, ages 11 to 17 years, with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be enrolled from 6 sites from across the United States, will be randomized to 12 weeks of: 1) standard care (SC), 2) SC plus simple convergence exercises (SC+), and 3) SC plus office-based vergence/ accommodative therapy (SC+OBVAT). Primary Objective: To compare the effectiveness of SC, SC+, SC plus office-based vergence/accommodative therapy for improving a composite outcome measure of clinical findings (near point of convergence and positive fusional vergence at near) in children 11-17 years of age with concussion-related CI after 12 weeks of treatment. * Secondary outcome measures * Objective measures of disparity vergence, accommodation, saccades, and smooth pursuit * Quality of life measures * Convergence Insufficiency Symptom Survey Concussion Version (CISS-CON) * PedsQL Version 4 For participants in any treatment group who not "successful" based on the composite score described above, additional/different treatment will be offered as an option after the primary outcome examination

Conditions

• Concussion
• Convergence Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2019-04-09
• Last updated: 2020-10-23

Locations

8 sites across 1 country: United States