Persistent Post-Concussion Symptoms With Convergence Insufficiency

Summary

Our successful R01 discovered 1) the neural mechanistic difference between typically occurring convergence insufficiency (TYP-CI) and binocularly normal controls and 2) the underlying mechanism of office-based vergence and accommodative therapy (OBVAT) that is effective in remediating symptoms. Adolescent and young adult concussion is considered a substantial health problem in the United States where our team has shown that about half of patients with persistent post-concussion symptoms have convergence insufficiency (PPCS-CI), causing significant negative impact associated with reading or digital screen-related activities, and is believed to be one factor causing delayed recovery impacting return to school, sports, or work. The results of this randomized clinical trial will impact the lives of adolescents and young adults with PPCS-CI to guide professionals on how to manage and treat those with PPCS-CI by 1) comparing the differences between PPCS-CI and TYP-CI, 2) discovering the neural mechanism of OBVAT for PPCS-CI compared to standard-community concussion care, and 3) determining the effectiveness of 12 one-hour sessions compared to 16 one-hour sessions of OBVAT.

Conditions

• Persistent Post-concussive Symptoms
• Convergence Insufficiency
• Mild Traumatic Brain Injury
• Concussion, Mild
• Concussion; Eye

Interventions

BEHAVIORAL

Office-based Vergence and Accommodative Therapy

Office-based Vergence and Accommodative Therapy has four phases which start with gross vergence and accommodation. Disparity vergence is isolated using instruments such as vectograms and accommodation is isolated using near far charts and accommodative rock. The final phase includes the integration of vergence and accommodation to increase range and visual comfort which performing activities close to the person.

Sponsors & Collaborators

• Salus University

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• Rutgers University

  collaborator OTHER

• New Jersey Institute of Technology

  lead OTHER

Principal Investigators

• Tara L Alvarez, PhD · New Jersey Institute of Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2026-01-19

Completion

2026-01-19

Countries

• United States

Study Locations