Persistent Post-Concussion Symptoms With Convergence Insufficiency

NCT05262361 | Completed

• 1 other identifier: 2R01EY023261
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Near Point of Convergence with Positive Fusional Vergence

  Composite score of how close a participant can view a target a single along midline combined with positive fusional vergence range.

  after 12 therapy session spanning 6 weeks

Secondary Outcomes (2)

• Vergence Peak Velocity

  after 12 therapy session spanning 6 weeks

• Functional Activity within vergence neural circuit

  after 12 therapy session spanning 6 weeks

Study Arms (2)

Office based Vergence and Accommodative Therapy immediately after enrollement

EXPERIMENTAL

This arm will start immediately after baseline assessment. The participant will have two sessions of one hour each for 6 weeks (12 office-based vergence and accommodative therapy sessions). The first outcome measurement will be attained by a masked optometrist. Then, the participant will have 2 more weeks of therapy (4 office-based vergence and accommodative therapy sessions). The second and final outcome measurement will be attained. Assessments include a masked optometric vision exam, objective eye movement recordings and an functional MRI scan.

Behavioral: Office-based Vergence and Accommodative Therapy

Office based Vergence and Accommodative Therapy Delay 6 weeks post enrollment

NO INTERVENTION

This arm will start with a 6 week delay (no vision therapy) after baseline assessment to evaluate natural recovery. After 6 weeks, the first outcome assessment will be attained by a masked optometrist. The participant will have two sessions of one hour each for 8 weeks (16 office-based vergence and accommodative therapy sessions). The second and final outcome measurement will be attained. Assessments include a masked optometric vision exam, objective eye movement recordings and an functional MRI scan.

Interventions

Office-based Vergence and Accommodative Therapy BEHAVIORAL

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.

Office based Vergence and Accommodative Therapy immediately after enrollement

Eligibility Criteria

• Age: 11 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between 11 to 35 years
• Concussion diagnosed by a clinical 1 to 6 months ago
• Best-corrected visual acuity of 20/25 in both eyes at distance and near
• willing to wear glasses or contact to correct refractive error if needed
• Global stereopsis of 500 sec of arc or better and 70 sec of arc of better using Randot Stereo Test
• Diagnosis of convergence insufficiency from an optometrist defined as near point of convergence of greater than or equal to 6 cm, positive fusional vergence at 40 cm not meeting Sheard's criteria of at least twice the near phoria or a range of less than or equal to 15 prism diopters, and a convergence insufficiency symptom survey score of 21 or greater for adults or 16 or greater for children.

You may not qualify if:

• History of performing office or home-based vision therapy, orthoptics, home-based near target push-ups, or pencil push ups
• Amblyopia (lazy eye) or constant strabismus or strabismus surgery
• Any conditions or diseases that affect accommodation, vergence or ocular motility, such as Multiple Sclerosis, Graves' thyroid disease, Myastheria Gravis, Diabetes, Chemotherapy, or Parkinson's Disease
• Non-removable metal in the body
• Pregnant, planning on becoming pregnant during the study duration, or breastfeeding
• Metal worker

Sponsors & Collaborators

• Salus University: collaborator
• Children's Hospital of Philadelphia: collaborator
• National Eye Institute (NEI): collaborator
• Rutgers University: collaborator
• New Jersey Institute of Technology: lead

Study Sites (2)

NJIT

Newark, New Jersey, 07102, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Alvarez TL, Scheiman M, Hajebrahimi F, Noble M, Gohel S, Baro R, Bachman JA, Master CL, Goodman A; CONCUSS Investigator Group. CONCUSS randomised clinical trial of vergence/accommodative therapy for concussion-related symptomatic convergence insufficiency. Br J Sports Med. 2025 Oct 1:bjsports-2025-109807. doi: 10.1136/bjsports-2025-109807. Online ahead of print.

  PMID: 41033748 DERIVED

• Alvarez TL, Scheiman M, Gohel S, Hajebrahimi F, Noble M, Sangoi A, Yaramothu C, Master CL, Goodman A. Effectiveness of treatment for concussion-related convergence insufficiency: The CONCUSS study protocol for a randomized clinical trial. PLoS One. 2024 Nov 15;19(11):e0314027. doi: 10.1371/journal.pone.0314027. eCollection 2024.

  PMID: 39546477 DERIVED

MeSH Terms

Conditions

Ocular Motility Disorders; Brain Concussion

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Tara L Alvarez, PhD

  New Jersey Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The optometrist will be masked for all outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The are two arms. Arm 1 will have participants will have office-based vergence and accommodative therapy (twice per week) immediately after enrollment while arm 2 will have participants have a 6 week delay before enrollment of therapy. There are three assessments: baseline, outcome 1 which is at 6 weeks (arm 1 would be after 12 sessions of therapy and arm 2 would not have participants in vision therapy yet), and outcome 2 which after vision therapy.

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: September 1, 2021
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after end of study
• Access Criteria: FITBIR or email (tara.l.alvarez@njit.edu) to the principal investigator

Locations

US (2)