Evidence map›Paper›PMID 39546477›Full record

ArticlePloS one2024

Effectiveness of treatment for concussion-related convergence insufficiency: The CONCUSS study protocol for a randomized clinical trial.

Tara L Alvarez, Mitchell Scheiman, Suril Gohel, Farzin Hajebrahimi, Melissa Noble, Ayushi Sangoi, Chang Yaramothu, Christina L Master, Arlene Goodman

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05262361 (Functional Mechanism of Neural Control in Persistent Post-Concussion Symptoms Convergence Insufficiency), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05262361 nacompletednot on this map

Functional Mechanism of Neural Control in Persistent Post-Concussion Symptoms Convergence Insufficiency

TypeinterventionalSponsorNew Jersey Institute of TechnologyRan2021 to 2026Enrolled112ConditionsPersistent Post-concussive Symptoms, Convergence Insufficiency, Mild Traumatic Brain Injury, Concussion, MildArmsOffice-based Vergence and Accommodative Therapy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
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  4. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Tara L AlvarezDepartment of Biomedical Engineering, New Jersey Institute of Technology, Newark, New Jersey, United States of America.
Mitchell ScheimanPennsylvania College of Optometry, Salus University, Philadelphia, Pennsylvania, United States of America.
Suril GohelDepartment of Health Informatics, Rutgers University School of Health Professions, Newark, New Jersey, United States of America.
Farzin HajebrahimiDepartment of Biomedical Engineering, New Jersey Institute of Technology, Newark, New Jersey, United States of America.ORCID 0000-0002-5286-4981
Melissa NobleDepartment of Biomedical Engineering, New Jersey Institute of Technology, Newark, New Jersey, United States of America.
Ayushi SangoiDepartment of Biomedical Engineering, New Jersey Institute of Technology, Newark, New Jersey, United States of America.ORCID 0000-0003-4151-4940
Chang YaramothuSchool of Applied Engineering and Technology, New Jersey Institute of Technology, Newark, New Jersey, United States of America.ORCID 0000-0003-4442-5409
Christina L MasterSports Medicine and Performance Center, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.
Arlene GoodmanSomerset Pediatric Group, Raritan, New Jersey, United States of America.

Funding

Functional Mechanisms of Neural Control in Convergence InsufficiencyR01EY023261 · NEI · NEW JERSEY INSTITUTE OF TECHNOLOGY · PI ALVAREZ, TARA LYNN · 2014 to 2025
$4.9M
NEI NIH HHS R01 EY023261
6 · The paper itself

Abstract

purposeTo describe CONCUSS, a randomized clinical trial (RCT) designed to compare the following: the effectiveness of immediate office-based vergence/accommodative therapy with movement (OBVAM) to delayed OBVAM as treatments for concussion-related convergence insufficiency (CONC-CI) to understand the impact of time (watchful waiting), the effect of OBVAM dosage (12 versus 16 therapy sessions), and to investigate the underlying neuro-mechanisms of OBVAM on CONC-CI participants.

methodsCONCUSS is an RCT indexed on https://clinicaltrials.gov/study/NCT05262361 enrolling 100 participants aged 11-25 years with medically diagnosed concussion, persistent post-concussive symptoms 4-24 weeks post-injury, and symptomatic convergence insufficiency. Participants will receive standard concussion care and will be randomized to either immediate OBVAM or delayed (by six weeks) OBVAM. At the Outcome 1 examination (week 7), clinical assessments of success as determined by changes in the near point of convergence (NPC), positive fusional vergence (PFV), and symptoms will be compared between the two treatment groups. After the Outcome 1 visit, those in the delayed group receive 16 visits of OBVAM, while those in the immediate OBVAM group receive four more therapy visits. Outcome 2 assessment will be used to compare both groups after participants receive 16 sessions of OBVAM. The primary measure is the between-group differences of the composite change in the NPC and PFV at the Outcome 1 visit. Secondary outcome measures include individual clinical measures, objective eye-tracking parameters, and functional brain imaging.

conclusionsMajor features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a delayed treatment arm, masked outcome examinations, and the incorporation of objective eye movement recording and brain imaging as outcome measures. CONCUSS will establish best practices in the clinical care of CONC-CI. The objective eye movement and brain imaging, correlated with the clinical signs and symptoms, will determine the neuro-mechanisms of OBVAM on CONC-CI.

Indexed as

Brain ConcussionOcular Motility DisordersRandomized Controlled Trials as TopicAccommodation, OcularAdolescentAdultChildConvergence, OcularFemaleHumansMalePost-Concussion SyndromeTreatment OutcomeYoung Adult

Identifiers

PMID39546477
PMCPMC11567536

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.