Context: Convergence dysfunction following concussion is common. Near point of convergence (NPC) is a quick and easy assessment that may detect oculomotor dysfunction such as convergence insufficiency (CI), but NPC measurements are rarely reported. Convergence dysfunction is treatable in otherwise healthy patients; the effectiveness of oculomotor therapy following concussion is unclear. Objectives: The purpose of this article was to systematically review the literature and answer the following clinical questions: (1) Is performance on NPC negatively affected in patients diagnosed with a concussion compared with pre-injury levels or healthy controls? (2) In patients diagnosed with concussion, what is the effect of oculomotor/vision therapy on NPC break measurements? Evidence Acquisition: The search was conducted in CINAHL, SPORTDiscus, MEDLINE, and PubMed using terms related to concussion, mild traumatic brain injury, convergence, vision, and rehabilitation. Literature considered for review included original research publications that collected measures of NPC break in concussion patients, with a pretest–posttest comparison or comparison with a healthy control group. A literature review was completed; 242 relevant articles were reviewed, with 18 articles meeting criteria for inclusion in the review. Evidence Synthesis: Articles were categorized according to the clinical question they addressed. The patient or participant sample (number, sex, age, and health status), study design, instrumentation, or intervention used, and main results were extracted from each article. Conclusions: The authors' main findings suggest that there is a moderate level of evidence that patients have impaired NPC up to several months postconcussion, and a low level of evidence that impairments can be successfully treated with oculomotor therapy. These findings should be cautiously evaluated; the studies are limited by weak/moderate quality, small sample sizes, varied methodology, and nonrandomized treatment groups. Future research should explore factors affecting convergence postconcussion and include randomized, controlled studies to determine if performing vision therapy improves visual measures and promotes recovery.
Our findings suggest that the tandem-gait test had a high false-positive rate in high school athletes. Given that more than 75% of healthy participants failed the tandem-gait test, the 14-second cutoff appears to have limited clinical utility in the adolescent population. Functional movement deficits after concussion need to be accounted for, but the 14-second cutoff for the SCAT3 tandem-gait test does not appear to be an ideal way to assess these deficits in high school athletes.
Despite advances in therapy, glioblastoma (GBM) remains one of the most deadly cancers, with five-year survival under 5%. Newer immunotherapies hold promise in the treatment of GBM, and T cell-enabling therapies may improve progression-free and overall survival for newly-diagnosed patients. Checkpoint inhibitors, such as PD-1 inhibitors, have increased response rates in many cancers, but not yet in GBM. In this study, a novel antigen-specific T cell-generating therapy, INO-5401, combined with INO-9012, together with a PD-1 checkpoint inhibitor, cemiplimab, will be given to patients with newly-diagnosed GBM in order to evaluate tolerability, immunogenicity and any activity of the combination. INO-5401 is a mixture of three synthetic plasmids that target Wilms tumor gene-1 (WT-1) antigen, prostate specific membrane antigen (PSMA), and human telomerase reverse transcriptase (hTERT) antigen. INO-9012 is a plasmid encoding human interleukin-12 (IL-12) p35 and p40 subunit proteins. In preclinical studies, targeting WT-1, PSMA and hTERT induced robust cellular immune responses and slowed tumor growth in murine tumor implantation and ALL models. This is a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with cemiplimab, and radiation and chemotherapy, in participants with newly-diagnosed GBM. INO-5401 + INO-9012 will be administered Q3w for the first four doses, and then Q9w until disease progression. Cemiplimab will be administered Q3w until disease progression. The trial population is divided into two cohorts: Cohort A are patients with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter; and Cohort B are patients with a methylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Both cohorts will receive radiation and temozolomide (TMZ), if clinically indicated, in combination with study therapies. Cohort B will continue TMZ for a total of 6 cycles. A safety run-in will be performed with up to six participants (safety analysis participants) from Cohort A and Cohort B. Correlative studies include the assessment of antigen-specific cellular immune responses in peripheral blood and tumor tissue. Fifty-two patients are estimated to be enrolled, 32 in Cohort A and 18 in Cohort B. Enrollment began in May of 2018 and the trial is continuing to accrue as planned. Citation Format: David Reardon, Seema Nagpal, Scott Soltys, Steven Brem, Antonio Omuro, Macarena De La Fuente, Amy-Lee Bredlau, Isreal Lowy, Matthew Fury, Matthew Morrow, Kim Kraynyak, Trevor McMullan, Ashley L. Santo, Brian Sacchetta, Jeffrey Skolnik. INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab (REGN2810) in newly-diagnosed glioblastoma (GBM) (NCT03491683) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT114.
BackgroundA tandem gait assessment is recommended after concussion. There is limited research examining psychometric properties of tandem gait assessments.ObjectiveTo determine tandem gait test intertrial and 1‐week test–retest reliability. It was hypothesized that the tandem gait test would yield moderate to good reliability, times would improve across trials/sessions, and average scores would have higher reliability.DesignReliability study.SettingResearch laboratory.InterventionsSixty participants (36 females, age: 20.4 ± 1.8 years) completed 10 tandem gait test trials on two occasions.Main Outcome MeasuresDependent variables included number of normal trials (participants stayed on the line, heel and toe touched on every step, and they avoided touching an examiner/object) and times for each trial. We analyzed intertrial reliability using a one‐way analysis of covariance and intraclass correlation coefficients (ICC), and test–retest reliability using dependent samples t‐tests and ICCs.ResultsAt the first testing session, there were significant differences in times across seven trials (F2.44,80.42 = 21.55, p < .001). All trials were faster than the first trial. The second, third, and fifth trial were faster than the previous trial. There was moderately high overall reliability across the first seven trials (ICC2,1 = 0.77, 95% confidence interval = 0.63, 0.87). All times were faster at the second testing session (compared to the first). Most outcomes for the 1‐week test–retest reliability demonstrated at least moderate reliability, including the best times for the first three, four, and five trials; average times for the first four and five trials; and best and average times for all of the participants' normal trials during five and 10 attempted trials.ConclusionsThere are practice effects when administering multiple tandem gait test trials, but scores stabilize after the fifth trial. There are practice effects associated with multiple administrations of the tandem gait test, but outcomes using times for four or five trials have adequate 1‐week test–retest reliability in healthy physically active young adults.
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