Department of Biomedical Engineering, New Jersey Institute of Technology, Newark, New Jersey, United States of America.
Pennsylvania College of Optometry, Salus University, Philadelphia, Pennsylvania, United States of America.
PLoS One. 2024 Nov 15;19(11):e0314027. doi: 10.1371/journal.pone.0314027. eCollection 2024.
To 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.
CONCUSS 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.
Major 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.
描述 CONCUSS，这是一项随机临床试验（RCT），旨在比较以下两种治疗方法：即时办公室基于调节/集合疗法与运动（OBVAM）与延迟 OBVAM 治疗与脑震荡相关的集合不足（CONC-CI），以了解时间（观察等待）的影响，OBVAM 剂量的影响（12 次与 16 次治疗），并研究 OBVAM 对 CONC-CI 参与者的潜在神经机制。
CONCUSS 是一项在 https://clinicaltrials.gov/study/NCT05262361 上注册的 RCT，纳入了 100 名年龄在 11-25 岁之间的参与者，这些参与者患有经医学诊断的脑震荡，在受伤后 4-24 周有持续的脑震荡后症状，且有症状性集合不足。参与者将接受标准的脑震荡护理，并随机分为即时 OBVAM 组或延迟（6 周后）OBVAM 组。在结果 1 检查（第 7 周）时，将比较两组治疗前后近点集合（NPC）、正融像性集合（PFV）和症状变化的临床评估。在第一次就诊后，延迟组接受 16 次 OBVAM 治疗，而即时 OBVAM 组再接受 4 次治疗。在参与者接受 16 次 OBVAM 治疗后，将使用结果 2 评估来比较两组。主要测量指标是结果 1 就诊时 NPC 和 PFV 复合变化的组间差异。次要结局指标包括个体临床指标、客观眼动追踪参数和功能脑成像。
研究设计的主要特点包括对条件和结局的正式定义、标准化的诊断和治疗方案、延迟治疗组、盲法结局检查，以及纳入客观眼球运动记录和脑成像作为结局测量。CONCUSS 将为 CONC-CI 的临床护理确立最佳实践。客观眼球运动和脑成像与临床体征和症状相关，将确定 OBVAM 对 CONC-CI 的神经机制。
