背景:具有不可逆视野丧失的青光眼患者经常经历生活质量下降,行动不便,和心理健康挑战。感知学习(PL)和经颅电刺激(tES)已成为视力康复的有希望的干预措施,显示出恢复剩余视觉功能的潜力。使用ElectricAI经颅刺激(GREAT)的青光眼康复项目旨在研究结合PL和tES是否比单独使用两种方法更有效地最大化青光眼患者的视觉功能。此外,这项研究将评估这些干预措施对脑神经活动的影响,血液生物标志物,移动性,心理健康,生活质量,害怕跌倒。
方法:该研究采用了三臂,双盲,随机化,优势控制设计。参与者以1:1:1的比例随机分配到以下三组中的一组:(1)真实PL和真实tES,(2)真实PL和假TES,和(3)安慰剂PL和假tES。每个参与者每个区块经历10个会话(每个约1小时),总共三个街区。在六个时间点进行评估:基线,临时1,临时2,干预后,干预后1个月,干预后2个月。主要结果是汉弗莱视野分析仪测量的24-2视野的平均偏差。次要结果包括阈值上视野的检出率,平衡和步态功能,以及电生理和生物反应。这项研究还调查了神经递质代谢的变化,生物标志物,自我感知的生活质量,干预前后的心理状况。
结论:GREAT项目是第一个评估PL和tES在青光眼康复中的有效性的研究。我们的研究结果将全面评估这些治疗方法对广泛的大脑和视觉相关指标的影响,包括视野,神经活动,生物标志物,移动性,心理健康,害怕跌倒,和生活质量。
背景:ClinicalTrials.govNCT05874258。2023年5月15日注册。
BACKGROUND: Glaucoma patients with irreversible visual field loss often experience decreased quality of life, impaired mobility, and mental health challenges. Perceptual learning (PL) and transcranial electrical stimulation (tES) have emerged as promising interventions for vision rehabilitation, showing potential in restoring residual visual functions. The Glaucoma Rehabilitation using ElectricAI Transcranial stimulation (GREAT) project aims to investigate whether combining PL and tES is more effective than using either method alone in maximizing the visual function of glaucoma patients. Additionally, the
study will assess the impact of these interventions on brain neural activity, blood biomarkers, mobility, mental health, quality of life, and fear of falling.
METHODS: The
study employs a three-arm, double-blind, randomized, superiority-controlled design. Participants are randomly allocated in a 1:1:1 ratio to one of three groups receiving: (1) real PL and real tES, (2) real PL and sham tES, and (3) placebo PL and sham tES. Each participant undergoes 10 sessions per block (~ 1 h each), with a total of three blocks. Assessments are conducted at six time points: baseline, interim 1, interim 2, post-intervention, 1-month post-intervention, and 2-month post-intervention. The primary outcome is the mean deviation of the 24-2 visual field measured by the Humphrey visual field analyzer. Secondary outcomes include detection rate in the suprathreshold visual field, balance and gait functions, and electrophysiological and biological responses. This
study also investigates changes in neurotransmitter metabolism, biomarkers, self-perceived quality of life, and psychological status before and after the intervention.
CONCLUSIONS: The GREAT project is the first
study to assess the effectiveness of PL and tES in the rehabilitation of glaucoma. Our findings will offer comprehensive assessments of the impact of these treatments on a wide range of brain and vision-related metrics including visual field, neural activity, biomarkers, mobility, mental health, fear of falling, and quality of life.
BACKGROUND: ClinicalTrials.gov NCT05874258 . Registered on May 15, 2023.