Rindner Elisabeth S, Haroon Jonathan M, Jordan Kaya G, Mahdavi Kennedy D, Surya Jean R, Zielinski Margaret A, Habelhah Barshen, Venkatraman Victoria, Becerra Sergio A, Chan Lider, Kuhn Taylor P, Jordan Sheldon E
The Regenesis Project, Los Angeles, CA, USA.
Synaptec Network, Los Angeles, CA, USA.
J Lasers Med Sci. 2022 Dec 13;13:e65. doi: 10.34172/jlms.2022.65. eCollection 2022.
This study intended to evaluate the safety and possible therapeutic effect of transcranial infrared laser stimulation (TILS) based on photobiomodulation (PBM) among patients with traumatic brain injury (TBI). Eleven participants who were diagnosed with TBI after full neurological examination and MRI evaluation by a board-certified neurologist completed five to eight 20-minute TILS sessions using the Cytonsys CytonPro-5000 apparatus (pilot laser control, focused wavelength of 1064 nm, maximum output power of 10W, maximum optical power density of 500 mW/cm, effective area 4.5 cm in diameter). Per TILS session, participants underwent a laser dose of 250 mW/cm continuous laser wave to each hemisphere using predetermined patient-specific coordinates. Structural imaging was used to neuronavigate individual treatment targets in the frontal cortex (Brodmann area 10). The primary safety measure for this study was the occurrence of adverse events (AEs) or serious adverse events (SAEs). The primary efficacy outcome measure was the participant-rated global rating of change (GRC) post-intervention. Secondary outcome measures included a battery of neuropsychological testing and mood questionnaires done both pre- and post-intervention. All patients enrolled in this study protocol were able to tolerate the study procedures without any AEs or SAEs. Nine out of eleven participants had clinically significant improvements in GRC score (≥ +2). Neuropsychological testing and mood questionnaire outcomes also suggested a positive therapeutic effect. This study provides preliminary evidence supporting the safety and potential efficacy of TILS as a non-invasive clinical intervention for individuals with TBI.
本研究旨在评估基于光生物调节作用（PBM）的经颅红外激光刺激（TILS）对创伤性脑损伤（TBI）患者的安全性及可能的治疗效果。11名经专业神经科医生进行全面神经学检查及MRI评估后确诊为TBI的参与者，使用Cytonsys CytonPro - 5000设备（先导激光控制，聚焦波长1064nm，最大输出功率10W，最大光功率密度500mW/cm，有效面积直径4.5cm）完成了5至8次每次20分钟的TILS治疗。每次TILS治疗时，参与者使用预先确定的个体化坐标，对每个半球接受250mW/cm的连续激光波照射剂量。采用结构成像技术对额叶皮质（布罗德曼10区）的个体治疗靶点进行神经导航。本研究的主要安全指标是不良事件（AE）或严重不良事件（SAE）的发生情况。主要疗效指标是干预后参与者评定的整体变化评分（GRC）。次要疗效指标包括干预前后进行的一系列神经心理学测试和情绪问卷。所有纳入本研究方案的患者均能耐受研究程序，未出现任何AE或SAE。11名参与者中有9名在GRC评分上有临床显著改善（≥ +2）。神经心理学测试和情绪问卷结果也提示了积极的治疗效果。本研究提供了初步证据，支持TILS作为TBI患者的一种非侵入性临床干预措施的安全性和潜在疗效。
