Baranowski Rob, Amschler John, Wittwer Dave, Arendash Gary W
Left Coast Engineering, Escondido, CA, USA.
Ocotillo Electromagnetics, Phoenix, AZ, USA.
Phys Eng Sci Med. 2025 Mar;48(1):239-250. doi: 10.1007/s13246-024-01508-8. Epub 2025 Jan 6.
We have previously shown in small studies that full brain Transcranial Radiofrequency Wave Treatment (TRFT) to subjects with Alzheimer's Disease could stop and reverse their cognitive decline. An 8-emitter head device, the "MemorEM", was used in these studies to provide TRFT at 915 MHz frequency and power level of 1.6 W/kg Specific Absorption Rate (SAR) during daily 1-hour treatments. Although no deleterious side effects during up to 2.5 years of treatment were reported, it is important to rule out the possibility that brain heating will occur during TRFT in humans at a higher power level of 4.0 W/kg SAR, which is anticipated for future clinical testing in order to increase treatment intensity/efficacy to deep sub-cortical areas. To examine if brain heating occurs during a single 1-hour treatment at 4 W/kg SAR, a hollow human head phantom filled with brain-analogous gel and with an attached MemorEM head device was utilized. Brain temperatures were taken at 64 specific coordinates within the brain gel before and immediately following one-hour of TRFT. Results revealed none of the 64 sites having a temperature increase after TRFT of 1 °C or more. Indeed, 45 of the 64 sites exhibited a temperature rise of less than 0.5 °C, with just three sites exhibiting an increase between 0.75 and 0.9 °C. These results demonstrate that TRFT in a human head phantom that mimics the electromagnetic properties of the human head, does not appreciably increase brain temperature (i.e., is non-thermal) at 915 MHz frequency and 4 W/kg SAR power level. Thus, TRFT would appear to be safe at 4 W/kg for long-term daily treatments.
我们之前在小型研究中表明,对阿尔茨海默病患者进行全脑经颅射频波治疗(TRFT)可以阻止并逆转他们的认知衰退。在这些研究中,使用了一种8发射器头部装置“MemorEM”,在每日1小时的治疗过程中,以915兆赫的频率和1.6瓦/千克比吸收率(SAR)的功率水平提供TRFT。尽管在长达2.5年的治疗期间未报告有有害副作用,但排除在4.0瓦/千克SAR的更高功率水平下,人体TRFT过程中发生脑部发热的可能性很重要,这一更高功率水平预计将用于未来的临床试验,以提高对皮质下深部区域的治疗强度/疗效。为了研究在4瓦/千克SAR下进行单次1小时治疗期间是否会发生脑部发热,使用了一个填充有类似脑凝胶并附有MemorEM头部装置的空心人体头部模型。在TRFT治疗1小时之前和之后,在脑凝胶内的64个特定坐标处测量脑温。结果显示,64个部位在TRFT后温度升高均未达到1℃或更高。实际上,64个部位中有45个部位的温度升高小于0.5℃,只有3个部位的温度升高在0.75至0.9℃之间。这些结果表明,在模拟人体头部电磁特性的人体头部模型中,915兆赫频率和4瓦/千克SAR功率水平下的TRFT不会明显升高脑温(即无热效应)。因此,对于长期每日治疗而言,4瓦/千克的TRFT似乎是安全的。