Division of Physical Therapy and Rehabilitation Science, Department of Rehabilitation Medicine, School of Medicine, University of Minnesota, MN, Minneapolis, USA.
Department of Neurological Surgery, School of Medicine, University of Virginia, VA, Charlottesville, USA.
Sci Rep. 2020 Mar 27;10(1):5573. doi: 10.1038/s41598-020-62265-8.
Low intensity transcranial focused ultrasound (LIFU) is a promising method of non-invasive neuromodulation that uses mechanical energy to affect neuronal excitability. LIFU confers high spatial resolution and adjustable focal lengths for precise neuromodulation of discrete regions in the human brain. Before the full potential of low intensity ultrasound for research and clinical application can be investigated, data on the safety of this technique is indicated. Here, we provide an evaluation of the safety of LIFU for human neuromodulation through participant report and neurological assessment with a comparison of symptomology to other forms of non-invasive brain stimulation. Participants (N = 120) that were enrolled in one of seven human ultrasound neuromodulation studies in one laboratory at the University of Minnesota (2015-2017) were queried to complete a follow-up Participant Report of Symptoms questionnaire assessing their self-reported experience and tolerance to participation in LIFU research (I 11.56-17.12 W/cm) and the perceived relation of symptoms to LIFU. A total of 64/120 participant (53%) responded to follow-up requests to complete the Participant Report of Symptoms questionnaire. None of the participants experienced serious adverse effects. From the post-hoc assessment of safety using the questionnaire, 7/64 reported mild to moderate symptoms, that were perceived as 'possibly' or 'probably' related to participation in LIFU experiments. These reports included neck pain, problems with attention, muscle twitches and anxiety. The most common unrelated symptoms included sleepiness and neck pain. There were initial transient reports of mild neck pain, scalp tingling and headache that were extinguished upon follow-up. No new symptoms were reported upon follow up out to 1 month. The profile and incidence of symptoms looks to be similar to other forms of non-invasive brain stimulation.
低强度经颅聚焦超声(LIFU)是一种有前途的非侵入性神经调节方法,它利用机械能来影响神经元的兴奋性。LIFU 具有高空间分辨率和可调焦距,可精确调节人脑的离散区域。在充分研究低强度超声的潜力之前,需要提供关于该技术安全性的数据。在这里,我们通过参与者报告和与其他形式的非侵入性脑刺激的症状比较,对 LIFU 用于人类神经调节的安全性进行了评估。在明尼苏达大学的一个实验室(2015-2017 年)进行的七项人类超声神经调节研究中,有 120 名参与者(N=120)被招募,要求他们完成一份后续的症状参与者报告调查问卷,评估他们对参与 LIFU 研究(I 11.56-17.12 W/cm)的自我报告经历和耐受性,以及症状与 LIFU 的感知关系。共有 64/120 名参与者(53%)响应了完成症状参与者报告的后续请求。没有参与者经历严重的不良影响。从使用问卷对安全性的事后评估来看,7/64 名参与者报告了轻度至中度症状,这些症状被认为与参与 LIFU 实验“可能”或“很可能”有关。这些报告包括颈部疼痛、注意力问题、肌肉抽搐和焦虑。最常见的无关症状包括嗜睡和颈部疼痛。最初有轻度颈部疼痛、头皮刺痛和头痛的短暂报告,但在随访时消失。在 1 个月的随访中没有报告新的症状。症状的表现和发生率似乎与其他形式的非侵入性脑刺激相似。
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