Objective

Transcranial Focused Ultrasound (tFUS) is a promising new potential neuromodulation tool. However, the safety of tFUS neuromodulation has not yet been assessed adequately. Patients with refractory temporal lobe epilepsy electing to undergo an anterior temporal lobe resection present a unique opportunity to evaluate the safety and efficacy of tFUS neuromodulation. Histological changes in tissue after tFUS can be examined after surgical resection, while further potential safety concerns can be assessed using neuropsychological testing.

Methods

Neuropsychological functions were assessed in eight patients before and after focused ultrasound sonication of the temporal lobe at intensities up to 5760 mW/cm². Using the BrainSonix Pulsar 1002, tFUS was delivered under MR guidance, using the Siemens Magnetom 3T Prisma scanner. Neuropsychological changes were assessed using various batteries. Histological changes were assessed using hematoxylin and eosin staining, among others.

Results

With respect to safety, the histological analysis did not reveal any detectable damage to the tissue, except for one subject for whom the histology findings were inconclusive. In addition, neuropsychological testing did not show any statistically significant changes in any test, except for a slight decrease in performance on one of the tests after tFUS.

Significance

This study supports the hypothesis that low-intensity Transcranial Focused Ultrasound (tFUS) used for neuromodulation of brain circuits at intensities up to 5760 mW/cm² may be safe for use in human research. However, due to methodological limitations in this study and inconclusive findings, more work is warranted to establish the safety. Future directions include greater number of sonications as well as longer exposure at higher intensity levels to further assess the safety of tFUS for modulation of neuronal circuits.

中文翻译：

---

聚焦超声神经调节对颞叶癫痫患者的安全性

客观的

经颅聚焦超声 (tFUS) 是一种很有前景的新型潜在神经调节工具。然而，tFUS 神经调节的安全性尚未得到充分评估。选择接受前颞叶切除术的难治性颞叶癫痫患者提供了一个独特的机会来评估 tFUS 神经调节的安全性和有效性。可以在手术切除后检查 tFUS 后组织的组织学变化，同时可以使用神经心理学测试评估进一步的潜在安全问题。

方法

在对颞叶进行聚焦超声超声处理之前和之后，评估了 8 名患者的神经心理功能，强度高达 5760 mW/cm ²。使用 BrainSonix Pulsar 1002，在 MR 引导下使用 Siemens Magnetom 3T Prisma 扫描仪进行 tFUS。使用各种电池评估神经心理变化。使用苏木精和伊红染色等评估组织学变化。

结果

关于安全性，组织学分析没有显示任何可检测到的组织损伤，除了一位受试者的组织学结果尚无定论。此外，神经心理学测试在任何测试中都没有显示出任何统计学上的显着变化，除了在 tFUS 后其中一项测试的表现略有下降。

意义

该研究支持以下假设，即用于脑回路神经调节的低强度经颅聚焦超声 (tFUS) 在强度高达 5760 mW/cm ^{2 时}可安全用于人类研究。然而，由于本研究的方法学局限性和不确定的结果，需要做更多的工作来确定安全性。未来的方向包括更多的超声处理以及在更高强度水平下更长时间的暴露，以进一步评估 tFUS 用于调节神经元回路的安全性。