Elsevier

Brain Stimulation

Volume 14, Issue 4, July–August 2021, Pages 1022-1031
Brain Stimulation

Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy

https://doi.org/10.1016/j.brs.2021.06.003Get rights and content
Under a Creative Commons license
open access

Highlights

  • tFUS is a novel brain stimulation technique with not yet fully established safety guidelines.

  • •tFUS was administered to patients electing to undergo resective brain surgery.

  • •tFUS does not appear to cause damage to tissue.

Abstract

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.

Keywords

Focused Ultrasound
Temporal lobe epilepsy
Safety

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