4.6 Article

Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy

Journal

BRAIN STIMULATION
Volume 14, Issue 4, Pages 1022-1031

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.brs.2021.06.003

Keywords

Focused Ultrasound; Temporal lobe epilepsy; Safety

Funding

  1. BrainSonix Corporation
  2. Friedman Foundation
  3. Elizabeth R. Koch Foundation

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The study examined the safety and efficacy of Transcranial Focused Ultrasound (tFUS) neuromodulation in patients with refractory temporal lobe epilepsy undergoing surgery. Results showed that tFUS at intensities up to 5760 mW/cm(2) may be safe, with no detectable tissue damage and minimal changes in neuropsychological testing. Further research is needed due to methodological limitations and inconclusive findings.
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/cm(2). 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/cm(2) 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. (C) 2021 The Authors. Published by Elsevier Inc.

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