TY - JOUR
T1 - Multifocal transcranial stimulation in chronic ischemic stroke
T2 - A phase 1/2a randomized trial
AU - Chiu, David
AU - McCane, C. David
AU - Lee, Jason
AU - John, Blessy
AU - Nguyen, Lisa
AU - Butler, Kayla
AU - Gadhia, Rajan
AU - Misra, Vivek
AU - Volpi, John J.
AU - Verma, Amit
AU - Helekar, Santosh A.
N1 - Funding Information:
This study was funded by grants from the Translational Research Initiative of the Houston Methodist Research Institute and Seraya Medical, LLC to Drs. Helekar and Chiu. We thank Dr. Susan Xu, Ph.D. of Houston Methodist Research Institute for conducting statistical analysis of the data.
Funding Information:
This study was funded by grants from the Translational Research Initiative of the Houston Methodist Research Institute and Seraya Medical, LLC to Drs. Helekar and Chiu. We thank Dr. Susan Xu, Ph.D. of Houston Methodist Research Institute for conducting statistical analysis of the data. Declaration of Competing Interest: Dr. Helekar is listed as an inventor on U.S. patent numbers 9456784, 10398907 and 10500408 covering the device used in this study. The patent is licensed to Seraya Medical, LLC. On behalf of all other authors, the corresponding author states that they do not have a conflict of interest.
Publisher Copyright:
© 2020 Elsevier Inc.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/6
Y1 - 2020/6
N2 - Background and Purpose: Repetitive transcranial magnetic stimulation (rTMS) may promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits. The objective of this study was to examine whether multifocal cortical stimulation using a new wearable transcranial rotating permanent magnet stimulator (TRPMS) can promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits. Methods: Thirty30 patients with chronic ischemic stroke and stable unilateral weakness were enrolled in a Phase 1/2a randomized double-blind sham-controlled clinical trial to evaluate safety and preliminary efficacy. Bilateral hemispheric stimulation was administered for 20 sessions 40 min each over 4 weeks. The primary efficacy endpoint was the change in functional MRI BOLD activation immediately after end of treatment. Secondary efficacy endpoints were clinical scales of motor function, including the Fugl-Meyer motor arm score, ARAT, grip strength, pinch strength, gait velocity, and NIHSS. Results: TRPMS treatment was well-tolerated with no device-related adverse effects. Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs -30, p = 0.038). The median active voxel number after active treatment was 8.8-fold greater than after sham (227.5 vs 26, p = 0.016). Although the statistical power was inadequate to establish clinical endpoint benefits, numerical improvements were demonstrated in 5 of 6 clinical scales of motor function. The treatment effects persisted over a 3-month duration of follow-up. Conclusions: Multifocal bilateral TRPMS was safe and showed significant fMRI changes suggestive of functional reorganization of cortical circuits in patients with chronic ischemic stroke. A larger randomized clinical trial is warranted to verify recovery of motor function.
AB - Background and Purpose: Repetitive transcranial magnetic stimulation (rTMS) may promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits. The objective of this study was to examine whether multifocal cortical stimulation using a new wearable transcranial rotating permanent magnet stimulator (TRPMS) can promote recovery of motor function after stroke by inducing functional reorganization of cortical circuits. Methods: Thirty30 patients with chronic ischemic stroke and stable unilateral weakness were enrolled in a Phase 1/2a randomized double-blind sham-controlled clinical trial to evaluate safety and preliminary efficacy. Bilateral hemispheric stimulation was administered for 20 sessions 40 min each over 4 weeks. The primary efficacy endpoint was the change in functional MRI BOLD activation immediately after end of treatment. Secondary efficacy endpoints were clinical scales of motor function, including the Fugl-Meyer motor arm score, ARAT, grip strength, pinch strength, gait velocity, and NIHSS. Results: TRPMS treatment was well-tolerated with no device-related adverse effects. Active treatment produced a significantly greater increase in the number of active voxels on fMRI than sham treatment (median +48.5 vs -30, p = 0.038). The median active voxel number after active treatment was 8.8-fold greater than after sham (227.5 vs 26, p = 0.016). Although the statistical power was inadequate to establish clinical endpoint benefits, numerical improvements were demonstrated in 5 of 6 clinical scales of motor function. The treatment effects persisted over a 3-month duration of follow-up. Conclusions: Multifocal bilateral TRPMS was safe and showed significant fMRI changes suggestive of functional reorganization of cortical circuits in patients with chronic ischemic stroke. A larger randomized clinical trial is warranted to verify recovery of motor function.
KW - Chronic ischemic stroke
KW - Functional magnetic resonance imaging
KW - Neuromodulation
KW - Neuroplasticity
KW - Transcranial magnetic stimulation
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U2 - 10.1016/j.jstrokecerebrovasdis.2020.104816
DO - 10.1016/j.jstrokecerebrovasdis.2020.104816
M3 - Article
C2 - 32321651
AN - SCOPUS:85083322864
VL - 29
JO - Journal of Stroke and Cerebrovascular Diseases
JF - Journal of Stroke and Cerebrovascular Diseases
SN - 1052-3057
IS - 6
M1 - 104816
ER -