Abstract
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
Thirty
30
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.
Keywords
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Article info
Publication history
Published online: April 19, 2020
Accepted:
March 15,
2020
Received in revised form:
February 10,
2020
Received:
December 10,
2019
Identification
DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2020.104816
Copyright
© 2020 Elsevier Inc. All rights reserved.
