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Research Objectives
Assess safety and explore efficacy of ExaStim, a wireless, portable multi-electrode
neuromodulation system supporting selective non-invasive spinal neuromodulation to
restore upper limb function in spinal cord injury (SCI) patients.
Design
A multi-center, prospective, crossover, blinded study.
Setting
Outpatient rehabilitation clinics and hospitals.
Participants
Individual with traumatic chronic SCI between C5 and T2.
Interventions
Physical therapy paired with Sham stimulation for the first 8 weeks followed by second
8 weeks of active therapeutic stimulation. Transcutaneous multi-channel spinal cord
neuromodulation is delivered through ExaStim.
Main Outcome Measures
Safety: no serious adverse events, per ISO 14155:2020. Effectiveness: International
Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Upper Extremity
Motor Score (UEM) and the Graded Redefined Assessment of Strength, Sensation and Prehension
(GRASSP).
Results
A total of 12 subjects were enrolled; nine completed and three withdrew from study
participation shortly after beginning study therapy. No serious adverse event was
observed during the duration of study. Nine participants treated with ExaStim experienced
a median increase in ISNCSCI UEMS total score of 6.0 points from the baseline. For
the Neurological Level of Injury assessment of the INSCSCI Score, one subject improved
from C4 to C5 and two subjects improved from C6 to C7. For the assessment of the INSCSCI,
one subject improved from B to C, one subject improved from C to D, and a third subject
improved from A to C. However, due to the large variability in the GRASSP scores obtained
using this instrument, no consistent trends could be observed.
Conclusions
The pilot study provides preliminary evidence of treatment safety and possible effectiveness
using ExaStim to improve upper limb function in individuals with SCI. Further investigation
of the device effectiveness and safety is warranted in a larger trial.
Author(s) Disclosures
Dr. Yi-Kai Lo and Rachel Yung are employees of Aneuvo, which owns the intellectual
property of the transcutaneous neuromodulation device used in this study.
Drs. Dimitry Sayenko, Rebecca Martin, and Monica Perez received research funding from
Aneuvo for this study; Drs. Sayenko and Perez consult for Aneuvo.
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© 2022 Published by Elsevier Inc.
