Transcranial Magnetic Stimulation on spasticity in Multiple Sclerosis – protocol for a feasibility study for a randomized, crossover clinical trial
DOI:
https://doi.org/10.1590/Keywords:
Multiple Sclerosis, Muscle Spasticity, Transcranial Magnetic StimulationAbstract
Spasticity is a common sequela of multiple
sclerosis (MS) that can cause pain, deformities, and impair
movement. Transcranial magnetic stimulation (TMS) has
been investigated for the treatment of spasticity; however,
further investigation is needed. This study aimed to compare
the effect of high and low frequency TMS on quadriceps
spasticity in MS. Adults diagnosed with MS and who present
bilateral quadriceps spasticity will undergo two treatment
sessions with TMS. The first session will be randomized to
receive high (≥5Hz) or low frequency (≤1Hz) TMS over the left motor cortex; after one week they will receive the second
session, which will be the opposite. Spasticity will be assessed
bilaterally, before and after each intervention, using the Ashworth
scale, the latency of TMS to the quadriceps muscles, the amplitude
of the motor evoked potential, the central motor conduction time,
the latency time of the patellar reflex, and the amplitude of the
quadriceps pendulum test. Statistical analyses will be carried out
using the SPSS Statistic program, version 26, with a significance
level of p<0.05. The Shapiro-Wilk test will be used to analyze the
normality of the variables. Parametric data will be represented
as mean and standard deviation and non-parametric data will be
represented as median and interquartile range, and frequency and
percentage for categorical variables. For the primary outcome, the
two-way analysis of variance will be used for parametric data, and
the Friedman’s test for non-parametric data.
Downloads
References
Perez CA, Cuascut FX, Hutton GJ. Immunopathogenesis,
diagnosis, and treatment of multiple sclerosis: a clinical update.
Neurol Clin. 2023;41(1):87-106. doi: 10.1016/j.ncl.2022.05.004
Boutiére C, Rey C, Zaaraoui W, Le Troter A, Rico A, Crespy
L, et al. Improvement of spasticity following intermittent
theta burst stimulation in multiple sclerosis is associated
with modulation of resting-state functional connectivity of
the primary motor cortices. Mult Scler. 2017;23(6):855-63.
doi: 10.1177/1352458516661640
Oliveira EML, Souza NA. Esclerose Múltipla. Rev Neuro.
;6(3):114-8. doi: 10.34024/rnc.1998.v6.1032
Khan F, Amatya B, Bensmail B, Yelnik A. Non-pharmacological
interventions for spasticity in adults: An overview of
systematic reviews. Ann Phys Rehabil Med. 2019;62(4):265-73.
doi: 10.1016/j.rehab.2017.10.001
Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer
TL. Prevalence and treatment of spasticity reported by
multiple sclerosis patients. Mult Scler. 2004;10(5):589-95.
doi: 10.1191/1352458504ms1085oa
Lance JW. What is spasticity? The Lancet. 1990;335(8689):606.
doi: 10.1016/0140-6736(90)90389-m
Kheder A, Nair KPS. Spasticity: pathophysiology, evaluation
and management. Pract Neurol. 2012;12(5):289-98. doi: 10.1136/
practneurol-2011-000155
Teixeira LF, Olney SJ, Brouwer B. Mecanismos e medidas de
espasticidade. Fisioter Pesqui. 2011;5(1):4-19. doi: 10.1590/
fpusp.v5i1.76781
Abbruzzese G. The medical management of spasticity. Eur J Neurol.
;9(Suppl 1):30-4. doi: 10.1046/j.1468-1331.2002.0090s1030.x
Rekand T, Grønning M. Treatment of spasticity related to
multiple sclerosis with intrathecal baclofen: a long-term followup.
J Rehabil Med. 2011;43(6):511-4. doi: 10.2340/16501977-0811
Fletcher SG, Castro-Borrero W, Remington G, Treadaway K,
Lemack GE, Frohman EM. Sexual dysfunction in patients with
multiple sclerosis: a multidisciplinary approach to evaluation
and management. Nat Clin Pract Urol. 2009;6(2):96-107.
doi: 10.1038/ncpuro1298
Centonze D, Koch G, Versace V, Mori F, Rossi S, Brusa L, et al.
Repetitive transcranial magnetic stimulation of the motor
cortex ameliorates spasticity in multiple sclerosis. Neurology.
;68(13):1045-50. doi: 10.1212/01.wnl.0000257818.16952.62
Mori F, Ljoka C, Magni E, Codecà C, Kusayanagi H, Monteleone
F, et al. Transcranial magnetic stimulation primes the effects of
exercise therapy in multiple sclerosis. J Neurol. 2011;258(7):1281-7.
doi: 10.1007/s00415-011-5924-1
Mori F, Codecà C, Kusayanagi H, Monteleone F, Boffa L,
Rimano A, et al. Effects of intermittent theta burst stimulation
on spasticity in patients with multiple sclerosis. Eur J Neurol.
;17(2):295-300. doi: 10.1111/j.1468-1331.2009.02806.x
Hugos CL, Cameron MH. Assessment and measurement of
spasticity in MS: State of the evidence. Curr Neurol Neurosci
Rep. 2019;19(10):79. doi: 10.1007/s11910-019-0991-2
Şan AU, Yılmaz B, Kesikburun S. The Effect of Repetitive
Transcranial Magnetic Stimulation on Spasticity in Patients with
Multiple Sclerosis. J Clin Neurol. 2019;15(4):461-7. doi: 10.3988/
jcn.2019.15.4.461.
Di Lazzaro V, Profice P, Pilato F, Dileone M, Oliviero A, Ziemann
U. The effects of motor cortex rTMS on corticospinal descending
activity. Clin Neurophysiol. 2010;121(4):464-73. doi: 10.1016/j.
clinph.2009.11.007
Suppa A, Ortu E, Zafar N, Deriu F, Paulus W, Berardelli A, et al.
Theta burst stimulation induces after-effects on contralateral
primary motor cortex excitability in humans. J Physiol.
;586(18):4489-500. doi: 10.1113/jphysiol.2008.156596
Watanabe T, Hanajima R, Shirota Y, Ohminami S, Tsutsumi R,
Terao Y, et al. Bidirectional effects on interhemispheric
resting-state functional connectivity induced by excitatory
and inhibitory repetitive transcranial magnetic stimulation.
Hum Brain Mapp. 2014;35(5):1896-905. doi: 10.1002/hbm.22300
Di Lazzaro V, Pilato F, Dileone M, Profice P, Oliviero A, Mazzone
P, et al. The physiological basis of the effects of intermittent
theta burst stimulation of the human motor cortex. J Physiol.
;586(16):3871-9. doi: 10.1113/jphysiol.2008.152736
Su D, Wang A, Zhu M, Yang F, Li W, Ma B, et al. Repetitive
transcranial magnetic stimulation for treatment of limb
spasticity following multiple sclerosis: a systematic review
and meta-analysis. Braz J Med Biol Res. 2003;56:e12708.
doi: 10.1590/1414-431X2023e12708
Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmöller J,
et al.. Safety and recommendations for TMS use in healthy
subjects and patient populations, with updates on training, ethical
and regulatory issues: Expert Guidelines. Clin Neurophysiol.
;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003
Ahdab R, Ayache SS, Brugières P, Farhat WH, Lefaucheur JP.
The hand motor hotspot is not always located in the hand knob:
a neuronavigated transcranial magnetic stimulation study. Brain
Topogr. 2016;29(4):590-7. doi: 10.1007/s10548-016-0486-2
Klem GH, Lüders HO, Jasper HH, Elger C. The ten-twenty
electrode system of the International Federation. International
Federation of Clinical Neurophysiology. Electroencephalogr
Clin Neurophysiol Suppl. 1999;52:3-6.
Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development
of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000;10(5):361-74.
doi: 10.1016/s1050-6411(00)00027-4
Ashworth B. Preliminary Trial of Carisoprodol in Multiple
Sclerosis. Practitioner. 1964;192:540-2.
Bajd T, Vodovnik L. Pendulum testing of spasticity. J Biomed
Eng. 1984;6(1):9-16. doi: 10.1016/0141-5425(84)90003-7
Fagius J, Wallin BG, Sympathetic reflex latencies and conduction
velocities in normal man. J Neuro Sci. 1980;47(3):433-48.
doi: 10.1016/0022-510X(80)90098-2
Penn RD, Savoy SM, Corcos D, Latash M, Gottlieb G,
Parke B, et al. Intrathecal baclofen for severe spinal
spasticity. N Engl J Med. 1989;320(23):1517-21. doi: 10.1056/
NEJM198906083202303.
Farrar JT, Troxel AB, Stott C, Duncombe P, Jensen MP. Validity,
reliability, and clinical importance of change in a 0-10 numeric
rating scale measure of spasticity: a post hoc analysis of a
randomized, double-blind, placebo-controlled trial. Clin Ther.
;30(5):974-85. doi: 10.1016/j.clinthera.2008.05.011
Buysse DJ, Reynolds Third CF, Monk TH, Berman SR, Kupfer
DJ. The Pittsburgh Sleep Quality Index: a new instrument
for psychiatric practice and research. Psychiatry Res.
;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4
Downloads
Published
Issue
Section
License
Copyright (c) 2024 Fernanda Ishida Corrêa, Amanda Cristina da Silva Reis, Bruno Paulino Venâncio, João Carlos Ferrari Corrêa
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
