Will this cure spasticity? That is the only endpoint for spasticity research! NOTHING LESS!
A Randomized Controlled Trial to Test the Effects of Repetitive Peripheral Magnetic Stimulation Versus Neuromuscular Electrical Stimulation in Patients with Spastic Hemiparesis After Stroke (REPMAST): Study Protocol
Kristin Loreen Pohl
1
Section of Neurological Rehabilitation, Clinic of Neurology, Jena University Hospital, 07747 Jena, Germany
2
Department of Neurology, Gräfliche Kliniken Moritz Klinik GmbH, 07639 Bad Klosterlausnitz, Germany
*
Author to whom correspondence should be addressed.
Brain Sci. 2024, 14(12), 1249; https://doi.org/10.3390/brainsci14121249
Submission received: 28 October 2024
/
Revised: 3 December 2024
/
Accepted: 11 December 2024
/
Published: 12 December 2024
(This article belongs to the Special Issue New Studies on Stroke Care and Rehabilitation)
Abstract
Background/Objectives:
Innovative
therapies are needed to reduce disability, facilitate activities of
daily living, and improve the quality of life(Survivors want full recovery, NOT JUST IMPROVEMNT; Don't you ever talk to survivors without justifying your failures by parroting the tyranny of low expectations?)in patients with stroke.
Non-invasive methods of stimulating the peripheral and central nervous
system are increasingly being used to enhance the effects of existing
therapies in stroke rehabilitation. One potentially relevant method for
achieving greater improvement is repetitive peripheral magnetic
stimulation (rPMS). This randomized controlled trial (RCT), the
Peripheral MAgnetic stimulation in patients with spastic hemiparesis
after Stroke Trial (REPMAST), will investigate whether rPMS improves
upper extremity function, spasticity, and activities of daily living in
patients with stroke compared with neuromuscular stimulation (NMS).
Methods:
REPMAST is an interventional, randomized controlled
single-blinded study. Patients with subacute stroke are randomized to
receive rPMS or NMS five days a week for three weeks in addition to
standard rehabilitation therapy. The primary outcome is the change in
the Fugl–Meyer Assessment for Upper Extremity between the beginning and
end of the stimulation sessions. Secondary outcomes include changes in
the Katz Index of Independence in Activities of Daily Living, the Timed
Up and Go Test, the Modified Ashworth Scale, and the Tardieu Scale. A
total sample size of 138 patients (69 in each group) is required to
investigate the superiority of rPMS compared with NMS.
Conclusions:
The
aim of this RCT is to provide evidence for an effective(Effective to a survivor is curing spasticty! Will this do that?) peripheral
stimulation treatment for stroke recovery.
1. Introduction
Stroke is the third leading cause of death and disability combined worldwide [1].
Innovative therapies are needed to reduce disability, facilitate
activities of daily living (ADL), and improve quality of life [2].
In
recent years, in addition to physiotherapy and occupational therapy,
non-invasive brain stimulation methods such as transcranial direct
current stimulation and repetitive transcranial magnetic stimulation
(rTMS) have been increasingly used to modulate brain function in order
to improve functional deficits after stroke.
Another possibility to modulate brain function is through peripheral application, such as peripheral electrical stimulation [3,4] or with the use of repetitive peripheral magnetic stimulation (rPMS) [5,6].
Repetitive peripheral magnetic stimulation (rPMS) is a painless
stimulation method that uses rapidly changing magnetic fields to
stimulate peripheral nerves and trigger repeated contractions of the
skeletal muscles. Using rPMS is simple compared with other NIBS
approaches. The stimulation coil is placed directly on the skin in the
area of the target muscle to be stimulated. The magnetic field
penetrates the tissue and causes depolarization due to the electric
field that builds up, resulting in the induction of an action potential,
which clinically leads to muscle contraction. The rPMS method has also
been used to stimulate peripheral nerves or spinal nerve roots, with the
stimulation coil placed paravertebrally or over the corresponding nerve
[7,8,9,10].
The exact mechanism of how rPMS interacts with the central and
peripheral nervous systems is not yet fully understood. Struppler and
colleagues suggested that rPMS causes increased proprioceptive input to
the brain by activating mechanoreceptors of the contracted muscle [11].
Another type of input has been suggested to come directly from the
nerve fibers. Consequently, rPMS increases sensory input from the
affected limb to the brain, initiating neuroplastic processes and
leading to improved sensorimotor performance in patients.
In
the 1990s, the first studies by Struppler and colleagues reported
improvements in perception, spasticity, and paresis after stroke and in
patients with multiple sclerosis following the use of rPMS [12,13,14]. Over the past decade, the number of studies using rPMS has increased significantly [15].
Recent meta-analyses have reported that rPMS induces a better
Fugl–Meyer Assessment for Upper Extremity (FMAUE) compared with control
groups [16,17]. However, it has also been criticized that there is a lack of rPMS studies conducted as RCTs with large sample sizes [18,19,20].
Therefore, the current randomized controlled trial, the Repetitive
Peripheral Magnetic stimulation in patients with spastic hemiparesis
after Stroke Trial (REPMAST), will investigate the effect of rPMS
compared to neuromuscular stimulation (NMS) in a large sample of
patients with stroke. Because of the sensory influence of rPMS on the
brain, the effect of rPMS in REPMAST will be compared with that of a
control group that receives neuromuscular stimulation (NMS).
Previous reports have compared the advantages and disadvantages of rPMS and NMS [5,6,21]. It is important to note that although both interventions stimulate some common peripheral structures [6],
they nevertheless activate different networks. Repetitive PMS has been
found to increase activation of the ipsilesional superior posterior
parietal and premotor cortex [11]. By contrast, NMS has been described to increase activity in the ipsilesional sensorimotor cortex [22]. Recent clinical studies have compared rPMS over muscles with sham [23], standard care [21], conventional physiotherapy [24], or its combination with low-frequency rTMS [10].
REPMAST is a randomized controlled comparative interventional trial
that aims to investigate the efficacy (superiority) of rPMS compared
with NMS in a large number of patients with subacute stroke, as there is
no direct comparison between rPMS and NMS.
There are conflicting results regarding the effectiveness of rPMS in improving spasticity [14,16,18,19,20,23]. Therefore, this study will also analyze the effect of rPMS on spasticity.
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