Más contenido relacionado La actualidad más candente (13) Más de Painezee Specialist (20) Zmpczm017000.06 Clinical data report NeuroMove1. •
Zynex Medical NeuroMove 900
EMG‐Triggered Neuromuscular Electrical Stimulation Device
Clinical Data Literature Review
• Purpose of this Review
This report is an analysis and summary of literature reviewed for the Zynex Medical NeuroMove 900
Neuromuscular Electrical Stimulation Device (NMES) family in accordance with MDD 93/42/EEC as
amended by Directive 2007/47/EC Annex X, Literature Review Route requirements; specifically, the
Zynex Medical NeuroMove 900 Neuromuscular Electrical Stimulation Device (NMES) .
As a general rule, confirmation of conformity with the requirements concerning the characteristics and
performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the
device, and the evaluation of the side‐effects and of the acceptability of the benefit/risk ratio referred to
in Section 6 of Annex I, must be based on clinical data. The evaluation of this data hereinafter referred
to as “clinical evaluation”, where appropriate taking account of any relevant harmonized standards must
follow a defined and methodologically sound procedure based on:
Either a critical evaluation of the relevant scientific literature currently available relating to the
safety, performance, design characteristics, and intended purpose of the device where:
•
There is demonstration of equivalence of the device to the device to which the data relates,
and
•
The data adequately demonstrate compliance with the relevant essential requirements.
•
Or a critical evaluation of the results of all clinical investigations made.
•
Or a critical evaluation of the combined clinical data provided in 1 and 2.
This analysis is based on relevant scientific literature currently available relating to the NeuroMove 900
EMG‐Triggered NMES device in the aspects of safety, performance, design characteristics, and intended
purpose. The literature reviewed was based on a demonstration of equivalence of the device to the
device(s) that we have in place in the market.
Description of the Device:
The NeuroMove 900 (NM) device is designed to be easy to operate and to be utilized in the home as an
adjunct to other therapies. The NM is based on the Pavlov’s Dog theory that repetition and reward for
attaining a goal can retrain the brain.
6. Based on (i) equivalence of the intended use, (ii) method of application in the body, (iii) similar patient
population, and (iv) critical performance necessary to achieve the expected clinical effect, the clinical
characteristic of the NeuroMove 900 device is equivalent to the predicate AutoMove 800 device.
Technical equivalence
The NeuroMove 900 has the same or similar technical characteristic as other referenced emg‐triggered
muscle stimulation devices.
The key aspects of the NeuroMove 900 design are also found in the equivalent devices. All of the emg‐
triggered stimulation devices work by attaching non‐invasive electrode pads over the muscle and setting
a stimulation level (mA) to see visible movement of the muscle and feel the stimulation. The specific
geometry of the NM 900 device is comparable to all of the predicate devices.
Based on similarities in the basic design features, geometry, size, shape, materials and strength, and the
conditions of use, the technical characteristics of the NM 900device are substantially similar to the
predicate devices.
Also, mechanical testing demonstrates comparable mechanical properties to predicate devices. Thus,
the NeuroMove 900 device is substantially equivalent to predicate devices.
Assessment of clinical data
Based on the critical evaluation of the literature, there is a substantial body of evidence to support
efficacy of equivalent devices for the indications and type of applications claimed for emg‐triggered
electrical stimulation, evidence supports efficacy of emg‐triggered electrical stimulation for stroke,
spinal cord injury, traumatic brain injury, increased movement, increased hand/wrist movement,
increased dorsiflexion, increased elbow movement, increased shoulder movement and to decrease
muscle spasms.
Overall, there is a support for favorable benefit for the NeuroMove 900 device based on the review
overview of clinical outcomes for equivalent devices.
Critical evaluation of the literature
Critical evaluation of the literature has been performed by Tara Miller, Clinical Development; Jim Arnold,
Manager Quality and Regulatory Affairs; and Bob Cozart, Vice President, Technical Operations.
•
CHRONIC MOTOR DYSFUNCTION
Stroke is the number one cause of functional disability in this country with approximately 795,000
strokes occurring annually. Voluntary movement control is typically impaired after a stroke. The specific
neurological mechanisms that mediate neuromuscular recovery are still not understood. Evidence
suggests that some motor recovery occurs because the auxiliary cortex areas may take over some
functions.
Efficacy
The purpose to determine the effect of emg‐triggered electrical stimulation on wrist and extensor
muscles in individuals post stroke ≥ 1 year. (Cauraugh J, 2000)
7.
Investigators suggest that the benefit in these studies stems from proprioceptive afferent feedback that
accompanies motor stimulation as it is well known that afferent input affects motor centers at the spinal
and supraspinal levels. (Kimberley TJ, 2002 )
In a controlled, double blind study design, Kimberly et al studied the effect of intensive in home NMES
treatments in 16 post stroke survivors for 60h/3 weeks compared to sham treatment. The findings show
that NMES may play an important role in stimulating cortical sensory areas to allow for improved motor
function. (Kimberely TJ, 2004)
Results
Eleven individuals voluntarily participated and were randomly assigned to emg‐triggered stimulation
group (7 subjects) or the control group (4 subjects). The block and box test and force‐generation task
(sustained muscular contraction) revealed significant findings (P<0.05). The experimental group moved
more blocks and displayed higher isometric force impulse after rehab treatments. (Cauraugh J, 2000)
In a pilot, randomized, single blinded trial, nine subjects were assessed for upper extremity Fugl‐Meyer
motor assessment and the feeding, grooming and upper body dressing items of the FIM at entry and at
discharge. The subjects treated with emg‐triggered stimulation demonstrated greater gains in Fugl‐
Meyer (27.0 vs 10.4; p = .05) and FIM (6.0 vs 3.4; p = .02). Data suggests that the emg‐triggered
electrical stimulation increases arm function for stroke survivors. (Francisco G, 1998)
COUPLED MOTOR RECOVERY
Efficacy
Studies investigating the use of both emg‐triggered electrical stimulation and bilateral coordination
together provide evidence that coupled protocols might assist patients to expand their motor skills
further. In a randomized study including 25 stroke survivors assigned to 0ne of three groups: 1) coupled
protocol and bilateral movement (n=10), emg‐triggered electrical stimulation and unilateral movement
(n=10) and 3) control (n=5), motor capabilities were evaluated on the basis of three categories of motor
tasks in a pre and post test design. Significant findings for the three groups favored coupled emg‐
triggered electrical stimulation and coupled bilateral movement training. (Cauraugh JH K. S., 2002)
Results
Evidence demonstrates a significant decrease in hemiparegic wrist and fingers for post CVA patients.
The coupled protocol group was able to achieve increase in voluntary controls across the three
categories of tasks. (Cauraugh JH K. S., 2002)
Combination of coupled protocols with emg‐triggered electrical stimulation and bilateral coordination
movement produce intralimb transfer evidence for distal practice and proximal joint combination
benefits. (Cauraugh JH K. S., 2005)
10. Signature Page
I confirm that I have conducted and supervised the process of the Clinical Evaluation for the NeuroMove
900 emg‐triggered electrical muscle stimulation device.
Based on (i) equivalence of the intended use, (ii) method of application in the body, (iii) similar patient
population, and (iv) critical performance necessary to achieve the expected clinical effect, the clinical
characteristics of the NeuroMove 900 devices are equivalent to the other emg‐triggered stimulation
devices.
In considering the risks of the use of emg‐triggered electrical muscle stimulation devices identified,
NeuroMove 900, as well as in this clinical literature based evaluation, versus the benefits of its use, the
benefits of its use clearly outweigh the risks when applied according to established indications and
instructions for use.
Tara Miller
Clinical Development
Jim Arnold
Manager, Quality Assurance
Bob Cozart
Vice President, Technical
Operations
Reference List
Cauraugh J, L. K. (2000). Chronic Motor Dysfunction After Stroke Recovering Wrist and Finger Extension
by Electromyography‐Triggered Neuromuscular Stimulation. Stroke , 1360‐1364.
Cauraugh JH, K. S. (2005). Coupled Bilateral Movements and Active Neuromuscualr Stimulation:
Intralimb Transfer evidence During Bimanual Aiming. Neuroscience Letters , 39‐44.
Cauraugh JH, K. S. (2002). Two Coupled motor Recovery Protocols Are Better Than One Electromyogram‐
Triggered Neuromuscular Stimulation and Bilateral Movements. Stroke , 1589‐1594.
Francisco G, C. J. (1998). Electromyogram‐Triggered Neuromuscular Stimulation for Improving the Arm
Function of Acute Stroke Survivors: A Randomized Pilot Study. Arch Phys Med Rehabil , 570‐575.
Kimberely TJ, L. S. (2004). Electrical Stimulation Driving Functional Improvements and Cortical Changes
in Subjects with Stroke. Exp Brain Res , 450‐460.
Kimberley TJ, C. J. (2002 ). Neuromuscular Electrical Stimulation in Stroke Rehabilitation. Minnesota
Medical Association , 45‐48.