Electrical current generator device for use in the treatment of motor disorders, sensitive disorders and pain (Machine-translation by Google Translate, not legally binding)

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ELECTRIC CURRENT GENERATING DEVICE FOR USE IN THE

TREATMENT OF MOTOR DISORDERS, SENSITIVE DISORDERS AND PAIN

DESCRIPTION

FIELD OF THE INVENTION

The technical field of the present invention is electromedicine. Specifically, the technical field refers to electrical current generating devices for therapeutic purposes. The therapeutic purpose is the treatment of motor disorders, sensory disorders and pain.

BACKGROUND OF THE INVENTION

Within the field of physiotherapy, physical medicine and rehabilitation, more specifically in the application of electrical currents for therapeutic purposes, the frequencies currently used are less than 10 KHz and also interrupted or modulated (Nemec Interferential Currents, Russian Stimulation and Aussie currents) (Fig. 1).

DESCRIPTION OF THE INVENTION

The technical problem in view of the closest state of the art can be defined as the provision of an alternative electric current generating device for use in the treatment of motor disorders, sensory disorders and pain.

The solution to this problem consists in providing the electric current generating device defined by the claims of the present patent application.

In a first aspect, the present invention provides an electrical current generator device for use in the treatment of motor disorders, sensory disorders and pain, comprising a current intensity selector, a milliammeter and terminal posts for electrical current output, characterized because the current generated by the device is uninterrupted, with a frequency between 10 and 50 KHz, with a pulse width between 20 and 100 ps and with a current intensity between 1 and 200 mA.

A second aspect is the device according to the first aspect of the invention, which comprises a skin impedance or resistance indicator.

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A third aspect is the device according to the first aspect of the invention, where the waveform of the alternating current is sinusoidal or rectangular.

According to the third aspect of the invention, two selectable waveforms can be selected in the device: sinusoidal alternating and rectangular alternating (Fig. 2). The rectangular alternating waveform has shown a lower blocking threshold in preclinical studies in animals than the sinusoidal one.

In the first, second or third aspect of the invention, the electric current generated by the device does not present interruptions or modulations, the flow being uninterrupted.

In the first, second or third aspect of the invention, the pulse width of the electric current is variable as a function of frequency. The pulse width of the electric current is selected between 20 ps at 50 KHz and 100 ps at 10 KHz.

In the first, second or third aspect of the invention, the intensity of the electric current is selectable between 1 and 200 mA with two options, Constant Current (CC) or Constant Voltage (CV) (between 100-250 V).

In the first, second or third aspect of the invention, a current density calculation (mA / cm²) depending on the size of electrodes applied.

In the first, second or third aspect of the invention, the device comprises a power cable outlet, to connect the device to the electrical network.

In the first, second or third aspect of the invention, the device comprises terminal posts (5) to connect 2 mm diameter cables for current output of the patient-equipment.

In the first, second or third aspect of the invention, the duration of the electric current can be selected between 1 and 60 minutes with a timer or the electric current can be generated indefinitely. The electrical current would only be interrupted by lowering the intensity or turning off the equipment.

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Another aspect is the device according to the first, second or third aspect of the invention, where the motor disorder is spasticity, dystonia or tremors.

The neuromodulation produced by the alternating current generated by the device of the first, second or third aspect of the invention is rapidly reversible after application and does not cause tissue damage to the tissues. Studies in humans carried out in the present invention have evidenced the safety of the application and have demonstrated transient and rapidly reversible neurophysiological modifications in nerve conduction, without producing morphological alterations or undesirable effects on stimulated tissues.

In the studies carried out in the present invention, no adverse effect has been evidenced, so it can be considered that the neuromodulation produced by the alternating current generated by the device of the first aspect of the invention is a safe application.

The alternating current generated by the device of the first, second or third aspect of the invention presents differential effects with respect to the interrupted currents used in the state of the art. Specifically, while the interrupted currents emitted by other devices cause the depolarization of the nervous system, generating motor and sensory action potentials, the alternating current generated by the device of the first or second aspect of the invention produces the opposite effect, blocking the conduction of action potentials. , this blocking being transitory and reversible once the current ceases. In this way, the present invention is of great therapeutic interest in pathologies characterized by hyperactivity of the nervous system, such as spasticity or chronic pain, which have a high prevalence.

The alternating current generated by the device of the first, second or third aspect of the invention has a great potential for application in treatment centers for motor and / or sensory disorders. They can also be applied to the field of study and research in neurophysiology, since the selective blocking of certain types of nerve fibers facilitates the analytical study of others.

BRIEF DESCRIPTION OF THE FIGURES

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Figure 1. Graphic representation (intensity / time) of Interference Currents! Es (a), Russian Currents (b) and Aussie Currents (c) emitted by other devices. All of them present interruptions or modulations of the current and also present a frequency lower than 10KHz.

Figure 2. Graphic representation (intensity / time) of the waveform used in the invention. At the top it alternates sinusoidal and at the bottom it alternates rectangular.

Figure 3. Scheme of a device that generates electric currents.

Figure 4. Normalized effect of stimulation with alternating sinusoidal electrical currents 10 and 20 KHz according to the invention applied on the median and ulnar nerve, compared with another current considered a reference standard (TENS current) and placebo stimulation on the motor response (force maximum isometric volunteer). *: p <0.05; ***: p <0.001. Pre: measurement before stimulation; 15min: measurement 15 minutes after stimulation; Post 0: measurement just at the end of stimulation; Post 10: measurement 10 minutes after the end of stimulation. The circles represent the results of placebo stimulation, the squares represent the results with the TENS current, the diamonds represent the results with 10 KHz sinusoidal alternating electric current and the triangles represent the results with 20 KHz sinusoidal alternating electric current.

Figure 5. Normalized effect of stimulation with alternating sinusoidal electric currents 10 and 20 KHz according to the invention applied to the median nerve, compared with placebo stimulation on the pressure pain threshold. *: p <0.05. Pre: measurement before stimulation; 15min: measurement 15 minutes after stimulation; Post 0: measurement just at the end of stimulation; Post 10: measurement 10 minutes after the end of stimulation. The circles represent the results of placebo stimulation, the diamonds represent the results with 10 KHz sinusoidal alternating electric current and the squares represent the results with 20 KHz sinusoidal alternating electric current.

Figure 6. Effect on the maximum H / Maximum M ratio of stimulation with alternating sinusoidal electric currents 10 KHz according to the invention applied transcutaneously at the medullary level, compared with placebo stimulation and another current considered a reference standard (TENS). *: p <0.05. Pre: measurement before stimulation; Dur: measurement 33 minutes after stimulation. Post: measurement 10 minutes after the end of stimulation.

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The circles represent the results of placebo stimulation, the squares represent the results with the TENS current and the diamonds represent the results with 10 KHz sinusoidal alternating electrical currents.

PREFERRED IMPLEMENTATION MODES

Example 1. Example of a generator of uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz

In Fig. 3 a generator of uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz is schematically represented.

The generator comprises:

- screen (1).

- selectors (2) of electric current intensity

- milliammeters (3)

- terminal posts (4) for electrical current output

- outlet (5) of the power cable to the electrical network.

- indicator (6) of skin impedance or resistance (KQ)

On the screen (1) the waveform, the frequency, the output mode (Constant Current (CC) or Constant Voltage (CV)) and the application time (by means of a timer) are selected.

There are two independent current intensity selectors (2), selector for channel 1 and selector for channel 2. The intensity can be selected in steps of 0.1 mA to 10 mA and in steps of 1 mA from from 10 mA to 200 mA.

The milliammeters (3) express the intensity values ​​in absolute values ​​(mA) and in current density (mA / cm²).

The terminal posts (4) have a connection to connect 2 mm diameter cables for the output of current from the equipment to the patient.

Example 2. Clinical trials

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5 Clinical Trials have been carried out, applied in healthy humans, supported by previous basic research with animals. In the five trials, the transcutaneous application of uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz was compared with a current considered a reference standard in transcutaneous application known as TENS (Transcutaneus Electrical Nerve Stimulation) and with placebo stimulation. The location of the electrical stimulation in the different tests was carried out at the level of the peripheral nervous system in the internal popliteal sciatic nerve of the lower limb, the median, radial and ulnar nerves of the upper limb and at the level of the central nervous system in the corresponding spinal metameres S1 and S2 at bone level T10-12.

Studies have shown that the transcutaneous application of uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz in the peripheral nerve path produces a modulation in the motor and sensory response greater than placebo stimulation and the TENS current considered standard. reference. This modulation of nerve activity is of interest in disorders characterized by hyperactivity of the nervous system and which have a high prevalence, such as spasticity and / or chronic pain (Fig. 4 and Fig. 5).

Regarding the spinal application of uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz, the H reflex was measured as a quantification of the excitability of the alpha motor neuron. Its parameters have been used as an indirect indicator of spasticity. Patients with spasticity often have an increased H reflex. In the present invention, a decrease in the H / M ratio was recorded with uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz, without changes in placebo stimulation or in TENS (Fig. 6).

On the other hand, 68.4% (p = 0.023) of the subjects perceived uninterrupted sinusoidal alternating currents with a frequency range between 10 KHz and 50 KHz as more comfortable currents than TENS. Despite the fact that in the former the applied current density was higher.