Apparatus for the controlled prescription and administration of transcranial direct current stimulation treatments in humans
First Claim
1. A system to control the process of prescription and administration of electrical direct current stimulation treatments for neuromodulation of nervous tissue, the system comprising:
- a. at least two electrodes adapted to be applied externally on the skin of a subject;
b. at least one stimulating device adapted to be provided externally to the subject for administration of electrical current stimulation treatment, wherein the at least one stimulating device is connected to the at least two electrodes;
c. a control device connected to the at least one stimulating device through an unsafe communication channel;
wherein the at least one stimulating device is enabled by said subject to stimulation treatment delivery only according to modalities defined in a prescription made by a specialized subject and only after having received from the control device a positive result of a verification of a credential of the specialized subject who is making the prescription, wherein the prescription is defined as a finite number of stimulations with a specific minimum time interval between two consecutive stimulations,and wherein the at least one stimulating device is not activated by said subject for a new stimulation treatment delivery when the finite number of stimulations is reached for the current stimulation treatment or until the specific minimum time interval between two consecutive stimulation treatments is fully elapsed, thus preventing the subject to make unscheduled stimulation treatments,and wherein the at least one stimulating device comprises a start button pushed by said subject to start the stimulation, wherein said start button remains inactive until the fixed interval between two consecutive stimulations is fully elapsed.
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Abstract
The invention proposes a system and a method for controlling the process of prescription and administration of direct current stimulation treatments in humans. In the proposed system, the stimulation parameters are all set by a specialist whose credentials are verified through a specific control device different from the device that delivers electrical stimulation. The stimulating device can deliver the stimulation only if the credentials of the specialized subject making the prescription are verified and if the prescription is made according to safety criteria. The system is composed by at least one device for the administration of electrical current connected to two electrodes applied over the skin and by a control device. The control device is connected to one or more devices for the administration of the direct current through a communication channel. The specialist gives his own credentials and is authorized at making the prescription and, accordingly, programming the stimulating device. The prescription defines the stimulus intensity, waveform, polarity, duration, the minimum interval between two consecutive stimulations and the maximum number of stimulations allowed. The stimulating device delivers the stimulation only if the credentials of the specialist are verified and only according to the prescription.
32 Citations
21 Claims
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1. A system to control the process of prescription and administration of electrical direct current stimulation treatments for neuromodulation of nervous tissue, the system comprising:
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a. at least two electrodes adapted to be applied externally on the skin of a subject; b. at least one stimulating device adapted to be provided externally to the subject for administration of electrical current stimulation treatment, wherein the at least one stimulating device is connected to the at least two electrodes; c. a control device connected to the at least one stimulating device through an unsafe communication channel; wherein the at least one stimulating device is enabled by said subject to stimulation treatment delivery only according to modalities defined in a prescription made by a specialized subject and only after having received from the control device a positive result of a verification of a credential of the specialized subject who is making the prescription, wherein the prescription is defined as a finite number of stimulations with a specific minimum time interval between two consecutive stimulations, and wherein the at least one stimulating device is not activated by said subject for a new stimulation treatment delivery when the finite number of stimulations is reached for the current stimulation treatment or until the specific minimum time interval between two consecutive stimulation treatments is fully elapsed, thus preventing the subject to make unscheduled stimulation treatments, and wherein the at least one stimulating device comprises a start button pushed by said subject to start the stimulation, wherein said start button remains inactive until the fixed interval between two consecutive stimulations is fully elapsed. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification