APPARATUS FOR THE CONTROLLED PRESCRIPTION AND ADMINISTRATION OF TRANSCRANIAL DIRECT CURRENT STIMULATION TREATMENTS IN HUMANS

• US 20110118809A1
• Filed: 06/10/2009
• Published: 05/19/2011
• Est. Priority Date: 06/12/2008
• Status: Active Grant

• Current Assignee: Laura Bertolasi, Lorenzo Rossi, Sara Renata Francesca Marceglia, Simona Mrakic-Sposta
• Original Assignee: Laura Bertolasi, Lorenzo Rossi, Sara Renata Francesca Marceglia, Simona Mrakic-Sposta
• Inventors: Rossi, Lorenzo, Marceglia, Sara Renata Francesca, Mrakic-Sposta, Simona, Bertolasi, Laura
• Granted Patent: US 9,026,216 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3603 Control systems
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network

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.

Claims

1. A system for neuromodulation of human nervous tissue through direct current stimulation comprising:

a. at least two electrodes (109, 110) applied on the skin of a human subject;

b. at least one device for the administration of electrical current (101) connected to the two electrodes (109, 110);

c. a control device (100) connected to one or more devices for the administration of the direct current (101) through a communication channel (108) also supposed unsafe;

wherein the device for electrical current administration (101) is enabled to treatment delivery (102) only according to the modalities defined in a prescription (105) made by a specialized subject (103) and only after having received from the control device (100) a positive result (107) of the verification of the credentials (106) of the subject who is making the prescription (103).

2. A system as claimed in claim 1 further comprising a device for electrical current administration (101) that is not enabled at delivering a treatment different from that defined in the prescription (105).

3. A system as claimed in claim 1 further comprising a device for electrical current administration (101) that is not enabled at delivering a treatment without receiving a positive result from the credential verification process (107) carried out by the control device (100) and transmitted through a channel that can be considered also unsafe (108).

4. A system as claimed in claim 1 further comprising a prescription (200) defined as a finite number of stimulations (201) with a specific minimum time interval (202) between two consecutive stimulations.

5. A system as claimed in claim 4 wherein each stimulation (201) is defined by parameters such as stimulus intensity, stimulus waveform (constant current or randomized current with a given mean value), stimulus polarity (anodal, cathodal, or sham), stimulation duration.

6. A system as claimed in claim 4 wherein the minimum time interval (202) elapsing between two consecutive stimulations can be directly defined either indicating the number of treatments per day/week/month, or indicating the dates on a calendar.

7. A system as claimed in claim 1 further comprising a stimulating device (300) that includes two modules, connected through a dedicated cable (308), one containing the technology for stimulus delivery (309), and the other one (306) representing the interface between the device (300) and both the subject making the prescription (318) and the technology for data transmission (302).

8. A system as claimed in claim 7 further comprising an interface module (306) composed by an input device (305) and by a telecommunication interface TCP/IP (307).

9. A system as claimed in claim 7 further comprising a stimulating device (300) that receives the prescription (303), and an alpha-numeric code (304) through an input device (305).

10. A system as claimed in claim 9 further comprising an input device (305) implemented through a touch screen monitor.

11. A system as claimed in claim 7 further comprising a module for treatment administration (309) including a programmable stimulator (310) and a patient interface (311).

12. A system as claimed in claim 11 further comprising a patient interface (311) implemented as a start button for activating a prescribed stimulation (201).

13. A system as claimed in claim 7 further comprising a module for treatment administration (309) that verifies whether the stimulation delivered is correct monitoring the difference of electrical potential between the two electrodes.

14. A system as claimed in claim 1 where the stimulating device (300) and the control device (301) are connected through the Internet (302) using the TCP/IP telecommunication standard.

15. A system as claimed in claim 1 where the control device (301) is implemented through a server that receives data according to the TCP/IP standard and that contains a knowledge base (315) with all the active credentials.

16. A system as claimed in claim 15 further comprising a stimulating device (300) that includes two modules, connected through a dedicated cable (308), one containing the technology for stimulus delivery (309), and the other one (306) representing the interface between the device (300) and both the subject making the prescription (318) and the technology for data transmission (302), where the stimulating device (300) and the control device (301) are connected through the Internet (302) using the TCP/IP telecommunication standard

wherein the data transmission between the control device (301) and the stimulating device (300) is encrypted through a public key system with asymmetric encrypting algorithms.

17. A system as claimed in claim 16 further comprising a stimulating device (300) where at least its public key (312), its private key (316), and the public key of the control device (313) are stored when the device is manufactured.

18. A system as claimed in claim 16 where the stimulating device encrypts the alpha-numeric code (304) received with the prescription and its public key (312) with the public key (313) of the control device (301) and it transmits the encrypted package to the control device (301), that decrypts the package through its secret key (314) and sends the result of the verification process encrypted through the public key (312) of the stimulating device (300) to the stimulating device (300) itself that decrypts the received data through its private key (316).

19. A system as claimed in claim 18 where the encrypted data packages are converted to the standard TCP/IP and sent to the IP address where the control device (301) can be found.

20. A system as claimed in claim 15 wherein the stimulating device (300) and the control device (301) are connected through the Internet (302) using the TCP/IP telecommunication standard and the credentials (304) of the subject making the prescription (318) are obtained and verified by querying a knowledge base (315) that contains all the active credentials and that is included in the control device.

21. A system as claimed in claim 15 where the stimulating device (300) and the control device (301) are connected through the Internet (302) using the TCP/IP telecommunication standard and the stimulating device (300) checks the result of the authentication process before programming the stimulation according to the prescription received (305).

22. A system as claimed in claim 15 wherein the stimulating device (300) and the control device (301) are connected through the Internet (302) using the TCP/IP telecommunication standard and further comprising a start button (311) that remains inactive until the fixed interval between two consecutive stimulations (202) is fully elapsed.

23. A system as claimed in claim 15 wherein the stimulating device (300) and the control device (301) are connected through the Internet (302) using the TCP/IP telecommunication standard and the knowledge base (315) where all the active credentials are stored and included in the control device (301) is kept secret to the subjects who could receive the stimulation or who could prescribe the treatment.