Adaptive method and apparatus for forecasting and controlling neurological disturbances under a multi-level control

• US 7,146,218 B2
• Filed: 02/04/2003
• Issued: 12/05/2006
• Est. Priority Date: 12/12/2000
• Status: Expired due to Term

• Current Assignee: Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Litt, Brian, Vachtsevanos, George John, Echauz, Javier Ramón, Esteller, Rosana
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/358,039
• Publication Number:
  US 20030158587A1
• Time in Patent Office: 1,400 Days
• Field of Search: 607/45, 600/544, 600/509, 600/519, 600/301, 600/308, 600/398, 600/408, 600/412, 128/898
• US Class Current: 607/45
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• CPC Class Codes: A61B 5/375 using biofeedback
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7267 involving training the classification device
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: G06F 2218/08 Feature extraction
• CPC Class Codes: G16H 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A method and apparatus for forecasting and controlling neurological abnormalities in humans such as seizures or other brain disturbances. The system is based on a multi-level control strategy. Using as inputs one or more types of physiological measures such as brain electrical, chemical or magnetic activity, heart rate, pupil dilation, eye movement, temperature, chemical concentration of certain substances, a feature set is selected off-line from a pre-programmed feature library contained in a high level controller within a supervisory control architecture. This high level controller stores the feature library within a notebook or external PC. The supervisory control also contains a knowledge base that is continuously updated at discrete steps with the feedback information coming from an implantable device where the selected feature set (feature vector) is implemented. This high level controller also establishes the initial system settings (off-line) and subsequent settings (on-line) or tunings through an outer control loop by an intelligent procedure that incorporates knowledge as it arises. The subsequent adaptive settings for the system are determined in conjunction with a low-level controller that resides within the implantable device. The device has the capabilities of forecasting brain disturbances, controlling the disturbances, or both. Forecasting is achieved by indicating the probability of an oncoming seizure within one or more time frames, which is accomplished through an inner-loop control law and a feedback necessary to prevent or control the neurological event by either electrical, chemical, cognitive, sensory, and/or magnetic stimulation.

Claims

1. A system for predicting and controlling the electrographic and clinical onset of a seizure and other neurological disturbances in an individual, comprising:

a data generation component to acquire physiological signals from the individual;

an intelligent data processing unit to preprocess the physiological signals, to extract and select a plurality of features, and to provide an estimation of the probability of seizure for at least one specific time frame; and

a low level controller connected to the intelligent data processing unit to automatically activate a preventive therapeutic intervention measure to control the onset of a seizure in the individual in response to the probability of seizure for at least one specific time frame exceeding a threshold.

2. The system for predicting and controlling the electrographic onset of a seizure of claim 1 further comprising at least one sensor for detecting physiological signals that indicate the state of activity in the brain of the individual.

3. The system for predicting and controlling the electrographic onset of a seizure of claim 2 wherein the sensor is at least one of an implanted intracranial electrode, an epidural electrode, a scalp electrode, a sphenoidal electrode, a foramen ovale electrode, an intravascular electrode, a chemical sensor, a pupil dilation sensing device, an eye movement sensor, a heart rate sensor, and a body temperature sensor.

4. The system for predicting and controlling the electrographic onset of a seizure of claim 1 further comprising a high level controller that communicates with the intelligent data processing unit to retune at least one parameter that is used to extract and select a feature.

5. The system for predicting and controlling the electrographic onset of a seizure of claim 1 further comprising an external portable module including an external communications unit that enables the transfer of physiological data that is sensed in the individual to the external portable module for analysis and storage.

6. The system for predicting and controlling the electrographic onset of a seizure of claim 5 wherein the external portable module further comprises a display device that shows the probability output from the intelligent data processing unit for having a seizure in at least one time frame.

7. The system for predicting and controlling the electrographic onset of a seizure of claim 5 wherein the external portable module further comprises an alarm device which is activated to alert the individual of an oncoming seizure when the probability of having a seizure in at least one time frame exceeds an adaptive threshold.

8. The system for predicting and controlling the electro graphic onset of a seizure of claim 5 wherein the external portable module further comprises a battery recharger.

9. The system for predicting and controlling the electrographic onset of a seizure of claim 5 wherein the external portable module further comprises at least one of a microprocessor, a digital signal processor, a field programmable gate array, and an application specific integrated circuit.

10. The system for predicting and controlling the electro graphic onset of a seizure of claim 5 wherein the external communications unit communicates with the intelligent data processing unit by any one of telemetry, magnetic induction, direct electrical connection, optical communication and ultrasonic communication.

11. The system for predicting and controlling the electrographic onset of a seizure of claim 5 wherein the external portable module further comprises a communications port that enables the external portable module to be connected to a serial or a parallel port of a computer system, and that enables the transmission of stored data from the external portable module through an Internet connection to another computer system where the transmitted data can be downloaded and stored.

12. The system for predicting and controlling the electro graphic onset of a seizure of claim 11 wherein the intelligent data processing unit is contained in an implantable device.

13. The system for predicting and controlling the electrographic onset of a seizure of claim 12 wherein the implantable device is implanted in the brain of the individual.

14. The system for predicting and controlling the electrographic onset of a seizure of claim 1 wherein the intelligent data processing unit is programmed into any one of a microprocessor, a digital signal processor, a field programmable gate array, and an application specific integrated circuit (ASIC) embedded on a microchip.

15. The system for predicting and controlling the electrographic onset of a seizure of claim 1 wherein the intelligent data processing unit comprises a preprocessor to amplify and filter the physiological signals.

16. The system for predicting and controlling the electrographic onset of a seizure of claim 1 wherein the intelligent data processing unit comprises a first feature extraction module to extract analog features from the preprocessed physiological signals.

17. The system for predicting and controlling the electrographic onset of a seizure of claim 16 wherein the intelligent data processing unit further comprises a second feature extraction module to extract digital features from the preprocessed physiological signals.

18. The system for predicting and controlling the electrographic onset of a seizure of claim 17 wherein the intelligent data processing unit further comprises a feature vector generator module that combines a plurality of extracted features based on a running window technique.

19. The system for predicting and controlling the electrographic onset of a seizure of claim 18 wherein the intelligent data processing unit further comprises an intelligent prediction analysis and classification module operating on a central processor that analyzes the feature vector to provide an estimation of the probability of having a seizure for one or more time frames.

20. The system for predicting and controlling the electrographic onset of a seizure of claim 19 further comprising an internal communications unit to enable the transfer of physiological data that is sensed in the individual by a central processor in the intelligent data processing unit to an external portable module that displays the probability of seizure for at least one time frame.

21. The system for predicting and controlling the electrographic onset of a seizure of claim 1 wherein the intelligent data processing unit comprises an on-board memory to record the physiological signals over a period of time based on a capacity of the memory.

22. The system for predicting and controlling the electrographic onset of a seizure of claim 1 further comprising a neural network to perform the analysis of the feature vector.

23. The system for predicting and controlling the electrographic onset of a seizure of claim 22 wherein the neural network is at least one of a probabilistic neural network, a k-nearest neighbor neural network, and a wavelet neural network.

24. The system for predicting and controlling the electrographic onset of a seizure of claim 1 further comprising an internal electrical stimulation unit activated by the low level controller to electrically stimulate focal points to prevent synchronized nerve impulses as the therapeutic intervention measure.

25. The system for predicting and controlling the electrographic onset of a seizure of claim 1 further comprising a drug delivery system activated by the low level controller to provide chemical stimulation as by releasing small quantities of a drug as the therapeutic intervention measure.

26. The system for predicting and controlling the electro graphic onset of a seizure of claim 1 further comprising a special helmet activated by the low level controller to provide magnetic stimulation as the therapeutic intervention measure.

27. The system for predicting and controlling the electrographic onset of a seizure of claim 1 wherein the low level controller activates a stimulation unit to instruct the individual to initiate a sensory/perceptive stimulus as the therapeutic intervention measure.

28. The system for predicting and controlling the electro graphic onset of a seizure of claim 27 wherein the sensory/perceptive stimulus is any of a visual, an auditory, a tactile, a smell and a taste stimulus.

29. The system for predicting and controlling the electrographic onset of a seizure of claim 1 wherein the low level controller activates a stimulation unit to instruct the individual to initiate a cognitive stimulus as the therapeutic intervention measure.

30. The system for predicting and controlling the electro graphic onset of a seizure of claim 29 wherein the cognitive stimulus is any of a reading, a mathematical computation, and a logic reasoning problem stimulus.

31. The system for predicting and controlling the electrographic onset of a seizure of claim 1 wherein the preventive therapeutic intervention measure is adaptively controlled in response to a changing probability of seizure.