SYSTEM TO DELIVER ADAPTIVE EPIDURAL AND/OR SUBDURAL ELECTRICAL SPINAL CORD STIMULATION TO FACILITATE AND RESTORE LOCOMOTION AFTER A NEUROMOTOR IMPAIRMENT

• US 20160279418A1
• Filed: 10/29/2014
• Published: 09/29/2016
• Est. Priority Date: 10/31/2013
• Status: Active Application

• Current Assignee: Ecole polytechnique fãdãrale de lausanne epfl (Schweizerische Eidgenossenschaft)
• Original Assignee: Ecole polytechnique fãdãrale de lausanne epfl (Schweizerische Eidgenossenschaft)
• Inventors: Wenger, Nikolaus, Martin Moraud, Eduardo, Micera, Silvestro, Bonizzato, Marco, Courtine, Gregoire
• Granted Patent: US 10,265,525 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/1121 Determining geometric values, e.g. centre of rotation or angular range of movement
• CPC Class Codes: A61B 5/1127 using markers
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

The present invention provides a closed-loop system for real-time control of epidural and/or subdural electrical stimulation comprising: means for applying to a subject neuromodulation with adjustable stimulation parameters, said means being operatively connected with a real-time monitoring component comprising sensors continuously acquiring feedback signals from said subject, said signals being neural signals and/or signals providing features of motion of said subject, said system being operatively connected with a signal processing device receiving said feedback signals and operating real-time automatic control algorithms, said signal processing device being operatively connected with said means and providing said means with new stimulation parameters, with minimum delay. The system of the invention improves consistency of walking in a subject with a neuromotor impairment. A Real Time Automatic Control Algorithm is used, comprising a feedforward component employing a single input-single output model (SISO), or a multiple input-single output (MISO) model.

Claims

1. A closed-loop system for real-time control of epidural and/or subdural electrical spinal cord stimulation comprising

means for applying to a subject neuromodulation with adjustable stimulation parameters, said means a) being operatively connected with

a real-time monitoring component comprising sensors continuously acquiring feedback signals from said subject, said signals being neural signals and/or signals providing features of motion of said subject, said system b) being operatively connected with

a signal processing device receiving said feedback signals and operating real-time automatic control algorithms, said signal processing device being operatively connected with said means a) and providing said means a) with new stimulation parameters, with minimum delay.

2. The system of claim 1, wherein said means a) comprise an epidural and/or subdural electrical stimulation device.

3. The system of claim 1, wherein said stimulation parameters are selected from the group consisting of waveform, amplitude, pulse width and frequency.

4. The system of claim 2, wherein, said means a) comprise one or more electrodes, preferably an electrode array.

5. The system of claim 4, wherein said means a) also comprise an implantable pulse generator.

6. The system of claim 1, wherein said means a) provide a stimulation frequency comprised between 5 and 120 Hz, and with a resolution of 1 Hz

7. The system of claim 1, wherein said means a) provide phasic stimulation or burst stimulation.

8. The system of claim 1, wherein said means a) are applied to at least two stimulation sites and each stimulation site can be independently turned on or off.

9. The system of claim 4, wherein electrical stimulation is location-specific and wherein stimulation parameters of each individual electrode can be independently modified in real-time.

10. The system of claim 1, wherein said signal processing device c) automatically detects gait events and defines specific sub-phases of gait during locomotion, preferably the stance-phase and the swing-phase.

11. The system of claim 1, wherein said means a) comprise electrodes applied on sacral and lumbar sites which are alternatively activated to promote, respectively, whole-limb extension or flexion.

12. The system of claim 1, wherein said monitoring component b) comprises limb position markers or sensors.

13. The system of claim 1, wherein said feedback signals acquired by said real-time monitoring component b) are neural signals, in particular cortical signals, recorded from sensory, motor, sensorimotor or pre-motor cortex.

14. The system of claim 1, wherein said feedback signals acquired by said real-time monitoring component b) are both neural signals and signals providing features of motion of said subject.

15. The system of claim 1, wherein said signal processing device c) operates a program comprising an automatic control algorithm that interfaces simultaneously with data flow from said real-time monitoring component b) and the means for neuromodulation a) in real-time.

16-19. -19. (canceled)

20. A method for determining optimal stimulation parameters for a subject suffering from a neuromotor impairment and undergoing a process for facilitating locomotor functions comprising the following steps:

determining a first electrical stimulation which has been applied to said subject bearing means for applying an epidural and/or subdural electrical stimulation with adjustable stimulation parameters;

acquiring feedback signals from said subject, said signals being neural signals and/or signals providing features of motion of said subject, through a real-time monitoring system, while this first stimulation occurs;

transmitting said feedback signals to a signal processing device;

calculating by means of said signal processing device operating a Real Time Automatic Control Algorithm new stimulation parameters;

providing instructions to said means of step a) for applying a second epidural and/or subdural electrical stimulation so that said means are capable to administer a second electrical stimulation with said new stimulation parameters calculated in step d) to said subject.

21. The method of claim 20, wherein the Real Time Automatic Control Algorithm comprises a feedforward component employing an input-output model which is a single input-single output model (SISO), wherein one stimulation parameter is changed to control one gait feature, or, alternatively a multiple input-single output (MISO) model, wherein multiple stimulation parameters are adjusted to obtain a single desired gait feature (output).