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Publication Number

US-11285321-B2

Patent

Publication Date

2022-03-29

Expiration Date

2037-11-14


Abstract

Methods and apparatuses for sensory electrical stimulation of the peripheral nervous system to improve human motor function and performance are described. Methods and devices may be used to enhance physical performance of athletes, professionals, and gamers or improve motor function (hand, finger and limb movement) in patients rehabilitating from neurological deficits and impairments caused by stroke, traumatic brain injury and other neurologic or non-neurologic conditions. These apparatuses and methods may be used for physical training and mental training (to improve memory and functional performance including motor coordination, limb-eye coordination, occupational and recreational skills) through periodic or sustained sensory electrical stimulation. Treatment plans may be based on biomarkers and may be used alone or in combination with other apparatuses. Learning and feedback techniques individualize treatment parameters depending on the subject's neurologic and motor function in diseased patients and healthy users.

Core Innovation

Methods and apparatuses for sensory electrical stimulation of the peripheral nervous system to improve human motor function and performance are described. These methods and devices are configured to apply sub-sensory or nearly sub-sensory electrical stimulation to peripheral nerves, including the radial, ulnar, and median nerves, to enhance motor function such as hand, finger, and limb movement. The methods incorporate closed-loop control where stimulation parameters are iteratively adjusted based on biomarkers, such as electroencephalogram (EEG) data, and performance indicators obtained from tasks activating the stimulated nerves, including gaming or manual dexterity tasks.

The apparatuses described include stimulators with electrodes, biomarker monitors, and controllers that modulate stimulation in real time according to measured biological and performance signals. These devices may be wearable in various forms, such as wrist bands, gloves, sleeves, or patches, and include features like haptic feedback, motion sensors, and training systems integrated with games or assessment tasks. Training and feedback techniques individualize treatment parameters to the neurologic and motor function of diseased patients and healthy users, enabling both therapeutic rehabilitation and non-therapeutic performance enhancement.

The invention addresses the variability and limitations of prior somatosensory electrical stimulation approaches by providing a closed-loop system that modulates cortical control through peripheral nerve stimulation. This system uses biomarkers such as EEG low-frequency oscillations to titrate stimulation parameters, optimize dosing, and improve reproducibility and efficacy. The closed-loop methods and devices are applicable to a wide range of conditions, including stroke rehabilitation, neurological deficits, and motor performance enhancement in healthy individuals.

Claims Coverage

The patent includes two main independent claims relating to methods of improving peripheral nerve function through closed-loop control of electrical stimulation based on biomarker and performance feedback.

Closed-loop transdermal electrical stimulation for stroke rehabilitation

A method comprising applying transdermal electrical stimulation to one or more of the radial, ulnar, and median nerves of a subject recovering from stroke; measuring EEG from the subject; determining an indicator of low-frequency cortical oscillations from the delta or theta wave portion of the EEG; adjusting the stimulation based on this indicator; and repeating these steps.

Closed-loop modulation of peripheral nerve stimulation based on performance in manual tasks

A method comprising applying transdermal electrical stimulation to one or more of the radial, ulnar, and median nerves; performing a manual training task involving finger individuation; estimating a performance metric based on finger individuation correlated with low-frequency cortical oscillations; measuring EEG including delta or theta wave changes; adjusting the electrical stimulation based on the EEG and performance metric; and repeating these steps over multiple days.

These inventive features provide closed-loop control of peripheral nerve electrical stimulation by integrating biomarker measurement, including EEG low-frequency oscillations, and performance metrics from training tasks to personalize and optimize stimulation parameters for improved motor function, especially in stroke rehabilitation and manual dexterity enhancement.

Stated Advantages

Improved clinical efficacy of peripheral nerve stimulation by individualized closed-loop control based on biomarkers and performance feedback.

Ability to enhance motor function and dexterity in patients recovering from neurological deficits such as stroke.

Applicability to both therapeutic rehabilitation and non-therapeutic performance enhancement in healthy individuals, including athletes and gamers.

Integration with training tasks and adaptive algorithms provides personalized treatment plans and feedback.

Wearable and comfortable devices enable continuous or periodic use with minimal irritation due to sub-sensory stimulation levels.

Documented Applications

Improvement of motor function and rehabilitation of hand, finger, and limb movements in patients recovering from stroke, traumatic brain injury, and other neurological or non-neurological conditions.

Enhancement of physical performance and motor coordination in athletes, professionals, dancers, musicians, physicians, gamers, and typists.

Treatment of neurological movement disorders, gait disturbances, Parkinson's disease, essential tremor, muscle cramps, restless leg syndrome, post-polio syndrome, and peripheral neuropathies.

Management of pain, migraines, tic disorders, trigeminal neuralgia, reflex sympathetic dystrophy, dysphagia, spastic bladder, urinary incontinence, erectile dysfunction, premature ejaculation, sleep disorders including insomnia, and obstructive sleep apnea.

Physical and mental training to improve memory, functional performance, limb-eye coordination, occupational and recreational skills through periodic or sustained sensory electrical stimulation combined with adaptive training games.

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