# US 9,433,797 B2 · Apparatus and method for electromagnetic treatment of neurodegenerative conditions

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- Number: US 9,433,797 B2
- Document ID: US9433797B2
- Status: Granted
- Kind: B2
- Application number: 14/171,613
- Filed: 2014-02-03
- Published: 2014-08-07
- Granted: 2016-09-06
- Earliest claimed: 2003-12-05
- Assignees: Rio Grande Neurosciences, Inc.
- Applicants: Rio Grande Neurosciences, Inc.
- Inventors: Arthur A. Pilla; Andre' A. DiMino; Iyer Viswanathan; Diana Casper; Berish Strauch
- Web page: https://patentgrep.com/patent/US9433797B2

## CPC

- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61N 2/008: {for pain treatment or analgesia}
- A61N 2/02: using magnetic fields produced by coils, including single turn loops or electromagnets (A61N2/12 takes precedence)
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Described herein are methods of treating neurological injury and conditions, in particular neurodegenerative conditions. These treatment methods can include the steps of generating a pulsed electromagnetic field from a pulsed electromagnetic field source and applying the pulsed electromagnetic field in proximity to a target region.

## Claims

### Claim 1

A method for treating a neurodegenerative disease or condition in a patient in need thereof, the method comprising:
placing a pulsed electromagnetic device comprising a pulsed electromagnetic field source external to a patient's head and in proximity to a target region for treatment through a skull;
generating a pulsed electromagnetic field from the pulsed electromagnetic field source;
applying the pulsed electromagnetic field through the skull to a target cerebrofacial tissue; and
reducing a physiological response to the neurodegenerative disease or condition by applying the pulsed electromagnetic field;
wherein the pulsed electromagnetic field has a strength of 200 milliGauss or less.

### Claim 2 (depends on 1)

The method of claim 1, wherein the target cerebrofacial tissue is a head.

### Claim 3 (depends on 1)

The method of claim 1, wherein the target cerebrofacial tissue is a brain.

### Claim 4 (depends on 1)

The method of claim 1, wherein applying the pulsed electromagnetic field treats a degenerative neurological pathology.

### Claim 5 (depends on 1)

The method of claim 1, wherein pulsed electromagnetic field is applied for 1 minute to 240 minutes.

### Claim 6 (depends on 1)

The method of claim 1, wherein further comprising placing the pulsed electromagnetic field source in proximity to the cerebrofacial tissue.

### Claim 7 (depends on 1)

The method of claim 1, wherein generating the pulsed electromagnetic field comprises generating an electromagnetic field with a pulse burst envelope of mono- or bi-polar rectangular or sinusoidal pulses which induce peak electric fields between 10-8 and 10 volts per centimeter (V/cm).

### Claim 8 (depends on 1)

The method of claim 1, wherein generating the pulsed electromagnetic field comprises generating at least one burst of sinusoidal, rectangular, chaotic, or random wave shapes, having a frequency content in a range of about 0.01 Hz to about 100 MHz, having a burst duration from about 0.1 to about 100 msec, and having a burst repetition rate from about 0.01 to about 1000 bursts/second.

### Claim 9 (depends on 1)

The method of claim 1, wherein the pulsed electromagnetic field comprises about 0.01 millisecond to about 10 millisecond burst of 27.12 MHz sinusoidal waves repeating at about 1 to about 100 bursts per second.

### Claim 10 (depends on 9)

The method of claim 9, wherein the pulsed electromagnetic field has an induced electric field from about 0.001 mV/cm to about 100 mV/cm.

### Claim 11 (depends on 1)

The method of claim 1, wherein the neurodegenerative disease or condition includes Parkinson's disease.

### Claim 12 (depends on 1)

The method of claim 1, wherein applying the pulsed electromagnetic field prevents the deterioration of neurons in the cerebrofacial tissue.

### Claim 13 (depends on 1)

The method of claim 1, wherein applying the pulsed electromagnetic field increases a neuron population in the cerebrofacial tissue.

### Claim 14 (depends on 1)

The method of claim 1, wherein applying the pulsed electromagnetic field increases cytokines in the cerebrofacial tissue.

### Claim 15 (depends on 1)

The method of claim 1, wherein applying the pulsed electromagnetic field increases growth factors in the cerebrofacial tissue.

### Claim 16 (depends on 1)

The method of claim 1, wherein applying the pulsed electromagnetic field enhances blood flow in the cerebrofacial tissue.

### Claim 17

A method for treating a neurodegenerative disease or condition a in a patient in need thereof, the method comprising:
placing a pulsed electromagnetic device comprising a pulsed electromagnetic field source external to a patient's head and in proximity to a target region for treatment through a skull;
generating a pulsed electromagnetic field from the pulsed electromagnetic field source; applying the pulsed electromagnetic field through the skull to a target region affected by the neurodegenerative disease or condition; and
reducing a physiological response to the neurodegenerative disease or condition by applying the pulsed electromagnetic field,
wherein the pulsed electromagnetic field has a strength of 200 milliGauss or less.

### Claim 18 (depends on 17)

The method of claim 17, wherein the physiological response is inflammation.

### Claim 19 (depends on 17)

The method of claim 17, wherein the physiological response is increased intracranial pressure.

### Claim 20 (depends on 17)

The method of claim 17, further comprising
monitoring the physiological response; and
continuing to apply the pulsed electromagnetic field until an acceptable level of the physiological response is reached.

### Claim 21 (depends on 20)

The method of claim 20, wherein the physiological response is increased intracranial pressure and the acceptable level is below about 20 mmHg.

### Claim 22 (depends on 17)

The method of claim 17, wherein generating the pulsed electromagnetic field comprises a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

### Claim 23 (depends on 17)

The method of claim 17, wherein the pulsed electromagnetic field comprises a 3 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

### Claim 24 (depends on 17)

The method of claim 17, wherein the pulsed electromagnetic field comprises a 4 msec burst of 27.12 MHz sinusoidal waves repeating at 2 Hz.

### Claim 25 (depends on 17)

The method of claim 17, wherein the neurodegenerative injury or condition is Parkinson's disease or Alzheimer's disease.

### Claim 26 (depends on 17)

The method of claim 17, wherein the pulsed electromagnetic field comprises about a 1 msec to about a 10 msec burst of 27.12 MHz sinusoidal waves repeating at about 1 Hz to about 10 Hz.

### Claim 27 (depends on 17)

The method of claim 17, wherein the pulsed electromagnetic field comprises an ISM carrier frequency modulated at about a 1 msec to about a 10 msec burst repeating at about 1 Hz to about 10 Hz.

### Claim 28 (depends on 17)

The method of claim 17, wherein the pulsed electromagnetic field comprises an ISM carrier or any other radio frequency up to 10,000 GHz, configured to modulate a rhythm of a physiological system.

### Claim 29 (depends on 28)

The method of claim 28, wherein the physiological system is the central nervous system.

### Claim 30 (depends on 17)

The method of claim 17, wherein the pulsed electromagnetic field comprises an ISM carrier or any other radio frequency up to 10,000 GHz, configured to modulate a rhythm of a brain.

### Claim 31 (depends on 17)

The method of claim 17, wherein the electromagnetic field comprises a waveform that modulates at least one biological signaling pathway.

### Claim 32 (depends on 17)

The method of claim 17, wherein the pulsed electromagnetic field comprises an ISM carrier or any other radio frequency up to 10,000 GHz, configured to modulate a sleep pattern.

### Claim 33 (depends on 17)

The method of claim 17, wherein the pulsed electromagnetic field comprises an ISM carrier or any other radio frequency up to 10,000 GHz, configured to modulate slow-wave sleep in a sleep cycle to effect the production of human growth hormone.

### Claim 34 (depends on 17)

The method of claim 17, wherein the target region is a brain of the patient.

### Claim 35

A method for treating a neurodegenerative injury or condition in a patient in need thereof, the method comprising:
placing a pulsed electromagnetic device comprising a pulsed electromagnetic field source external to a patient's head and in proximity to a target region for treatment through a skull;
generating a first pulsed electromagnetic field from the pulsed electromagnetic field source;
applying the first pulsed electromagnetic field externally through a skull to a target region affected by the neurodegenerative injury or condition for a first treatment interval;
reducing a physiological response to the neurodegenerative injury or condition by applying the first pulsed electromagnetic field;
discontinuing the application of the first pulsed electromagnetic field for an inter-treatment period greater than zero; and
applying a second pulsed electromagnetic field in proximity to the target region;
wherein the first and second pulsed electromagnetic fields each have strengths of 200 milliGauss or less.

### Claim 36 (depends on 35)

The method of claim 35, wherein the first and second pulsed electromagnetic fields are substantially the same.

### Claim 37 (depends on 35)

The method of claim 35, further comprising
monitoring the physiological response; and
modifying the first pulsed electromagnetic field to the second pulsed electromagnetic field in response to the monitoring step.

### Claim 38 (depends on 35)

The method of claim 35, further comprising
monitoring the physiological response; and
discontinuing treatment once an acceptable level of the physiological response is reached.

### Claim 39 (depends on 35)

The method of claim 35, further comprising attenuating inflammatory cytokines and growth factors at the target region by applying the first pulsed electromagnetic field or the second pulsed electromagnetic field to the target region.

### Claim 40 (depends on 35)

The method of claim 35, further comprising accelerating the healing of the target region by applying the first pulsed electromagnetic field or the second pulsed electromagnetic field to the target region.

### Claim 41 (depends on 35)

The method of claim 35, wherein applying the first pulsed electromagnetic field in proximity to a target region affected by the neurodegenerative injury or condition to reduce a physiological response comprises reducing a concentration of IL-1β.

### Claim 42 (depends on 35)

The method of claim 35, wherein the neurodegenerative injury or condition is Parkinson's disease or Alzheimer's disease.

### Claim 43 (depends on 35)

The method of claim 35, further comprising increasing a growth factor in the target region.

### Claim 44 (depends on 43)

The method of claim 43, wherein increasing a growth factor in the target region enhances angiogenesis.

### Claim 45 (depends on 43)

The method of claim 43, wherein increasing a growth factor in the target region enhances nervous tissue regeneration.

### Claim 46 (depends on 43)

The method of claim 43, wherein the growth factor is selected from the group consisting of FGF-2, VEGF, and BMP.

### Claim 47 (depends on 35)

The method of claim 35, wherein the target region is a brain of the patient.

### Claim 48

A method for treating a neurodegenerative injury or condition in a patient in need thereof, the method comprising:
placing a pulsed electromagnetic device comprising a pulsed electromagnetic field source external to a patient's head and in proximity to a target region for treatment through a skull;
generating a pulsed electromagnetic field from the pulsed electromagnetic field source;
externally applying the pulsed electromagnetic field through a skull to a target brain region affected by the neurodegenerative injury or condition;
modulating microglia activation in the target brain region by externally applying the pulsed electromagnetic field; and
reducing a physiological response to the neurodegenerative injury or condition by modulating microglia activation in the target brain region,
wherein the pulsed electromagnetic field has a strength of 200 milliGauss or less.

### Claim 49 (depends on 48)

The method of claim 48, wherein modulating microglia activation comprises reducing microglia activation in the target brain region.

### Claim 50 (depends on 48)

The method of claim 48, wherein the neurodegenerative injury or condition is Parkinson's disease or Alzheimer's disease.

### Claim 51

A method of promoting neurodegenerative repair or growth following a neurodegenerative injury or condition comprising:
placing a treatment coil of a self-contained, lightweight, and portable treatment apparatus externally to a target treatment site in need of repair or development, wherein the treatment apparatus comprises a conformable coil having one or more turns of wire and a control circuit;
generating an electromagnetic field using the treatment coil;
delivering the electromagnetic field through the skull to the target treatment site using the treatment coil; and
reducing a physiological response to the neurodegenerative injury or condition by delivering the electromagnetic field;
wherein the pulsed electromagnetic field has a strength of 200 milliGauss or less.

### Claim 52 (depends on 51)

The method of claim 51, wherein generating an electromagnetic field comprises generating at least one burst of sinusoidal, rectangular, chaotic, or random waveforms, having a frequency content in a range of about 0.01 Hz to about 10,000 MHz, having a burst duration from about 0.1 to about 100 msec, at a peak amplitude of 0.001 G to about 0.1 G, and having a burst repetition rate from about 0.01 to about 100 bursts/second.

### Claim 53 (depends on 51)

The method of claim 51, further comprising delivering the electromagnetic field for a period of about 1 minute to about 240 minutes.

### Claim 54 (depends on 51)

The method of claim 51, wherein the physiological response is a cognitive deficiency.

### Claim 55 (depends on 51)

The method of claim 51, wherein the neurodegenerative injury or condition is Parkinson's disease or Alzheimer's disease.

### Claim 56 (depends on 51)

The method of claim 51, wherein the target treatment site is a brain.
