WO2023134322A1 - 用于传递可变脉冲的装置 - Google Patents
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Definitions
- the present invention relates to a device that uses repetitive transcranial magnetic stimulation (rTMS) to regulate brain activity in mammals.
- the rTMS with variable pulse intervals is given to a time sufficient to regulate brain activity to achieve improvement. Purpose of physiological condition or clinical condition.
- the pulse interval of rTMS ranged from 66.00 milliseconds (ms) to 200.00 milliseconds.
- the present invention relates to electrical stimulation of the brain by administering variable electrical pulse intervals at times sufficient to modulate brain activity to achieve improvements in physiological or clinical conditions. Variable EMP intervals are delivered in a random fashion.
- the setting of the pulse interval time in the aforementioned magnetic stimulation and electrical stimulation does not depend on or be derived from electroencephalography (Electroencephalography, EEG), other mammalian biometric data (biometric data).
- EEG Electroencephalography
- biometric data biometric data
- the present invention also includes electromagnetic stimulation devices for providing variable pulse intervals of electrical or magnetic stimulation, preferably the variable pulses are not based on the patient's EEG data, but are derived from EEG data or other biometric measurements.
- Repetitive transcranial magnetic stimulation has been used to treat many psychological and medical conditions, such as major depressive disorder, Parkinson's disease, post-traumatic stress disorder, Alzheimer's disease, autism spectrum disorder (ASD), thinking Sensory disorders, pain management, etc.
- US Patent Publication No. 2009/0082690 disclosed a treatment protocol using rTMS in which the magnetic field output of rTMS is adjusted according to the patient's EEG natural frequency in an attempt to change the patient's natural EEG frequency.
- US Pat. No. 9,308,385 uses a different approach to manage rTMS, which is based on the frequency of a biological metric, or harmonics of a characteristic metric.
- rTMS therapy has consisted of delivering a single frequency at a preset intensity as electromagnetic stimulation.
- the present invention provides a novel rTMS delivery system that delivers rTMS or electrical stimulation with variable pulse intervals, the probability of the pulse intervals being dependent on a given type of noise function, Examples include Gaussian, pink noise, or white noise.
- the power/intensity of electromagnetic stimulation can also be varied.
- electrical and magnetic stimulation devices are programmed to deliver variable pulse intervals of magnetic or electrical stimulation.
- the present invention offers significant advantages over prior art techniques that use single frequency magnetic or electrical stimulation delivery. Existing technologies provide a fixed frequency of stimulation, or require (a) the patient's EEG or ECG; and (b) analysis of the biometric data for a clearer detection pattern, followed by subjective interpretation of the data.
- the device for regulating the brain activity of mammals is realized by administering repetitive transcranial magnetic stimulation (rTMS) with pulse intervals varying between 66.00 milliseconds (ms) and 200.00 milliseconds to mammals.
- rTMS repetitive transcranial magnetic stimulation
- the device could also be used to administer variable electrical stimulation to the brain.
- the device is effective for treating brain dysfunction diseases or physical conditions.
- the variable pulse intervals used for magnetic and electrical stimulation are generated by a preprogrammed noise generator, such as Gaussian, pink noise, or white noise, and truncated to match the rhythm of brain activity.
- This setup does not use EEG data, is derived from EEG data, or other biometrics (eg, heart rate, respiration rate, or the like).
- the physiological and medical conditions that can be improved by modulating brain activity according to the present invention can be any condition in which abnormal brain activity creates a specific condition.
- the diseases to be treated include but are not limited to autism spectrum disorder (ASD), Alzheimer's disease (Alzheimer's Disease, AD), post-traumatic stress disorder (Post Traumatic Stress Disorder, PTSD), traumatic brain injury (traumatic brain injury, TBI), memory impairment, depression, pain, addiction, substance use disorder (substance use disorder, SUD), obsessive-compulsive neurosis (Obsessive Compulsive disorders, OCD), anxiety disorder, Parkinson's disease, High blood pressure, libido dysfunction, abnormal motor function, short stature in children, stress, obesity, sleep disorders, eating disorders, inattention, language disorders, mental retardation, cognitive impairment, attention deficit hyperactivity disorder (Attention Deficit Hyperactivity Disorders, ADHD), schizophrenia, lethargy, bipolar disorders, tinnitus, fibromyalgia, chronic Lyme disease, rheuma
- rTMS repetitive transcranial magnetic stimulation
- the aforementioned improvement refers to the improvement observed both from the clinical assessment of the patient and the patient's healthcare professional.
- the power or intensity of the magnetic stimulation is typically below the patient's motor threshold, preferably 50% to 90% of the patient's motor threshold, but may be higher or lower in intensity.
- the TMS involved in the present invention is also suitable for electrical stimulation of the brain, for example, through deep brain stimulation (deep brain stimulation), or transcutaneous electrical stimulation (such as Alpha-Stim cranial electrotherapy stimulation (CES)) device .
- the brain activity of mammals is adjusted by administering electrical stimulation with variable electrical pulse intervals to mammals, the duration of which is sufficient to regulate brain activity, resulting in an improvement in its physiological or clinical condition.
- electrical stimulation is performed in a random fashion.
- the pulse intervals of the random variable are spaced time periods according to a Gaussian distribution having a determined peak and established cut-off point. This embodiment applies to the treatment of multiple frequencies/multiple regions of specific brain waves associated with specific brain dysfunction diseases or physical conditions described herein.
- Figure 1 is an example of a patient being treated with an rTMS device.
- Figure 2 is an example of a patient being treated with an electrical stimulation device.
- TTL Transistor-transtor-logic
- Figure 4 is a Gaussian distribution probability map.
- the term "mammal” includes any mammal, especially a human, and non-human mammals include non-human primates, zoo animals, companion animals (dogs, cats) and performance animals (eg, racehorses and breeding animals). Any reference to “human” herein applies to other mammals exhibiting the same physiological or medical condition. Any reference to a “patient” herein is applicable to any mammal, preferably a human being, who may experience the particular condition of the referenced patient.
- the terms "variable pulsed interval, random pulsed interval, variable pulsed interval, random variable pulsed interval” mean that magnetic stimulation is delivered at different time intervals over time.
- variable time intervals are generated completely randomly by a software program, and the probability of each pulse included in the treatment protocol is weighted by a Gaussian distribution with a given mean and standard deviation.
- Random pulse intervals can also be based on white noise functions or/and pink noise functions.
- pre-programmed white noise generators and pink noise generators can be used to determine random pulse intervals.
- a patient whose brain activity is at least in part responsible for a physical or medical condition has been diagnosed by administering TMS pulses varying between 66.00 milliseconds (ms) and 200.00 ms for treatment.
- the computer program is used to generate TTL pulses or other triggers, and then through the TMS device to generate variable pulse intervals, preferably random pulse intervals.
- the transcranial magnetic stimulation is delivered in the form of repetitive transcranial magnetic stimulation (rTMS).
- rTMS is administered to patients at variable pulse intervals, long enough to modulate brain activity to improve physiological or clinical conditions at the time of treatment.
- randomly variable pulse intervals are applied to rTMS manipulations of sufficient duration to modulate brain activity to improve physiological or clinical conditions.
- the treatment is given daily for one week, after which time the patient's progress will be reassessed.
- the exact timing of the repetitive pulses is not critical.
- the variability in pulse intervals can be predetermined by the healthcare professional choosing a particular pulse interval that defines a therapy. However, it is best to program the rTMS device to provide a random pulse interval of 66.00ms to 200.00ms. Training in six-second pulses per minute for 30 minutes is a good way to generate a 30-minute treatment session.
- the maximum intensity of the magnetic pulses is usually set at or below the patient's motor threshold, but can be managed at the patient's motor threshold.
- the peak pulse power/intensity of rTMS is preferably set at approximately 50-90% of the patient's motor threshold. Typically, the power/intensity may be 0.1-99% of motor threshold, 10-90% of motor threshold, or 40-85% of motor threshold.
- variable pulse intervals are spaced apart continuous time intervals according to a Gaussian distribution with a defined peak value and predetermined cutoffs at both ends of the continuous time intervals. point.
- This embodiment can be used to treat specific brain wave frequencies/regions associated with specific brain dysfunction diseases or medical conditions.
- the value of the peak of the Gaussian distribution and the cutoff points on either side of the peak are not critical to the practice of the invention and will be based on various factors considered by the patient's healthcare professional. For example, when treating diseases or diseases related to ⁇ -brain wave dysfunction, the peak value of the pulse interval is 100.00ms, the cut-off point is 125.00ms and 83.00ms, and the pulse intervals of each sequence are randomly generated within this time interval.
- FIG. 4 an example of the time interval map presented in it presents a Gaussian distribution, and the X-axis of the map shows the time interval (in milliseconds), and the Y-axis shows the relationship of probability.
- the center line C2 represents the peak of the Gaussian distribution. Cutoffs C1 and C3 represent cutoffs on either side of C2.
- the application revealed by the Gaussian distribution shown in Fig. 4 is that when C1 is 125.00ms, C2 is 100.00ms, and C3 is 83.00ms, that is, the time interval range of the random pulse interval is between 83.00ms and 125.00ms.
- the distance between C1 and C2 on the X-axis is the same as the distance between C2 and C3 on the X-axis
- the axes are equidistant.
- the Gaussian-distributed value of the random pulse interval refers to the number of times it occurs per second.
- the rTMS treatment of the present invention is carried out by using the existing treatment plan through the magnetic coil.
- the timing of actual magnetic stimulation within the set time interval will vary according to each clinical presentation.
- the magnetic stimulation administered is optimally performed in rTMS sessions (rTMS session) for 6 consecutive seconds per minute. Sessions can last from 15 to 60 minutes, with 30 minutes being optimal.
- the magnetic coil may be placed near or against the patient's head, preferably near the frontal lobe.
- Graph in Table 1 listing the random magnetic pulse intervals during the 30 min treatment period.
- the left hand column (downwards) corresponds to the training number, i.e. there is a 6 second treatment every minute.
- the horizontal row corresponds to the start time in milliseconds (ms) of 127 ms between pulses from each particular training session (ie T1, T2, T3...etc).
- T1 is triggered 127ms after the initial pulse
- T2 is triggered 95ms after T1
- T3 is triggered 70ms after T2, and so on for the horizontal row of training #1.
- Training #1 lasted 6 seconds.
- each 6-minute training burst is newly randomly generated.
- training #2 starts the same way.
- T11 to T43 are omitted, but they are random pulses.
- Figure 3 shows the variability of TLL pulses during a 6 second treatment period in accordance with the present invention, in contrast to a scheme employing a single frequency where all pulses would be equidistant from each other within a 6 second treatment period.
- FIG. 1 shows a magnetic stimulation device of the present invention, including a coil 201 , a power supply 202 and a computer 203 for controlling stimulation parameters of variable pulses.
- the power supply 202 and the computer 203 can be manufactured as a single unit control module (not shown). In general, the control module controls the TTL pulses and the delivery of magnetic stimulation by the coil 201 .
- the control module controls the TTL pulses and the delivery of magnetic stimulation by the coil 201 .
- the power supply 202 is turned on, current passes through the coil to generate a magnetic field, and the computer 203 is programmed to drive the coil 201 to generate the variable pulses described in the present invention.
- the encapsulated magnetic coil assembly is positioned on or adjacent to the head for therapy.
- An electrical stimulation device comprising two or more electrode pads (electrode pads) to be attached to the scalp, a power source configured to generate current to the electrodes of the aforementioned electrode pads, and a computer program to guide the aforementioned electrode pads. Electrical stimulation with variable pulses.
- the power source of the electro-stimulation device is a battery, making it convenient to use in the medical treatment of over-the-counter home transcutaneous electrical nerve stimulation (TENS unit) devices.
- TESS unit transcutaneous electrical nerve stimulation
- deep brain stimulation deep brain stimulation
- electrodes are implanted in dysfunctional areas of the brain.
- the electrodes deliver electrical impulses to targeted areas of the brain, and the electrodes are connected by wires to a pulse generator or neurostimulator.
- a pulse generator or neurostimulator supplies electrical current to the electrodes, delivering random electrical impulses to targeted brain regions.
- the pulse generator or neurostimulator is programmed to deliver random electrical pulses when needed.
- a pulse generator/neurostimulator is usually surgically implanted under the skin. The delivery of random electrical pulses is not based on or derived from the patient's EEG data.
- Fig. 2 shows the battery-powered electric stimulation device of the present invention, which includes an electric pulse generator 301 powered by a battery (not shown), and a pair of electrode patches 304, 305 connected to the electric pulse generator 301 through wires 302, 303. module.
- the control module is grounded through the ground wire.
- the digital or computer program of the control module directs the variable electrical stimulation according to the invention.
- Example 1 Treating PTSD (Post Traumatic Stress Disorder) and Substance Use Disorder (SUD)
- rTMS random variable repetitive transcranial magnetic stimulation
- On subsequent follow-up examinations of the patient nocturnal sleep, mood, tinnitus, muscle pain, cessation of alcohol consumption, cessation of marijuana use, and attention span, all improved after 4 days of daily treatment.
- a 56-year-old female patient was diagnosed with long-term COVID-19 and didn't smelled for more than a year. She was treated with repeated transcranial magnetic stimulation (rTMS) for two weeks with a random variable of the present invention. Prior to rTMS treatment, patients' motor thresholds were determined. Patients received 6 seconds of randomized magnetic stimulation every 60 seconds for 30 minutes at a power of 80% of the patient's motor threshold. After the first treatment, her sense of smell returned immediately. In subsequent follow-up examinations of the patient, she reported improvements in nighttime sleep, fatigue, muscle pain, and shortness of breath.
- rTMS repeated transcranial magnetic stimulation
- rTMS random variable repetitive transcranial magnetic stimulation
- rTMS repeated transcranial magnetic stimulation
- rTMS random variable repetitive transcranial magnetic stimulation
- the motor threshold of the racers was determined.
- the racers received 6 seconds of randomized magnetic stimulation every 60 seconds for 30 minutes at 70% of the patient's motor threshold.
- rTMS randomized variable repetitive transcranial magnetic stimulation
- Paralyzed males were treated with random variable repetitive transcranial magnetic stimulation (rTMS) of the present invention for 6 weeks (Monday to Friday).
- rTMS random variable repetitive transcranial magnetic stimulation
- motor thresholds were determined in paralyzed divers. Paralyzed divers received 6 seconds of randomized magnetic stimulation every 60 seconds for 30 minutes at a power of 70% of the patient's motor threshold. 2 weeks after the start of treatment, the diver was able to feel his legs and move his toes. At the end of five weeks, the divers were able to stand up.
- Example 8 Reduces seizures and improves cognition, coordination, and muscle control
- Example 9 Treatment of Alzheimer's patients with rTMS based on Gaussian distribution
- rTMS randomized variable repetitive transcranial magnetic stimulation
- Pulses were administered in a Gaussian distribution pattern with a peak at 100 ms and cutoffs at 83 ms and 125 ms.
- rTMS treatment determine the patient's motor threshold. Patients received 6 seconds of randomized magnetic stimulation every 60 seconds for 30 minutes at a power of 80% of the patient's motor threshold.
- the male reported problems with nocturnal sleep, memory, speaking and reading, and attention span, which improved after 2 days of daily treatment.
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Abstract
Description
Claims (14)
- 一种可编程rTMS装置,其特征在于,包括磁线圈,所述磁线圈用于传递具有多变的脉冲间隔的rTMS脉冲,所述多变的脉冲间隔是随机变量的脉冲间隔,所述多变的脉冲间隔是由高斯分布、白噪音函数或粉红噪音函数来决定。
- 根据权利要求1所述的可编程rTMS装置,其特征在于,还包括计算机程序,所述计算机程序用于引导所述磁线圈用来传递具有所述多变的脉冲间隔的rTMS脉冲。
- 根据权利要求1所述的可编程rTMS装置,其特征在于,所述多变的脉冲间隔由所述白噪音函数或/及所述粉红噪音函数来决定。
- 根据权利要求1所述的可编程rTMS装置,其特征在于,所述多变的脉冲间隔是间隔开来的连续时间区间,所述连续时间区间根据高斯分布而定,所述高斯分布具有决定峰值以及在所述连续时间区间的两端的既定截止点。
- 根据权利要求4所述的可编程rTMS装置,其特征在于,所述决定峰值为100.00ms的脉冲,第一个所述既定截止点为125.00ms的脉冲,第二个所述既定截止点为83.00ms的脉冲。
- 根据权利要求1所述的可编程rTMS装置,其特征在于,所述多变的脉冲间隔的时间介于66.00ms至200.00ms。。
- 一种rTMS装置和可编程***,其特征在于,包括磁线圈,所述磁线圈用于传递具有多变的脉冲间隔的rTMS脉冲,所述多变的脉冲间隔是随机变量的脉冲间隔,所述多变的脉冲间隔是由高斯分布、白噪音函数或粉红噪音函数来决定。
- 一种电刺激装置,其特征在于,包括:a.二个或更多个电极贴片;b.电源,用于产生电流至所述电极贴片;c.数字程序,用于引导具有可变脉冲的电刺激,其特征在于,所述可变脉冲是以多变的脉冲间隔来传递,所述多变的脉冲间隔是由高斯分布、白噪音函数或粉红噪音函数来决定。
- 根据权利要求8所述的电刺激装置,其特征在于,所述电源是电池。
- 根据权利要求8所述的电刺激装置,其特征在于,所述电刺激装置为经皮神经电刺激装置(TENS Unit)或深部脑刺激器(DBS)。
- 根据权利要求8至10中任一项所述的电刺激装置,其特征在于,所述多变的脉冲间隔是由所述白噪音函数或/及所述粉红噪音函数来决定。
- 根据权利要求8至10中任一项所述的电刺激装置,其特征在于,所述多变的脉冲间隔是间隔开来的连续时间区间,所述连续时间区间根据高斯分布而定,所述高斯分布具有决定峰值以及在所述连续时间区间的两端的既定截止点。
- 根据权利要求12所述的电刺激装置,其特征在于,所述决定峰值为100.00ms的脉冲,第一个所述既定截止点为125.00ms的脉冲,第二个所述既定截止点为83.00ms的脉冲。
- 根据权利要求8至10中任一项所述的电刺激装置,其特征在于,所述多变的脉冲间隔的时间介于66.00ms至200.00ms。
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CA3235934A CA3235934A1 (en) | 2022-01-12 | 2022-12-01 | An apparatus for delivering variable pulse |
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WO2020099921A2 (en) * | 2018-11-12 | 2020-05-22 | Dirk De Ridder | Methods and systems for generating composite neurostimulation |
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US20210041953A1 (en) * | 2019-08-06 | 2021-02-11 | Neuroenhancement Lab, LLC | System and method for communicating brain activity to an imaging device |
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US20090082690A1 (en) | 2007-09-25 | 2009-03-26 | Neosync, Inc. | Systems and Methods for Neuro-EEG Synchronization Therapy |
CN101675888A (zh) * | 2008-09-18 | 2010-03-24 | 通用电气公司 | 用于检测具有改变的硬度的区域的***和方法 |
US9308385B2 (en) | 2012-04-06 | 2016-04-12 | Kosivana Holdings Limited | rTMS at harmonics of biological signals |
US20180169372A1 (en) * | 2016-12-21 | 2018-06-21 | Pacesetter, Inc. | Systems and methods for generating pink noise stimulation |
US20190308029A1 (en) * | 2018-04-08 | 2019-10-10 | Conway Ho | Magnetic Stimulation With Variable Pulsed Intervals |
WO2020099921A2 (en) * | 2018-11-12 | 2020-05-22 | Dirk De Ridder | Methods and systems for generating composite neurostimulation |
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