Bioelectromagnetic medicine

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Bioelectromagnetic medicine deals with the phenomenon of resonance signaling and discusses how specific frequencies modulate cellular function to restore or maintain health. Such electromagnetic (EM) signals are then called "medical information" that is used in health informatics. [1]

Contents

Bioelectromagnetics

Bioelectromagnetics refers to the ability to study live cells, tissues, and organisms that produce electromagnetic fields. Bioelectromagnetism is mostly studied via electrophysiological techniques. [2] [3]

Some of the electrophysiological monitoring methods such as electroencephalography (EEG) and electrocardiography (ECG or EKG) measure the electrical activity of the brain and heart via the installation of electrodes placed on the skin. Recorded evoked potential (EP) amplitudes tend to be low, ranging from tens of microvolts for EEG, millivolts for electromyography (EMG), and about 20 millivolts for ECG. [4] [5] [6]

Other electrophysiological monitoring techniques such as evoked spinal cord potential (ESCP), somatosensory evoked potential (SEP) and SSEP (short-latency SEP) could be coupled with ECG, which then present excitatory ECG-triggered SSEP technique. The amplitude of the EP or evoked response is usually interpreted as the severity of the biological entities' response toward the applied electromagnetic field. Evoked potentials are merely acquired when the applied excitation is more than the excitation threshold of the biological entity. [7] In such cases, excitatory input voltages are applied in different modes, by a stimulation rate of 0.1 to 100 Hz, current stimulation amplitudes of 0 to 200 mA and load resistance of 1 kΩ, which gives 0-200 mV amplitude (in case of constant resistance) and 40 mW electrical power. [8] In some cases, stimulation module of ESCP, SEP, and SSEP techniques is similar to pulsed electromagnetic field (PEMF) generators. [9] [10]

Pulsed electromagnetic field therapy

Development of pulsed electromagnetic field (PEMF) therapy has been problematical because of the lack of scientifically-derived, evidence-based knowledge of the mechanism of action. For example, PEMF therapy used by plastic surgeons the management of postsurgical pain and edema, [11] has been criticized for not having a body of evidence for improving physical function and pain relief. [12]

An examination of why few orthopedic surgeons used electric stimulation for treatment of bone fractures, despite evidence of positive outcomes, concluded that high costs and inconsistent results were the principal reasons. [13]

Pulsed radio-frequency fields (PRF) are a subsection of PEMFs, which then divide to thermal and non-thermal, based on the energy that delivers to the biological object. [14] PRF should not be confused with electromagnetic therapy (EMT), which is also known as radionics. EMT is a form of alternative medicine, which is inspired by holistic medicine logic. Producers of EMT devices claim that they can cure people by "balancing" their discordant energies, according to alternative and holistic medicine references. [15]

Biofeedback

The approach of receiving information (feedback) from the body (bio) is named "biofeedback". [16] Psychiatric disorders, anxiety disorders and neurological disorders are diseases that are targeted by biofeedback. [17] In a type of biofeedback, called neurofeedback, the placement of the patient in the circuit of EMG can reduce symptoms of musculoskeletal disorders. [18] [ unreliable medical source? ][ page needed ]

FDA approved and registered devices

FDA provides two different services when it comes to PEMF devices. When a PEMF device is FDA registered, it means that the FDA is aware of the fact that this device is imported into the USA. On the other hand, FDA approval confirms that a PEMF device has health benefits to treat a specific health condition. [19] Since PEMF devices need to be condition-specific, either of PEMF devices that are inspired by holistic medicine or alternative medicine ideas, which treat a wide range of health conditions, will not be completely approved by the FDA.

FDA labels

The FDA decides which FDA labels to grant to a medical device. There are three main classes of medical devices according to the potential risk that they might have on human health.

Class 1 – Very low-risk devices and drugs. For example, dental floss and bedpans.

Class 2 – Devices with a higher risk than Class 1. For example, condoms and pregnancy tests.

Class 3 – Devices with a very high risk to human health. For example, pacemakers and heart valves. [20]

If the device labeling makes new or remote use of the currently marketed similar devices, the FDA places it into Class 3, which will need premarket approval (PMA) before marketing. Class two medical devices only need to be cleared by the FDA. [21] This means that the FDA will not test them itself. In those instances where a device is substantially equivalent to an existing device, a firm should attempt to obtain 510(k) clearance rather than go for premarket approval. [22] For example, orthofix produces different PEMF devices that decrease markers of inflammation, which has been utilized in clinical studies to treat osteoarthritis, epicondylitis, and rotator cuff tears, [23] but only PHYSIO-STIM I & II MODEL 6000 & 7000 are FDA approved that are used for the treatment of long-bone non-unions fracture. [24] [25] [26] The same story applies to other devices that are produced by Biomove. By this regard, only certain models that are provided by Biomove company, such as Biomove 3000, 5000, are FDA cleared because they are substantially equivalent to the FDA approved device like NeuroMove (NM900 device, Dan Med, Inc). [27]

Allowed specific absorption rate

According to the FDA's criteria for significant risk investigations of magnetic resonance, the specific absorption rate (SAR) that a medical device is licensed to deliver to the body is limited to certain electrical power during a limited time. The SAR for whole body and head is less than 4 and 3.2 Watt per kilogram, which should not exceed 15 and 10 minutes, respectively. In case that body is exposed to a static magnetic field, the amplitude of the magnetic field should not exceed 4 and 8 Tesla for infants and adults, respectively. [28] By this regard, some of the PEMF devices such as MDcure, Aerotel Ltd., (Holon, Israel) and Aerotel Inc. (USA, New York, NY, USA) are categorized as FDA Class-1 therapeutic device since they deliver extremely low-intensity electromagnetic field with nanoTesla amplitude (nT; 10−9) at a set of low frequencies (1–100 Hz). Such PEMF devices must not be confused with EMT devices, which are accused of Class I recall. [29]

A device that has either licensed SAR or standard instrumentation does not approve its marketing. FDA only gives PMA certificates or clearance to medical devices that have a mechanism of action beside a diagnostic/therapeutic efficiency.

Related Research Articles

Magnetic therapy is a pseudoscientific alternative medicine practice involving the weak static magnetic field produced by a permanent magnet. It is similar to the alternative medicine practice of electromagnetic therapy, which uses a magnetic field generated by an electrically powered device.

Transcranial magnetic stimulation Form of brain stimulation using magnetic fields

Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. An electric pulse generator, or stimulator, is connected to a magnetic coil, which in turn is connected to the scalp. The stimulator generates a changing electric current within the coil which induces a magnetic field; this field then causes a second inductance of inverted electric charge within the brain itself.

An evoked potential or evoked response is an electrical potential in a specific pattern recorded from a specific part of the nervous system, especially the brain, of a human or other animals following presentation of a stimulus such as a light flash or a pure tone. Different types of potentials result from stimuli of different modalities and types. Evoked potential is distinct from spontaneous potentials as detected by electroencephalography (EEG), electromyography (EMG), or other electrophysiologic recording method. Such potentials are useful for electrodiagnosis and monitoring that include detections of disease and drug-related sensory dysfunction and intraoperative monitoring of sensory pathway integrity.

Biofeedback Gaining awareness of biological processes

Biofeedback is the process of gaining greater awareness of many physiological functions of one's own body, commercially by using electronic or other instruments, and with a goal of being able to manipulate the body's systems at will. Humans conduct biofeedback naturally all the time, at varied levels of consciousness and intentionality. Biofeedback and the biofeedback loop can also be thought of as self-regulation. Some of the processes that can be controlled include brainwaves, muscle tone, skin conductance, heart rate and pain perception.

Cranial electrotherapy stimulation (CES) is a form of neurostimulation that delivers a small, pulsed, alternating current via electrodes on the head. CES is used with the intention of treating a variety of conditions such as anxiety, depression and insomnia. CES has been suggested as a possible treatment for headaches, fibromyalgia, smoking cessation, and opiate withdrawal, but there is little evidence of effectiveness for many of these conditions and the evidence for use in acute depression is not sufficient to justify it.

Electromyography Electrodiagnostic medicine technique

Electromyography (EMG) is a technique for evaluating and recording the electrical activity produced by skeletal muscles. EMG is performed using an instrument called an electromyograph to produce a record called an electromyogram. An electromyograph detects the electric potential generated by muscle cells when these cells are electrically or neurologically activated. The signals can be analyzed to detect abnormalities, activation level, or recruitment order, or to analyze the biomechanics of human or animal movement. Needle EMG is an electrodiagnostic medicine technique commonly used by neurologists. Surface EMG is a non-medical procedure used to assess muscle activation by several professionals, including physiotherapists, kinesiologists and biomedical engineers. In Computer Science, EMG is also used as middleware in gesture recognition towards allowing the input of physical action to a computer as a form of human-computer interaction.

Mind machine

A mind machine uses pulsing rhythmic sound, flashing light, or a combination of these, to alter the frequency of the user's brainwaves. Mind machines can induce deep states of relaxation, concentration, and in some cases altered states of consciousness, which have been compared to those obtained from meditation and shamanic exploration. Photic mind machines work with flickering lights embedded in sunglasses or a lamp that sits on a tripod above your head or facing you. You then "Watch" with your eyes closed.

Federal Food, Drug, and Cosmetic Act Acts of the United States Congress

The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.

Intraoperative neurophysiological monitoring (IONM) or intraoperative neuromonitoring is the use of electrophysiological methods such as electroencephalography (EEG), electromyography (EMG), and evoked potentials to monitor the functional integrity of certain neural structures during surgery. The purpose of IONM is to reduce the risk to the patient of iatrogenic damage to the nervous system, and/or to provide functional guidance to the surgeon and anesthesiologist.

Bioelectromagnetics, also known as bioelectromagnetism, is the study of the interaction between electromagnetic fields and biological entities. Areas of study include electromagnetic fields produced by living cells, tissues or organisms, the effects of man-made sources of electromagnetic fields like mobile phones, and the application of electromagnetic radiation toward therapies for the treatment of various conditions.

Energy medicine is a branch of alternative medicine based on a pseudo-scientific belief that healers can channel "healing energy" into a patient and effect positive results. Practitioners use a number of names including various synonyms for medicine and sometimes use the word vibrational instead of or in concert with energy. In most cases there is no empirically measurable energy involved: the term refers instead to so-called subtle energy. Practitioners may classify practice as hands-on, hands-off, and distant where the patient and healer are in different locations. Many schools of energy healing exist using many names: for example, biofield energy healing, spiritual healing, contact healing, distant healing, therapeutic touch, Reiki or Qigong.

Georges Lakhovsky was a Russian-French engineer, author, and inventor.

Frequency specific microcurrent or frequency specific microcurrent therapy (FSMT) is the practice of introducing a mild electrical current into an area of damaged soft tissue. Practitioners claim that the introduced current enhances the healing process underway in that same tissue. Critics, such as David Gorski, call proponent's claims of the technique altering body tissue's vibrational amplitude pseudoscience.

FDA Center for Devices and Radiological Health

The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens.

Magnetobiology is the study of biological effects of mainly weak static and low-frequency magnetic fields, which do not cause heating of tissues. Magnetobiological effects have unique features that obviously distinguish them from thermal effects; often they are observed for alternating magnetic fields just in separate frequency and amplitude intervals. Also, they are dependent of simultaneously present static magnetic or electric fields and their polarization.

Radionics Form of alternative medicine

Radionics—also called electromagnetic therapy (EMT) and the Abrams Method—is a form of alternative medicine that claims that disease can be diagnosed and treated by applying electromagnetic radiation (EMR), such as radio waves, to the body from an electrically powered device. It is similar to magnet therapy, which also applies EMR to the body but uses a magnet that generates a static electromagnetic field.

Electromagnetic therapy or electromagnetic field therapy refers to therapy involving the use of magnets or electromagnets.

Pulsed electromagnetic field therapy Treatment of disputed effectiveness using electromagnetic fields

Pulsed electromagnetic field therapy, also known as low field magnetic stimulation (LFMS) uses electromagnetic fields in an attempt to heal non-union fractures and depression. By 2007 the FDA had cleared several such stimulation devices.

Neuromodulation is "the alteration of nerve activity through targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body". It is carried out to normalize – or modulate – nervous tissue function. Neuromodulation is an evolving therapy that can involve a range of electromagnetic stimuli such as a magnetic field (rTMS), an electric current, or a drug instilled directly in the subdural space. Emerging applications involve targeted introduction of genes or gene regulators and light (optogenetics), and by 2014, these had been at minimum demonstrated in mammalian models, or first-in-human data had been acquired. The most clinical experience has been with electrical stimulation.

Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.

References

  1. ↑ Foletti, Alberto (2013). "Bioelectromagnetic medicine: The role of resonance signaling". Electromagnetic Biology and Medicine. 32 (4): 484–99. doi:10.3109/15368378.2012.743908. PMID   23323834. S2CID   25517975.
  2. ↑ Malmivuo, Jaakko (1995). Bioelectromagnetism: principles and applications of bioelectric and biomagnetic fields (PDF). USA: Oxford University Press.
  3. ↑ Rad Jalali, Iman Kamran. "Electronic transmission of antibacterial property into water at extremely low frequency range: A preliminary study". The Journal of Alternative and Complementary Medicine. 24 (5): 5. doi:10.1089/acm.2017.0280.
  4. ↑ Niedermeyer, Ernst (2005). Electroencephalography: basic principles, clinical applications, and related fields (5th ed.). Lippincott Williams & Wilkins. ISBN   978-0-7817-5126-1.
  5. ↑ Leonard S, Lilly (2012). Pathophysiology of heart disease: a collaborative project of medical students and faculty. Lippincott Williams & Wilkins. ISBN   9781469816685.
  6. ↑ Burden, Adrian (1999). "Normalisation of EMG amplitude: an evaluation and comparison of old and new methods". Medical Engineering & Physics. 21 (4): 247–257. doi:10.1016/S1350-4533(99)00054-5. PMID   10514043.
  7. ↑ Alan L, Hodgkin (1952). "A quantitative description of membrane current and its application to conduction and excitation in nerve". Journal of Physiology. 117 (4): 500–44. doi:10.1113/jphysiol.1952.sp004764. PMC   1392413 . PMID   12991237.
  8. ↑ "Neuropack X1, EP/EMG/NCV Measuring System MEB-2300 Desktop System" (PDF). Nihon Kohden.
  9. ↑ Aziza Sayed, Omar (2012). "Evaluation of pulsed electromagnetic field therapy in the management of patients with discogenic lumbar radiculopathy". International Journal of Rheumatic Diseases. 15 (5): e101-8. doi:10.1111/j.1756-185X.2012.01745.x. PMID   23083041. S2CID   24672446.
  10. ↑ Shealy, Norman. "Pulsed Electromagnetic Field Therapy: Innovative Treatment for Diabetic Neuropathy".
  11. ↑ Strauch, Berish (2009). "Evidence-Based Use of Pulsed Electromagnetic Field Therapy in Clinical Plastic Surgery". Aesthetic Surgery Journal. 29 (2): 135–43. doi: 10.1016/j.asj.2009.02.001 . PMID   19371845.
  12. ↑ A., Negm (2013). "Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis". Osteoarthritis and Cartilage. 21 (9): 1281–9. doi: 10.1016/j.joca.2013.06.015 . PMID   23973142.
  13. ↑ Mit Balvantray, Bhavsar (2019). "Electrical stimulation-based bone fracture treatment, if it works so well why do not more surgeons use it?". European Journal of Trauma and Emergency Surgery. 46 (2): 245–264. doi:10.1007/s00068-019-01127-z. PMID   30955053. S2CID   102349148.
  14. ↑ Kenneth R., Foster (2000). "Thermal and nonthermal mechanisms of interaction of radio-frequency energy with biological systems". IEEE Transactions on Plasma Science. 28 (1): 15–23. Bibcode:2000ITPS...28...15F. doi:10.1109/27.842819.
  15. ↑ Crosbie, Smith (1998). ). The Science of Energy – a Cultural History of Energy Physics in Victorian Britain. The University of Chicago Press. ISBN   978-0-226-76420-7.
  16. ↑ Mark S., Schwartz (2017). Biofeedback. Guilford Publications. ISBN   9781462531943.
  17. ↑ Elmer, Green (1977). Beyond biofeedback. England: Delacorte: Oxford.
  18. ↑ Basmajian, John V. (1980). Electrode placement in EMG biofeedback. USA, Baltimore: Williams & Wilkins.
  19. ↑ "Labeling Regulatory Requirements for Medical Devices". FDA.
  20. ↑ Bill, Sutton (2018-11-03). "Overview of Regulatory Requirements: Medical Devices - Transcript". FDA.
  21. ↑ "Overview of Device Regulation". 2019-02-08.
  22. ↑ "Labeling Regulatory Requirements for Medical Devices". U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES.
  23. ↑ "The PhysioStim Device". orthofix. Archived from the original on 2019-07-04. Retrieved 2019-05-30.
  24. ↑ "PMA of PHYSIO-STIM(TM) I & II MODEL 6000 & 7000".
  25. ↑ "Premarket Approval (PMA) of PHYSIO-STIM devices".
  26. ↑ Julianne, Huegel (2018). "Effects of pulsed electromagnetic field therapy at different frequencies and durations on rotator cuff tendon-to-bone healing in a rat model". Journal of Shoulder and Elbow Surgery. 27 (3): 553–560. doi:10.1016/j.jse.2017.09.024. PMC   5835831 . PMID   29174271.
  27. ↑ "Biomove 3000 System 510(k) Number K042650" (PDF). Curatronic Ltd.
  28. ↑ "Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices, Guidance for Industry and Food and Drug Administration Staff".
  29. ↑ "Class 1 Device Recall VIBE".
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