Category Archives: Inflammation

Clinical trial of Cranial Electrotherapy stimulation in adolescent patient with depression, anxiety and developmental deviation

Vignette # 3:

Justin is a sixteen year old Caucasian male with a history of psychiatric treatment including medication intervention for developmental deviation with a hyperkinetic element. His history of school functioning had been very poor with low motivation to succeed. His father reports that Justin would often experience feelings of anger and anxiety with behavioral acting out. During the initial psychological evaluation he had great difficulty attending to tasks presented to him, was emotionally labile, and on a measure of depression he scored at the 24th percentile, while on a measure of anxiety he scored at the 2nd percentile with present moment (state) anxiety and at the 27th percentile with general proneness (trait) anxiety. On the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Full Scale intellectual functioning was in the Average range (Full Scale IQ = 96) with verbal area functioning in the Low Average range (Verbal IQ = 81) and performance area functioning in the Superior range (Performance IQ = 122).

After thirty days daily usage of at least forty-five minutes with the CES device he was again administered a psychological evaluation. On the same measure of depression Justin scored at the 1st percentile, while on the same measure of anxiety he scored at the 3rd percentile with present moment (state) anxiety and at the 16th percentile with general proneness (trait) anxiety, a noticeable decrease with his levels of depression and trait anxiety. On the WAIS-R Full Scale intellectual functioning was in the High Average range (Full Scale IQ = 111) with verbal area functioning in the Low Average range (Verbal IQ = 88) and Performance area functioning in the Very Superior range (Performance IQ = 139). Higher scores in the Verbal, Performance, and Full Scale areas indicated a gain of more than three standard deviations which by chance alone would occur in less than two in ten thousand cases (p<.0002). He was observed to be much more at ease with a noticeable improvement in his affect and cooperativeness as well as his ability to not only stay on task, but more motivation to do well with tasks. His mother stated that his ability to tolerate difficult situations and tasks was greatly improved as was his mood and that it was much easier and more pleasant to be around him.

Dynamics of the Cranial Electrotherapy Stimulation Devices Market

ces-ultra

With the increasingly stressful lifestyle there is also rise in other types of disorders such as anxiety and sleep disorders. With the lack of sufficient treatments that address these disorders, cranial electrotherapy stimulation comes as an innovative and required treatment.

Cranial Electrotherapy Stimulation (CES) device is a small device that stimulates the cranium and brain with a current less than 4 mA, which cannot be sensed by the patient. The cranial electrotherapy stimulation is approved by the FDA for the treatment of insomnia, depression and anxiety. Besides, it has potential application in the treatment of a number of disorders such as attention deficit hyperactivity disorder (ADHA), obsessive-compulsive disorder, post-traumatic stress disorder (PTSD), cognitive dysfunction, traumatic brain injury, pain, enhancing attention and concentration, and for reducing assaultive behavior.

A relatively large number of the population across the globe is diagnosed with such disorders. A significant portion of the U.S. population is affected by poor mental health, which leads to development of various kinds of mental health disorders. The treatment method is complementary and an alternative of medicine. There are large number of clinical trials currently active, which have proved the CES device as an effective treatment method.

The increasing number of cases of poor mental health with the development of disorders such as depression, anxiety and other sleep disorders is driving the growth of the market. Although animal studies have proved this device to be effective, the adoption of these devices is affected due to lack of strong evidence in humans proving the efficacy of the devices in all or most of the cases. However, there are a number of new clinical trials in the recruiting stage, which may help fill the gap in the market.

Use of Cranial Electrotherapy Stimulation in Hospitals and the Growing Demand of Wearable Type of Devices

There are various types of cranial electrotherapy stimulator devices and they can be broadly classified based on the type of electrode placement, such as invasive or transcranial and non-invasive or wearable. The wearable type is the dominant segment in the market. The wearable type device is user-friendly and does not requires surgical insertion of the electrode. Most of the FDA-approved devices are suitable for the treatment of insomnia, depression and anxiety, as the prevalence of these disorders is increasing, in which depression is the most common and growing disorder in the young population. Since most of these devices are available only in prescribed hospitals and mental health clinics, they have a large scope as end-use segments in the market.

The CES Ultra is one of the three major cranial electrotherapy stimulation devices, namely the CES Ultra by Neuro-fitnesss LLC, Alpha-Stim M and the Alpha-Stim AID by Electromedical Products International (EPI), and the Fisher-Wallace Simulator.

The CES Ultra is most affordable and effective easy to use CES device. You can buy directly from us, Neuro-fitnesss LLC, the manufacturer, without a middleman, and save time and money.

Why Pay More?

A few words of advice if you’re looking to purchase a CES unit: There are only a few FDA approved companies selling CES in the U.S. Here are the companies and their devices:

  • Neuro-Fitness LLC/ CES Ultra
  • Fisher Wallace, Inc./Fisher-Wallace Stimulator
  • Electromedical Products International, Inc./Alpha-Stim

Below is a price comparison table:

ces-devices-prices

Do not be fooled into paying more, because you think more is better. The FDA (Food and Drug Administration) considers all approved CES units to be “substantially equivalent” to each other.

Note: *The CES Ultra is the premier unit on the market. It alone features the original 100 Hz configuration that most of the CES research has been done on. Other units may claim to carry the 100 Hz but no other unit has an accurate rendition of the configuration on which most of the research is based.

WARNING

Do not buy product that are not approved by FDA (The Food and Drug Administration)

You may also find certain “underground” instruments on the market, particularly on the Internet. Contrary to their anecdotal claims, most have no scientific evidence behind them. Many are nothing more than low-cost pulse generators of dubious quality, and have not been fully evaluated for either efficacy or safety. They are not registered with the FDA. Many are billed as “for research purposes only,” and cannot legally be called “medical devices” or make any medical claims. Many are from overseas and are of dubious quality.

Pharmaceuticals NO, Electroceuticals YES

Electroceuticals are a new category of therapeutic agents which act by targeting the neural circuits of organs. The therapy involves mapping the neural circuitry and delivering neural impulses to these specific targets.

ces-electroceuticals

Currently drugs rule the roost. Whatever cannot be treated by drugs is treated by interventions or surgery. Technically, all organs and functions are regulated through brain and nervous system; a circuits of neurons communicating through neural impulses. Even endocrine system is under control of central nervous system by a complex array of feed-back mechanisms. Furthermore, most drugs effect by either acting on final-receptors (neural) or endocrine mechanisms. But all known drugs and of-course surgeries or non-surgical interventions have definite side-effects, because their action cannot be exactly localized to the defective part or organ. In this context, imagine a day when instead of drugs, electrical impulses become the mainstay of medical therapy.
Instead of administering drugs, or doing complex procedures, the physicians may just administer electroceuticals which will target individual nerve fibres or specific brain circuits and be able to treat any condition. In other words, the neural impulses that control the body will be entrained to regain the lost function and reestablish a healthy balance. Thus they could regulate a host of bodily activities; food intake, cardiac activity, pancreatic activity, liver, kidney or spleen functions. They could even control inflammation and set right many pathologies like diabetes mellitus, obesity, hypertension, heart failure, cerebro-vascular and pulmonary diseases.

It is estimated that electroceuticals will become a mainstay of medical treatment over the next two decades, benefiting up to 2 billion people – a quarter of the global population – who are suffering from chronic diseases.
Electroceuticals is a recently coined term for an old therapeutic modality that broadly encompasses all bioelectronic medicine. It incluses any type of electrical stimulation to affect and modify functions of the body; neural implants such as cochlear implants, retinal implants or spinal cord stimulators for pain relief but also cardiac pacemakers and implantable defibrillators. Recently, the field has expanded to include deep brain stimulation and the electrical stimulation of the vagus nerve including cranial electrotherapy stimulation (CES).

CES work because the nervous system and tissues function electrochemically and can be modulated readily by electrical intervention. Low-frequency current effectively targets cell receptors, activating them through frequency matching in a manner similar to that of chemical ligands.

The sensation of pain is transmitted through the body along billions of nerve cells that are designed specifically to transmit messages through electrochemical signals. Physics controls chemical reactions in the body, and most bodily functions can be normalized electrically. It is the application protocol that affects the peripheral pain site directly and accesses the central nervous system by directing the current through the spine. Combining MET and CES addresses all 4 pain pathways: transduction, transmission, modulation, and perception.

The resultant central and peripheral effects of CES include calmness, relaxation, reduced agitation and aggression, stabilized mood, improved sleep, and reduced pain. Results will vary with the exact technology used, the pathology of the disease being treated, the overall health and hydration of the patient.
Therapeutically, electroceuticals score over conventional drugs in a number of ways. Number one, they target neural electrical circuits which are composed of discrete elements; a system of – interconnected cells, nerve fibre network and nerve bundles, thus allowing for precise application of therapeutic effort. The final common pathway of this whole circuit is generation of action potential which itself can be modified allowing for additional control. Thus overall, efficacy increases but side effects decrease because of extreme specificity of response.

Ref>
https://www.sciencedirect.com/science/article/pii/S0019483217308131
https://www.americanveterinarian.com/journals/amvet/2018/july2018/electroceuticals-the-wave-of-the-future-is-now

Clinical Trial of Cranial Electrotherapy Stimulation in Adolescent Patient with Major Depression

Vignette # 2: Melinda, a sixteen year old Caucasian female, had a long term history of depression and had been in counseling without much noticeable success. Melinda reported that she had experienced feelings of sadness for “….as long as I can remember” and when initially evaluated by the psychologist displayed a very flat affect with almost no emotion and a monotone voice. The psychologist was extremely concerned that she might be suicidal because she had reported thoughts of self harm. On a measure of depression she scored at the 77th percentile, while on a measure of anxiety she scored at the 73rd percentile with present moment (state) anxiety and at the 96th percentile with general proneness (trait) anxiety.

On the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Full Scale intellectual functioning was in the Average range (Full Scale IQ = 107) with verbal area functioning in the High Average range (Verbal IQ = 111) and performance area functioning in the Average range (Performance IQ = 107).

After thirty days daily usage of at least forty-five minutes with the CES device she was again administered a psychological evaluation. The psychologist observed a much brighter affect with much smiling and talking as well as her initiating conversation during the session appearing almost as a different person. On the same measure of depression Melinda scored at the 1st percentile, while on the same measure of anxiety she scored at the 2nd percentile with present moment (state) anxiety and at the 9th percentile with general proneness (trait) anxiety.