Tag Archives: cesultra

Transcranial Direct Stimulation v. Cranial Stimulation

It is perhaps time to set the record straight about transcranial direct current stimulation, commonly known as tDCS and the sudden rush to embrace this new technology.

There is a serious misunderstanding which should be done away with at the outset. tDCS is not ECT ( electro-convulsive therapy). We are talking instead about a totally different modality. Further, within that modality, yet another distinction should be made. There is tDCS ( transcranial direct current stimulation) and CES (cranial electrical stimulation) which is based not on DC but on AC ( alternating Current).

Much of the current ( no pun intended) hoo-hah is about tDCS  and specifically the device being marketed by foc.us. It is based on research of a dubious nature and promoted as a new hula-hoop for the mind for gamers and those hoping for a quick cognitive fix.

Though it affects the human condition, the FDA has not intervened to regulate the device, primarily because its sponsors make no medical claims. It has also not been adequately tested for safety, though the amperage, being as low as it is in all probability harmless. Due to the absence of studies, very little is known about the long term effects of tDCS on developing brains.

CES ( cranial electrotherapy stimulation) is also a hand-held electronic device that is simple to use and has no side effects. Unlike tDCS, however, CES, however, has been around for more than half a century, has a substantial body of solid scientific research behind it, as well as an unblemished safety track record. CES manufacturers are registered and monitored by the FDA and are allowed to make claims for their device for the treatment of anxiety, depression, and insomnia. Though no claims are made about enhanced cognitive functioning, results demonstrate gains in that realm as well.

cesultra cranial electrical stimulation

Common sense says that cognition is very much a function of those states. If you are less anxious and depressed and getting a good night’s sleep, your cognitive     functioning improves as well. Conversely, the more stressed out you are, the less able you are to think clearly. It is somewhat depressing as one who has worked in the field for more than 35 years to encounter a discussion on the brain and electrical activity and hear not a word about CES. Incidentally, at a time when our veterans are struggling to find a non-drug solution to PTSD, CES is being currently used exactly for that purpose, being prescribed for active duty personnel returning from the mid-east at the Warrior Combat Stress Reset Program at Ft. Hood, TX, at Ft. Campbell, KY, Ft. Joint Ft Lewis-McChord, WA, at the Bremerton WA Naval Hospital, as well as in combat conditions in Iraq and Afghanistan. When it comes to employing gentle electrical stimulation for the treatment of depression, anxiety, and insomnia as well as an associated upswing in cognitive functioning, using a government regulated modality, CES is clearly the only viable option.

Kids on Drugs (Thanks to Parents and Doctors)

Part I: The Dangers

Part II

Parents and Doctors are often overwhelmed when having to deal with ADHD kids. They often look for a shortcut—prescription drugs. Common brand names include stimulants such as Ritalin, Concerta, Adderall, Metadate, Vyvanse, and Provigil. Use of such drugs has reached epidemic proportions. The figures are staggering:

kids-on-drugs

 

More than 1 in 10 (11%) US school-aged children had received an ADHD diagnosis by a health care provider by 2011, as reported by parents.

o    6.4 million children reported by parents to have ever received a health care provider diagnosis of ADHD , including:

  • 1 in 5 high school boys
  • 1 in 11 high school girls

 

The percentage of US children 4-17 years of age with an ADHD diagnosis by a health care provider, as reported by parents, continues to increase.

o    A history of ADHD diagnosis by a health care provider increased by 42% between 2003 and 2011:

  • 7.8% had ever had a diagnosis in 2003
  • 9.5% had ever had a diagnosis in 2007
  • 11.0% had ever had a diagnosis in 2011

o    Average annual increase was approximately 5% per year

The percentage of children 4-17 years of age taking medication for ADHD, as reported by parents, increased by 28% between 2007 and 2011.

o    Percentage of children taking medication for ADHD was:

  • 4.8% in 2007
  • 6.1% in 2011

o    Average annual increase was approximately 7% per year

The average age of ADHD diagnosis was 7 years of age, but children reported by their parents as having more severe ADHD were diagnosed earlier.

o    8 years of age was the average age of diagnosis for children reported as having mild ADHD

o    7 years of age was the average age of diagnosis for children reported as having moderate ADHD

o    5 years of age was the average age of diagnosis for children reported as having severe ADHD

More US children were reported by their parents to be receiving ADHD treatment in 2011 compared to 2007, however treatment gaps may exist.

o    In 2011, as many as 17.5% of children with current ADHD were reported by their parents as not receiving either medication for ADHD or mental health counseling

o    More than one-third of children reported by their parents as not receiving treatment were also reported to have moderate or severe ADHD

The patterns in ADHD diagnosis and medication treatment showed increases in the percentages overall, however some new patterns emerged between 2007 and 2011.

o    The percentage of children reported by their parents to have a history of health care provider diagnosed ADHD increased for most demographic groups (for example, across racial groups, boys and girls) from 2003 to 2011; however,

o    Between 2007 and 2011, the percentage of children reported by their parents to have a history of a health care provider diagnosed ADHD:

  • Was similar among older teens
  • Decreased among multiracial children and children of other races when compared to black or white children

The number of US families impacted by ADHD continues to increase.

o    An estimated 2 million more children were reported by their parents to be diagnosed by a health care professional with ADHD in 2011, compared to 2003

  • By 2011, 6.4 million children were reported by their parents to be diagnosed by a health professional with ADHD compared to 4.4 million in 2003

o    An estimated 1 million more children were reported by their parents to be taking medication for ADHD in 2011, compared to 2003.

  • By 2011, 3.5 million children were reported by their parents to be taking medication for ADHD compared to 2.5 million in 2003

kids-adhd-drugs

These figures should give pause for consideration. By increasing children’s dependence on pharmaceuticals, they learn that the best and easiest way to deal with their emotional issues is by taking a drug, perfect training for their adult years and an added incentive to graduate to recreational drug use and an increased reliance and dependence on prescriptions as a pathway to health.

ADHD Drug Warnings:

There have been 44 warnings from eight countries (United States, United Kingdom, Canada, Japan, Australia, New Zealand, France and Singapore) warning that ADHD drugs/stimulants cause harmful side effects. These include the following (note that some warnings cite more than one side effect, so the list below may not be equal to the total number of warnings):

  • 13 warnings on stimulants causing heart problems
  • 10 warnings on stimulants causing mania/psychosis
  • 9 warnings on stimulants causing cardiovascular problems
  • 8 warnings on stimulants causing death
  • 4 warnings on stimulants causing hallucinations
  • 4 warnings on stimulants causing depression
  • 4 warnings on stimulants causing violence, hostility or aggression
  • 4 warnings on stimulants causing seizures
  • 3 warnings on stimulants causing agitation or irritability
  • 3 warnings on stimulants causing anxiety
  • 2 warnings on stimulants causing suicide risk/attempts
  • 2 warnings on stimulants causing addiction or dependence

ADHD Drug Studies:

There are 25 studies from five countries (United States, Australia, Denmark, Canada and Italy) showing that ADHD drugs/stimulants cause harmful side effects. These include the following (note that some studies cite more than one side effect, so the list below may not be equal to the total number of studies):

  • 5 studies on stimulants causing addiction/medication abuse
  • 5 studies on stimulants causing heart problems
  • 5 studies on stimulants showing lack of efficacy of the drug
  • 4 studies on stimulants causing stunted growth
  • 2 studies on stimulants causing death
  • 1 study on stimulants causing suicide risk/attempts
  • 1 study on stimulants causing violence
  • 1 study on stimulants causing homicidal ideation
  • 1 study on stimulants causing irritability
  • 1 study on stimulants causing depression
  • 1 study on stimulants causing mania, psychosis and hallucinations

Isn't it time we examined a drug-free alternative? The CES Ultra is exactly that—a safe and effective modality with no negative side-effect

Kids on Drugs ( Thanks to Parents and Doctors) – part 2

Part 2: How CES, the Drug Free Alternative, Can Make a Difference

Part 1

One Parent’s Experience

CES Ultra Improves Sleep, Reduces Anxiety, Irritability, and Depression in 14-year-old Male

We’ve been doing a trial with the CES Ultra the past week. The subject was DS*, our 14 year old with diagnosed insomnia, anxiety, and depression. He used the unit for 20 minutes per day, at bedtime.

I would rate the improvement in apparent anxiety and depression to be significant. Anxieties are no longer a major topic of discussion. DS is starting to leave the house on his own for activities other than school. He’s walked outside for exercise many days since starting the program. Last night he performed with his school orchestra and said he didn’t feel strung out about it like he usually has in the past. He settled down well afterwards, which is a first.

Insomnia has shown moderate improvement. We had hoped for more improvement in that department, but perhaps we will see this continue over a longer term. DS does like to use it at bedtime, finds it easier to fall asleep. He is no longer asking for a prescription for sleeping pills. But still some early-morning wakening, etc.

My DH and I find our son more talkative, less defensive, and quite a bit more mellow in the past week. That is something we have not seen for a long time. Irritability has been markedly decreased … now closer to normal teenage irritability than what we endured before. I suspect the reduced anxiety and reduced depression are contributing to the mellower kid.

Side effects: DS feels dozy after using it. Would not do a treatment just before driver’s ed. No negative side effects otherwise noted.

Our family gives CES an “A” grade and a “thumbs up.” The unit’s positive effect on our anxious, depressed, irritable, insomniac teen has taken a lot of stress off of the entire family. And I must add, finding a psych doc who gave us a free (with consult) week-long trial period on the device was very helpful before making the full investment in purchase, which we plan to do.

* (For the sake of privacy, identities are withheld.)

Brief Research Study

Smith, Ray B., McCusker, Charles F., Jones, Ruth G., and Goates, Delbert T.  The use of cranial electrotherapy stimulation in the treatment of stress related attention deficit disorder, with an eighteen month follow up. Unpublished, 1991 and follow-up in 1993.

This study compared the effects of 3 randomly assigned CES devices which had marked differences in electrical stimulation parameters, in the treatment of stress related attention deficit disorder in 23 children and adults, 9 males, 14 females, 9 – 56 years old (average 30.96) with an average education level of 10.56 years. All had been diagnosed as having generalized anxiety disorder (61%), and/or depression (45%), and/or dysthymia (17%). 8 had a primary diagnosis of ADD. CES treatments were given daily, 45 minutes per day for 3 weeks. All 3 CES devices were equally effective based on Duncan’s Range test in significantly (P<.001) reducing depression as measured on the IPAT depression scale (mean of 19.38 ± 8.44 pretest to 13.19 ± 7.00 post test), state and trait anxiety scales of the STAI (mean state anxiety was reduced from 39.95 ± 11.78 pretest to 29.76 ± 6.99 post test, and the mean trait anxiety was reduced from 43.90 ± 11.31 pretest to 32.19 ± 7.50 post test), and in increasing the Verbal pretest (mean of 99.38 ± 13.20 to post test of 107.50 ± 14.13), Performance (mean of 107.4 ± 15.05 to 126.6 ± 14.2 ), and Full Scale I.Q. scores on the WISC-R or WAIS-R IQ tests (mean of 103.2 ± 13.7 to 117.6 ± 14.28). The authors concluded that in the unlikely event that our findings are the results of placebo effect alone, a CES device, retailing at approximately $795, would still be a relatively inexpensive and apparently reliable treatment for such a debilitating disorder as stress related ADD. On 18 month follow up, the pts performed as well or better than in the original study, the Full Scale IQ had not moved significantly from where it was after the first 3 weeks of treatment, the Performance IQ fell back slightly, while the Verbal IQ continued to increase. There did not seem to be any pattern of addiction to or over dependence on the CES device. There was no side effects except for 1 pt who cried during treatments, and 1 who was sore behind the ears when the electrode gel began drying out.

The cornerstone tenet of medicine is “Do no harm.” Don’t you owe it to your child to try a safe, effective, non-invasive approach before turning to drugs? Consider the CES Ultra.

Another Therapist Reports: CES Intervention Diffuses Anger, Decreases Hyper-Irritability, & Improves Health of 21-year-old Female College Student after Other Therapies Fail.

CES being used in pain clinics

CES units were becoming more widely used in pain clinics at the dawning of the 21st century. The clinics typically do not wait for pain studies to be completed, but simply try CES with their patients to see what effect they can observe, then compare it with their historical experience with those same types of patients. A typical such clinic is one just outside Dallas, Texas. A nursing assistant puts CES electrodes on patients as they enter the waiting room to await their turn with physicians or other therapists. The wait can vary from a few minutes to a half hour, depending on the patient load at a given time. The patients complete a 10 point self rated pain score prior to receiving CES. When they are called into treatment by the treatment staff, the CES is removed, the amount of time they were on the device is recorded, as a post CES self rated pain score if obtained.

The clinic has become so enthusiastic about the results, that this protocol has become a permanent part of their core treatment program. They now enthusiastically prescribe CES home units for their large number of patients who now request them, and the staff reports their clinic is much more effectively treating chronic pain than they were previously.

Pain clinic treatment results have been published, however. An interesting CES study was completed in a pain clinic near Bombay, India, in 2001. It was an open clinical trial of CES, used alone as a treatment of pain patients who had been refractory to all other previous efforts of treatment of their pain at the clinic. They were given CES treatments one hour per day, 5 days a week, for three weeks. They were asked to rate their pain level on a VAS scale of 0 to 10, with 10 being the most intense pain. Following treatment their mean self reported pain level had been reduced by 62%. Analyzing the data for individual patients it was found that 15% of the patients did not respond to the treatment, 30% gained total relief, while the remainder of the patients claimed significant relief ranging from 33% to 94%.

CES (Cranial Electrotherapy) Studies of Cognitive Function

Executive Summary. Thirteen studies, in which a total of 648 patients with various types of cognitive dysfunction were treated with cranial electrotherapy stimulation (CES), were combined statistically in order to get a more confident look at the effectiveness of CES for treating this condition. While many of the studies were of the classic double blind protocol, others used either the single blind or open clinical trial. The result of the analysis showed that the overall effectiveness of CES was 44% improvement.

In most of the studies, cognitive confusion was but one symptom within a larger syndrome. For example, in most of the studies, substance abuse was the presenting syndrome, while in three of the 13 studies, fibromyalgia was the presenting syndrome. And while all presented symptoms of cognitive confusion of some type, it is obvious from the above secondary analysis, that the cognitive dysfunction among the substance abuse patients was very likely of a different, physiological etiology than that of the fibromyalgia patients, who may have been experiencing cognitive distraction due to the stress of the unrelenting pain of their condition.

Researchers earlier received a strong impetus to study CES in substance abuse patients when in the 1970s it was found that the abstinence syndrome, including such features as depression, anxiety and insomnia, was seen to come under control very quickly with CES. Serendipitously it was also discovered that what had up until the 1980s been termed “permanent brain damage” in these patients responded to three weeks of CES treatment by bringing these patients back within the normal functioning range.

A word about the study types. In the open clinical study, the patients know they are being actively treated for their level of cognitive functioning, the clinicians know who is being treated, and the statistician who summarizes the study data also knows, since there is only one group of patients.

In the single blind study, the patients do not know which are getting treated and which are getting sham treatment, but the clinician providing the treatment knows which are the treated patients. In the single blind study, the clinician doing the post study evaluation of the patients is often blinded to treatment conditions when he completes his evaluation. The statistician is usually blinded also, so that he is given two sets of scores to compare, and doesn’t know which group received the treatment. This study design was used earlier on before treatment blinding devices came on stream. In such studies, the treatment was administered sub sensation threshold, in which the clinician turned up the current intensity until the patient just felt it, then turned it back down until the patient said he could no longer feel the stimulation. At that point, the clinician either left the current at that level or turned the unit off (down to, but not including the final click). Because both the patients and the statistician are both blind to the study conditions, some authors have unwittingly published this design as a double blind experiment. But that term is generally reserved for the true double blind experimental design as described next.

The double blind study, the gold standard of science, is usually confined to studies in which neither the patient nor the clinician knows who is being studied. Those designs became available when a double blinding box could be inserted between the patient and the CES device. The double blinding box often had three, four or more settings in addition to a “0” setting in which current flowed freely between the CES unit and the patient. Among the other settings available, some passed current to the patient and some blocked it entirely. The clinician would begin the double blind treatment session by setting all double blinding boxes to the “0” position, would connect the patient to the CES electrodes, turn the current up slowly until the patient signaled he could just feel it, then reduce the stimulus level until the patient signaled that he could no longer feel it. At that point, the clinician set the double blinding box to one of the other settings available and left the patient on the device for 30 minutes to an hour, not knowing who was receiving actual treatment..

Interestingly, in a good double blind experimental design, such as was the case in the majority of those reported in the table, the persons who were responsible for measuring or rating patient improvement were also blind as to whom was treated, as was the statistician who was given anonymous groups of data to analyze. Note that, in effect, that makes such studies quadruple blind, but that term is not used in science.

In the crossover design, half the patients get treated the first week or two of the study, while the other half receive sham treatment. In the second half of the study, the formerly treated patients now receive sham treatment while the formerly sham treated patients receive treatment. If the crossover does not involve a sham treatment condition, then the crossover study is treated as an open clinical trial where all patients and staff know who is being treated at each cross of the study. That design is often referred to as a study with “wait in line” controls, in that the patients waiting to begin treatment are tested before and at the end of the waiting period before going into treatment. That is thought to control for environmental factors such as unusual stressors on the 10 O’clock news, any local dramatic weather changes, and so forth.

By Ray B. Smith, Ph. D.