Is a CES device right for you? Learn what cranial electrotherapy stimulation is and how it can help you manage depression, anxiety, and insomnia.

What is Cranial Electrotherapy Stimulation (CES)?

Cranial electrotherapy stimulation may improve the lives of people who suffer from a wide range of conditions, from anxiety and depression to insomnia and addiction. While not a cure for any of these conditions, evidence suggests that it may be a telealternative noninvasive treatment that improves sleep quality and helps with behavior modification. This guide reviews the history of cranial electrotherapy stimulators, how CES devices work, and how you can find a CES unit that meets your needs.

CES device being used

What is a CES Device?

A CES machine emits low levels of electricity through electrodes placed on a person’s head. The diodes may be placed behind the earlobes, on the temples, or other places on the forehead and back of the head. An electrical current is delivered via pulses that are shown to stimulate certain areas of the brain. Depending on the condition requiring therapy, the pulses may activate neurotransmitters that can change the person’s mood or aid in breaking habitual behavior.

CES devices currently have FDA clearance to be used as Class II medical devices but do not have FDA approval. You’re able to receive a prescription for a CES unit from a licensed physician as therapy for a number of disorders including neurological disease and mental illness. There are currently 11 CES devices available for sale in the United States.

In the past, many of the conditions that a CES machine may help with were only treated through medication or invasive medical procedures. The devices aren’t meant to cure any disease, but some people find they may help manage symptoms. For those concerned about being dependent on medication for the rest of their lives, this provides an alternative form of therapy that may reduce the need for medication.

History of Cranial Electrotherapy Stimulation

The concept of using electrical pulses as therapy for pain, insomnia, and behavior modification isn’t new. It was first theorized that electrical pulses could help insomniacs in 1902. Two doctors in France began to experiment with the technology while attempting to alleviate sleeplessness in their patients. This paved the way for further advancements in the 1950s in Russia.

The first CES device was brought to market in Russia. Patients received the therapy by having electrodes placed behind their ears or directly on their ear lobes. A tiny electrical current was sent through the diodes to stimulate the part of the brain known as the thalamic region.

At some point, the diodes were placed over people’s eyelids when scientists believed that the current wouldn’t harm the eyes or the brain. Further research suggested it was a potential safety concern, and the eye area is avoided entirely with modern CES devices.

Over the years, researchers noted other potential applications for cranial electrotherapy stimulation. It was tested on individuals suffering from depression to see if it could aid in mood elevation and the reduction of suicidal thoughts. Patients would receive multiple treatments per day, and it could take a while before they displayed any results. Those who continued to receive treatments found that CES helped them sleep better, feel more energetic, and focus more effectively. Later studies showed that cranial electrotherapy stimulation could help patients suffering from addiction.

How Do CES Devices Work?

Neurotransmitters in the brain are responsible for regulating mood, perceiving pain, getting restful sleep, and other important biological functions. People who suffer from some medical conditions may have an imbalance of these vital chemicals. CES devices stimulate the brain in a way that releases more neurotransmitters, such as serotonin, melatonin, and norepinephrine.

Serotonin is a chemical that helps people feel happy, confident, or excited. It’s called the ‘feel-good hormone’ for this reason. Melatonin aids in the body’s sleep process and helps a person feel tired and fall asleep. Other neurotransmitters regulate our habits, pain response, and behavior.

A CES machine emits a very small amount of electricity, and the current is normally administered in a series of pulses. Most people don’t even feel the pulses during their therapy. The effects are cumulative, which means you may not detect a difference in how you feel right away. Depending on their condition or symptoms, have reported an improvement in as little as a day and as long as several weeks.

While CES technology was first developed over 100 years ago, there’s still a lot that scientists don’t know about the brain and how it responds to cranial electrotherapy stimulation. CES units have changed over time, but they’re becoming more popular now that they’ve received clearance from the FDA as an alternative therapy for many conditions.

Hows does a CES Device work

FDA Clearance: What Does this Mean?

FDA clearance isn’t the same as approval, but it's a vital step in the process. An FDA-approved drug or medical device is a treatment that the FDA believes is safe enough to justify any risks that patients take by using it. There's sufficient evidence that it treats the condition it’s received approval for and the potential side effects aren’t likely to be life-threatening.

For a medication or medical device to be cleared by the FDA, it needs to provide a benefit that's similar to an existing treatment that has already received FDA approval. CES machines have received FDA clearance. This means there's enough evidence to suggest that they’re safe to use, and they may help patients manage symptoms of the medical conditions they're cleared for.

Classifying Medical Devices
    The FDA has three main classifications for medical devices: class I, class II, and class III.
  • Class I: 47% of medical devices fall in this category, present minimal harm to the user, and are often simple in design. An example might be an elastic bandage or handheld surgical instruments.
  • Class II:The majority of medical devices fall into this category, including CES devices. Other examples of class II devices include motorized wheelchairs and some pregnancy kits.
  • Class III: These are typically medical devices that sustain or support life or are implanted.

CES units are considered Class II devices as of 2019, which means they’re available for use only if you receive a prescription from your physician. They can’t be obtained over the counter or through online sales unless prescribed, so you need to speak with your doctor about obtaining a device and how to use it properly. You can also use an online telemedicine service to request a device authorization.

Before 2019, the FDA deemed CES units as Class III medical devices, which made them much harder to obtain. Class III devices have a significantly higher risk of causing injury when used improperly and require a physician’s supervision during use. The recent change in classification is a testament to improvements in safety and effectiveness over the past couple of decades, but it’s important to note that CES machines haven't yet gained full FDA approval.

Different Uses of CES Devices

Cranial electrotherapy stimulation may help manage numerous symptoms including headaches, inability to fall asleep, anxiety, depression, and addiction. One study found that it might be useful for alleviating pain for those with Parkinson’s disease. Another study suggested that CES units could be used as an alternative to pharmaceutical medications commonly prescribed to treat depression and anxiety.

A CES machine can be used to stimulate subcortical areas of the brain, including the hypothalamus, thalamus, and pons. Stimulating each area may produce a different effect, such as changing a person’s mood, making them feel more relaxed, deterring unwanted habits, or making them perceive discomfort differently. While cranial electrotherapy stimulation devices are primarily used for assisting people in managing physical discomfort or getting more restful sleep, they could also be useful for behavior modification and improving mood.

Clinical trials involving veterans who returned from Afghanistan and Iraq also showed positive results with CES therapy in the management of traumatic brain injuries, PTSD, and combat-related anxiety. Traumatic brain injuries can cause symptoms such as dizziness, insomnia, and headaches. In a limited study, it was shown that CES may help people manage all three symptoms better than if they received no treatment at all.

CES for Anxiety, Depression, and Insomnia

One study published in the Journal of Pain and Symptom Management evaluated the use of CES brain stimulation to help patients manage anxiety, depression, and insomnia. The study lasted for four weeks, and patients suffering from multiple conditions received regular therapy with a CES therapy device. Key neurotransmitter levels and proteins were tested prior to the sessions, and participants were monitored throughout the study to see if there was any improvement in their hormone levels.

Of the original participants, 92% continued to use the device until the end of the study, and there was a satisfaction rate of 93%. There weren’t any notable side effects throughout the therapy, and each participant was tested again at the end of the study. The results showed an improvement in neurotransmitter and hormone levels associated with mood, sleep, and stress.

Depression, anxiety, and insomnia are commonly treated with medications that restore the balance of neurotransmitters. This can reduce stress, promote feelings of happiness, help people fall asleep faster, and increase the duration of rest. Medications come with unwanted side effects, however, which can worsen peoples’ conditions or reduce their quality of life. In some cases, the side effects make the condition less manageable than if the patients didn’t receive treatment.

A cranial electrical stimulator sends electrical impulses to parts of the brain that regulate hormones. Over time, the body may begin to produce more of the neurotransmitters it needs to feel less tired, manage stress, and feel content or satisfied. The above study suggests that when used along with medication or as an alternative to traditional therapies, a CES machine may help people manage conditions such as anxiety, insomnia or depression.

CES for Behavior Modification

It's believed that CES therapy may help people manage addiction by interrupting the patterns in the brain associated with habit and dependency. This can be beneficial for those who may have become addicted to the very pain medications they’re using to treat their chronic pain. You may be able to manage your pain with a CES machine while reducing the need to use an opiate.

Smokers, alcoholics, and drug users might also use a CES unit to kick their habits. Continued use can interrupt the signals in the brain that create the urge to use an addictive substance and change daily habits. When used under the guidance of a licensed psychiatrist, CES therapy could be helpful in treating a number of other behavior patterns that you’d like to change.

Another use being researched for CES machines is to help people manage ADD or ADHD by deactivating areas of the brain that may interfere with focus and concentration. The routine use of one of these devices may be helpful to some individuals as an alternative to medication.

Conclusion and Considerations

If you’re looking for an alternative method of treating a psychological disorder or insomnia, you might consider cranial electrotherapy stimulation. It’s important to note that results may vary between individuals and that CES units are cleared by the FDA, but you need a prescription to obtain them.

Scientists are still learning how brain electrotherapy works and how it can be used to treat neurological disorders, sleep disorders, and chronic pain. Some studies do suggest that it might help you manage the symptoms of these conditions with or without the use of medication. You should consult your doctor to determine the best treatment plan for you.

FAQs About CES Devices

How do I use a CES device?

To use a cranial electrotherapy stimulation device, you’ll place electrodes on your head in places such as behind your ears, your temples, or if using earclips, on the earlobes. The CES machine emits electrical impulses through these diodes, which are meant to change your brain patterns.

Are CES devices safe?

The FDA has cleared CES devices and classified them as Class II medical devices. This means they’re safe to use when prescribed by a doctor and don’t pose a significant risk of injuries or adverse reactions.

What are the side effects?

Some people report minor discomfort or feeling the electrical current through the diodes. Make sure to report any side effects to your doctor and discuss whether they're manageable.

Do CES devices work?

There are studies that support the effectiveness of CES machines in helping patients manage anxiety, insomnia, and other conditions, but there haven’t been enough studies to prove they work for all people. It’s a good idea to discuss options with your doctor to see if CES devices might be right for you.

What does brain electrotherapy do?

Brain electrotherapy methods such as cranial electrotherapy use electrical diodes to send pulses of electricity at very low levels to areas of the brain that control mood, sleep, pain perception, and behavior.

What’s the difference between CES, TMS, and tDCS?

While the three technologies are similar, the devices work differently. CES devices send electrical pulses through electrodes placed on your head while a TMS unit uses a coil-based system and magnetic fields to alter brain activity. tDCS devices use electrodes just like CES machines, but the flow of electricity is constant, rather than sent as pulses. CES units have received FDA clearance while tDCS units aren’t yet cleared. TMS is FDA cleared for Major Depressive Disorder and OCD, but only available at a clinic and not for home use.

Does electrotherapy work for anxiety and depression?

There are some studies that suggest electrotherapy may help people manage their anxiety and depression as an alternative or in combination with other treatments. It’s important to seek the advice of a doctor about the best treatment plan.

How do I obtain a CES device?

The first step is to get a prescription from a licensed doctor. It’s possible to do this through a telehealth provider such as HelpDetoxMe.com. If you’d like to know more about CES devices and how to obtain one, contact us today.

References/Sources

  1. https://www.cnet.com/health/fda-approved-vs-fda-cleared-whats-the-difference/
  2. https://www.practicalpainmanagement.com/treatments/interventional/stimulators/ces-practical-protocol-thetreatment-pain
  3. https://en.wikipedia.org/wiki/Cranial_electrotherapy_stimulation
  4. https://www.frontiersin.org/articles/10.3389/fnhum.2021.625321/full" target="_blank">https://www.frontiersin.org/articles/10.3389/fnhum.2021.625321/full
  5. https://www.medtechdive.com/news/fda-downclassifies-cranial-electrotherapy-stimulators-for-anxiety-insomnia/569508/
  6. https://www.hindawi.com/journals/pd/2010/569154/
  7. https://www.tandfonline.com/doi/abs/10.1300/J184v09n02_02
  8. https://www.federalregister.gov/documents/2019/12/20/2019-27295/neurological-devices-reclassification-of-cranial-electrotherapy-stimulator-devices-intended-to-treat
  9. https://clinicaltrials.gov/ct2/show/NCT02453347
  10. https://www.jpsmjournal.com/article/S0885-3924(17)30433-5/fulltext
  11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3381625/
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