Best CES Device to Help with Depression
Update: December 20, 2019
The Food and Drug Administration (FDA) has reclassified CES devices intended for the treatment of anxiety and/or insomnia from Class III to Class II medical devices. CES devices intended for the treatment of depression will remain Class III and need to file a premarket approval application (PMA) to retain clearance for depression. This article has been updated to reflect those changes.1
Cranial electrotherapy stimulation (CES) is a form of FDA-cleared cleared treatment for depression, anxiety, and insomnia. Many patients experience improvements to mental wellness after as little as one treatment. However, what’s the best CES device for depression in particular? In this blog post we will go into a brief background on depression and what the FDA reclassification means for CES devices on the market.
What is Depression?
Before we dive into the benefits of Cranial Electrotherapy Stimulation (CES), it’s best to define what depression actually is. We all have rough days and feel downcast from time to time – that’s normal human behavior. However, emotional pain, distress, loneliness, and an inability to find joy that lingers every day are often symptoms linked to depression. These symptoms are toxic to our mental wellness and overall outlook on life. Most typical treatment methods include therapy, social engagement, mental distractions, and select drugs. However, with CES technology, a new, effective, and completely safe alternative is possible.
Serotonin, a naturally produced chemical in the body, is a crucial neurotransmitter (relays messages across neurons in the brain) that influences our brain. Researchers believe that an imbalance in serotonin levels effects mood and can lead to depression. This imbalance may happen for a number of reasons, whether it be low serotonin production in the brain, low levels of tryptophan, the chemical precursor to serotonin, or even a lack of receptor sites for serotonin. Unfortunately, even though most scientists believe serotonin deficiency is involved in depression, there currently exists no way to measure serotonin levels in a living brain. As a result, there are no studies conclusively revealing that in cases of depression there are shortages of serotonin in the brain. However, as serotonin levels can be measured in the blood, it is known that in people who suffer from depression, serotonin levels are lower than normal. It remains unknown if blood levels of serotonin account for the brain's level of serotonin.2
How do antidepressant medications work? SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin and norepinephrine reuptake inhibitors) are commonly prescribed types of antidepressant medications. Though how they work is not fully known, they are believed to increase serotonin levels in the brain. The medication is meant to block the reuptake of serotonin by neurons, increasing the levels of the neurotransmitter available in the brain.3,4 However, if you recall we previously mentioned that the levels of serotonin in the brain can not be measured. Therefore, even though an increase in serotonin levels can improve symptoms of depression, scientists still do not know exactly how they work.
FDA Reclassification of Cranial Electrotherapy Stimulation (CES)
Effective December 20, 2019, CES has been reclassified by the Food and Drug Administration. In short:
- The FDA is reclassifying Cranial Electrotherapy Stimulation (CES) devices, intended to treat anxiety and/or insomnia from Class III to Class II, a lower risk category.
- For CES devices intended to treat depression, the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) is required.
What does this mean for CES devices? CES as a technology retains FDA clearance for anxiety and insomnia (Class II) as well as for depression (Class III). However, in order for a device to market itself as FDA cleared for depression, the manufacturer must run a new study and submit a Premarket Approval (PMA) that shows the safety and effectiveness of the device in treating depression. Due to the reclassification and this new requirement of a study be completed, there currently is no best CES device for the treatment of depression. Until these studies are completed and the results published we will not know how these devices effect depression.