Loading...

Cervella FDA-Cleared Cranial Electrotherapy Stimulator

Patient Information

What is Cervella?

 

 

Cervella is an FDA-cleared medical device for treatment of anxiety, depression, and insomnia. The device is powered by an internal rechargeable battery which provides a very low-level current to the patient’s cranium via a pair of conductive electrodes incorporated into ear pads of over-ear noise-canceling stereo headphones. Cervella is controlled via an app installed on patient’s smart device (e.g. smartphone). The patient uses the app to adjust the intensity level, frequency, and duration of the treatment. The app also allows the patient to automatically store the treatment history for review by the patient’s healthcare provider. During treatment, which typically lasts 30 minutes, patient can listen to music via a dedicated Bluetooth connection or use the active noise reduction feature of the headset. In short, Cervella can be used during school, work, study, or play.


How do Cranial Electrotherapy Stimulators work?

 

Cervella is a type of Cranial Electrotherapy Stimulator (CES). Cranial Electrotherapy Stimulators transmit small pulses of electric current across patient’s brain via a pair of conductive electrodes placed on patient’s forehead, mastoid process area or ear lobes. CES devices have been in existence for several decades and are cleared by the FDA for treatment of insomnia, depression, and anxiety. They exhibit good efficacy and have no significant contraindications. CES devices present a very good alternative to drug therapies, especially for patients that respond poorly to anti-depressant drugs or experience significant side-effects with drug-based therapies. CES can be used in conjunction with CBT therapies making it an excellent adjunct device.

 

According to clinical and research studies, the micro current has several effects on the brain: it affects the Default Mode Network (DMN), endogenous brain oscillations, and change in neurotransmitter levels such as Serotonin. The efficacy of cranial electrotherapy stimulation for treatment of anxiety, insomnia, and depression is well demonstrated and documented through numerous clinical trials conducted over several decades. 

During a treatment session, which typically lasts 30 minutes, patients suffering from anxiety, insomnia, and depression will experience reduction of anxiety immediately post-treatment and improved sleep patterns (insomnia reduction). Longer-term use has been clinically validated to have a positive effect on reducing patient’s depressive mood.


How does Cervella compare to drug-based therapies?

 

There are several advantages of using Cranial Electrotherapy Stimulator (CES) devices such as Cervella vs. drug-based therapies ( especially Selective Serotonin Reuptake Inhibitors -SSRIs). 

First, Cervella is quite effective, especially for treatment of Anxiety (and often accompanying insomnia). According to 38 clinical trials, the average improvement rate for patients suffering from anxiety and comorbid depression for CES is approaching 60% as compared to approx. 20%-30% for various types of SSRI drugs.

Second, unlike antidepressant drugs, there are no serious side-effects from using CES, and the Cranial Electrotherapy Stimulation is not addictive or habit-forming. In 2007, the FDA has mandated the use of black-box warnings for antidepressant drugs in  young adults (18-24 years old) to warn patients and physicians about an increased risk of suicidal ideation and behavior in teens and young adults. Cervella, like any CES device, does not have any significant side-effects and can be used (with adult supervision) by teenagers and adolescents. In sum, CES devices are especially suitable for patients who either respond poorly to SSRIs (ineffective treatment), or exhibit significant side-effects with antidepressant use.

Lastly, CES devices can be also used as an adjunct therapy or combined with other non-drug therapies ( e.g. Cognitive Based Therapy) in order to maximize the overall chances of successful treatment.


What makes Cervella different from other CES devices available on the market?

 

Cervella is the world’s first and only Cranial Electrotherapy Stimulator with patent-pending proprietary
conductive treatment electrodes that have been seamlessly integrated into a stereo headset allowing patients to receive treatment during study, work, or play. Other CES devices all use traditional electrodes (placed conspicuously on patient’s forehead or clipped to earlobes) relegating the use of the existing products to patient’s home or doctor’s office. Unfortunately, anxiety attacks can and often do occur in public. Cervella is not easily distinguishable from ordinary over-ear stereo headphones, which makes it suitable for treatment outside of the privacy of patient’s home. In sum, Cervella is designed to fit into a patient’s lifestyle, not the other way around.

Furthermore, Cervella is the first and only CES device that is managed through an App on a smart device. This feature allows for automated treatment data recording, treatment reminders, and cloud integration. It also gives the patient an option to easily share treatment data with his or her health provider in order to better manage the treatment plan.


How do I setup and operate the Cervella device?

Please watch the following video and read your Owner’s Manual completely prior to use.

 


 

Patient Brochure

Download Patient Brochure

If you would like to learn more about the Cervella or share the information with your healthcare provider, please click on the button below to download a PDF copy of the patient brochure.

Cervella Patient Brochure

Purchasing FAQs

Medical FAQs

Operation FAQs