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Brain Stimulator Device Cleared for Depression, Insomnia

Cervella system

Cervella system (Innovative Neurological Devices)

28 Mar. 2019. A device sending weak electric impulses into the brain from headphones is authorized by the Food and Drug Administration to treat depression, anxiety, and insomnia. The Cervella system, made by Innovative Neurological Devices in Carmel, Indiana, will be officially launched today at a meeting of the Anxiety and Depression Association of America in Chicago.

The Cervella technology incorporates principles of cranial electrotherapy stimulation, a form of treatment for neurological disorders that sends a mild electric current into the brain to stimulate neurons for relieving those conditions. The system uses noise-cancelling headphones, with conductive electrodes fitted into the earpads. Patients can control the intensity, frequency, and duration of treatments with an accompanying smartphone app, although typical treatment sessions run about 30 minutes. The app also stores a history of treatments, which the user can share with health care providers.

Innovative Neurological Devices does not indicate if it conducted clinical studies of the Cervella device. However, the company cites a number of published clinical trials showing the efficacy of this non-invasive type of treatment for insomnia, depression, and anxiety, as well as drug abuse treatment and cognitive dysfunction, with improvement rates ranging from 44 to 62 percent.

In addition, a post-marketing trial of Alpha-Stim Technology, a similar cranial electrotherapy stimulation system, among 115 participants with anxiety and depression showed participants receiving the treatments were less likely to experience anxiety and depression than a comparable group using similar equipment, but receiving no electronic stimulation. And an earlier meta-analysis of clinical trials testing cranial electrotherapy stimulation showed the treatments were more likely to help people with anxiety, insomnia, and conditions labeled as brain dysfunctions, but not for headache or pain relief.

FDA requires a prescription for the Cervella system, and considers it a Class 3 medical device, defined as those that “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.” Included in Class 3 devices are heart pacemakers and breast implants. The agency cleared Cervella under its 510(k) pathway for premarket notification. Under 510(k), medical device developers need to show their systems are “substantially equivalent” in safety and efficacy to current devices on the market.

A selling point for the Cervella system is its resemblance to ordinary-looking headphones, which makes it appear that the user is listening to music or other audio content. “We hope that by incorporating treatment electrodes into a noise-cancelling headset, patient compliance will significantly increase and, consequently, treatment outcomes will improve,” says Bart Waclawik, CEO of Innovative Neurological Devices in a company statement. “Also, by making the Cervella device appear indistinguishable from ordinary over-ear headphones, patients will have the freedom to use the device in anxiety-inducing situations without curious looks from onlookers.”

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