First Brain Implant To Treat Depression Begins Human Trials

By Lauren DeSouza- Master of Public Health, Simon Fraser Public Research University – Canada
https://newdawnscounseling.com/our-providers/

Staff Research and Content Writer

A penny-sized brain implant may change the way we treat depression.
Depression is the most common chronic disease in the world, affecting over 200 million people worldwide. Experts estimate that this rate doubled over the course of the COVID-19 pandemic. In the US, nearly 10% of adults suffer from a depressive disorder each year.
While there are treatments available for depression, they are not always accessible. Patients may lack the time or resources to access medication or counseling for depression. These treatments also do not work for everyone; patients with treatment-resistant depression often do not experience benefits from existing treatments.
U.S.-based neurotechnology company Inner Cosmos is testing a “digital pill” that could transform how we treat depression. This implanted electrode sends electrical pulses to the region of the brain affected by depression. The company believes this may help ease patients’ depressive symptoms.

How does this treatment work?

In this treatment, a small electrode the size of a penny is implanted into the patient’s skull. The implant sends tiny electrical pulses to a region of the brain called the left dorsolateral prefrontal cortex once daily for 15 minutes. The implant stays under the person’s skull and a second piece, the “prescription pod”, snaps onto the patient’s hair once daily to power the device for the 15-minute treatment. Implantation of the device into the skull is a non-surgical, non-invasive procedure.
The left dorsolateral prefrontal cortex controls processes including working memory, abstract reasoning, motor skills, and, most pertinently, mood management. This region of the brain has been found to be underactive in patients with depression. The electrical pulses emitted by the implant can stimulate activity in this brain region, which may help to reduce depression symptoms.
The implant works with a smartphone application that is programmed by a psychiatrist. The psychiatrist can adjust the device to suit the needs of the individual patient. There are sensors in the device that constantly monitor the implant and the patient’s mood and symptoms. The app can use this information to output graphs and share them with the patient’s physicians. This is all done remotely, saving the patient and the physician time and effort, and allowing for monitoring and adjustment in real-time.

How is this device being tested?

Inner Cosmos is performing a clinical trial to test the safety and effectiveness of its implant. This trial is registered on the Clinical Trials website of the National Institutes of Health in the U.S. According to the trial registration, an estimated 20 participants will have the electrode implanted into their skulls in this first human trial of the device. Each patient will have the implant in their brain for up to one year. As of January 2023, one patient has had the device implanted into their brain.

Image from Inner Cosmos via Forbes

This trial is specifically looking at patients with treatment-resistant depression. Patients are defined as having treatment-resistant depression if they had had suboptimal responses to at least two different antidepressant treatments.

In this trial, researchers are using the Montgomery-Asberg Depression Rating Scale (MADRS) to measure the severity of patients’ depression symptoms. Patients are given the MADRS at baseline before the device is implanted, and it will be used at 4-months post-implant to determine if the patient has experienced improvements in their symptoms. The researchers hypothesize that patients given this treatment will show “a significant decrease in depression symptoms” on the MADRS at 4-months post-implant.

What are the takeways?

The field of neurotechnology offers potentially ground-breaking new treatments for many brain conditions, including mental illnesses. The implant created by Inner Cosmos offers a promising new way to treat depression. Their device is the smallest and least obtrusive of these implants and is implanted non-surgically, presenting a simpler, more approachable treatment option for patients. It is especially promising that this treatment would target those for whom other treatments have failed.

It is important to remember that this technology is in very early stages of human trials. More research is needed before we can conclude if this tool is effective for those with depression. Overall, though, this treatment offers hope to those living with treatment- resistant depression that their symptoms could soon be alleviated.

References:

NIH U.S. National Library of Medicine. IpCS in Treatment Resistant Depression. ClinicalTrials.Gov. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05393622

Chopra, Disha. January 2023. Brain Chip by Inner Cosmos Enters 2nd Human Trial to Cure Depression, A Competitor to Neuralink. Analytics Drift. Accessed from https://analyticsdrift.com/brain-chip-by-inner-cosmos-enters-2nd-human-trial-to-cure-depression-a-competition-to-neuralink/

Fink, Charlie. January 2023. Inner Cosmos Raises $10 Million To Treat Depression with BCI Implant. Forbes. Accessed from: https://www.forbes.com/sites/charliefink/2023/01/10/inner-cosmos-raises-10-million-to-treat-depression-with-bci-implant/?sh=1d7ce9dd6584

McBride, Sarah. September 2022. A Startup Has Put Electrodes in a Patient’s Skull to Treat Depression. Bloomberg. Accessed from: https://www.bloomberg.com/news/articles/2022-09-23/brain-technology-startup-puts-electrodes-in-patient-s-skull-to-treat-depression