Dr. Sheth said the first patient, given the device in March 2020, “is remarkably well” now, maintaining a relationship and becoming a father. To test for a placebo effect, researchers gradually stopped stimulation to one brain region without the patient knowing when. His depression “got worse and worse” said Dr. Sheth, until he needed “rescue.” After stimulation restarted, he improved, suggesting the effect “is definitely stimulation-related.”
Several months ago, Sarah needed a rescue too. Shortly after entering a study phase where the device is either turned off or left on for six weeks without the participant knowing which, “the suicidal thoughts were back,” Sarah said. Her family tried to get her hospitalized, but hospitals were full. “Things were really bad,” Sarah said.
“She did have a very severe worsening of her depression,” said Dr. Scangos. She said she couldn’t disclose whether stimulation had been off or on, but said a device company technician was sent to Sarah’s home to “make a rescue change.”
Afterward, Sarah said, she improved again.
Over the year, the number of times a day that Sarah’s device has detected depression-linked brain activity and delivered stimulation has decreased somewhat, but is still substantial, Dr. Scangos said. Still, some days Sarah doesn’t need the maximum amount the device is set to provide: 300 times or 30 total minutes daily. (It automatically stops around 6 p.m. because evening stimulation made her too alert to sleep.)
Longer-term and more detailed data on Sarah will be published later, said the researchers, who have two other participants so far.
The device is intentionally tuned so Sarah cannot feel the stimulation, but she believes she knows that it’s occurred because she subsequently develops a sense of “emotional distance” that keeps negative feelings “compartmentalized,” she said.
Also, “I feel alert,” she said. “I feel present.”
That’s “a really good sign,” said Dr. Dougherty, who is considering using a similar approach for depression and possibly addiction. “The emotions are still there, but instead of sticking like mud, it’s running off like water.”