The findings were published Dec. 4 in Nature Medicine and are based on five people with moderate to severe brain injuries. Researchers anticipate the implants could eventually be the first effective therapy for people with chronic brain injuries, if the results hold up in larger clinical trials. About 5 million people in the U.S. experience cognitive deficits after a traumatic brain injury.
“This is the first evidence that you can move the dial for this problem,” Nicholas Schiff, MD, lead study author and a neurologist at Weill Cornell Medicine in New York City, told The New York Times.
The phase 1 trial was led by researchers at Weill Cornell Medicine, Stanford (Calif.) University, Cleveland Clinic, Boston-based Harvard Medical School and the University of Utah, and is based on years of the teams’ research on the brain. The implant involves deep brain stimulation for 12 hours a day, targeting a region of the brain called the thalamus.
Prior research has shown activity in a specific brain circuit underlies many cognitive deficits. The central thalamus typically activates and regulates the brain circuit, though generally becomes damaged after a traumatic brain injury. Deep brain stimulation may restore activity in the central thalamus and thus reactivate the circuit it serves, which was the basis for the study.
Three months after treatment, the five participants scored higher on a standard cognitive test, with improvement ranging from 15% to 55%. Several participants and their family members also reported gains in quality of life improvements, including being able to work and generally feeling more like their former selves before the brain injury.
“I can be a normal human being and have a conversation,” Gina Arata, one of the participants who received the implant 18 years after a car accident left her with chronic fatigue and memory issues, told the Times. “It’s kind of amazing how I’ve seen myself improve.”
Researchers are now planning a phase 2 clinical trial with up to 50 participants.
“There’s a long road ahead, but at least we have a road,” Dr. Schiff said in a news release.
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