Long Island researchers are betting that a bioelectronic device inserted into the ears of World Trade Center first responders could blunt post-traumatic stress disorder suffered over two decades.
A two-year, $700,000 grant from the National Institutes of Health and the Centers for Disease Control and Prevention will fund a pilot clinical trial conducted by the Feinstein Institutes for Medical Research in Manhasset.
Rebecca Schwartz, an associate investigator at Feinstein Institutes, said that while some first responders traumatized by the Sept. 11 attacks are seeking mental health treatment, "many are not."
In an eight-week randomized double-blind study, 20 World Trade Center first responders will use a device that sends electronic stimulation to the vagus nerve via the ear, while 10 others would use an inactive device.
Schwartz said the trial is designed to see if "there's support for our hypothesis" that the device can provide relief. If successful, the pilot trial would be expanded to a larger trial for World Trade Center first responders.
"You could see how this could extend to multiple different types of populations, including military veterans," said Schwartz, who is also associate professor in occupational medicine, epidemiology and prevention at Northwell Health.
Another researcher on the project, Theodoros Zanos, assistant professor at the Institute of Bioelectronic Medicine at the Feinstein Institutes, said that enrollees in the trial won't feel the electronic impulses sent to their vagus nerves during twice daily 15-minute sessions.
Zanos said that the vagus nerve — Latin for "wandering nerve" — is the longest of the 12 cranial nerves and connects the brain to essential organs, including the heart, lungs and gut.
The vagus nerve, which is "critical in maintaining homeostasis" in the organs, has become a focal point of researchers exploring whether such neuromodulation can be used to treat epilepsy, depression and other maladies, he said.
The "gold standard" for treating post-traumatic stress disorder has been prolonged exposure therapy, Schwartz said.
That intensive treatment requires patients to "engage with their trauma" and commit to weekly sessions typically lasting an hour or longer.
"People have many other things competing in their lives," she said. That makes a device offering simple, at-home treatment attractive.
"We don't see it as something to cure PTSD, but as something to reduce symptoms," Schwartz said.
Volunteers for the study initially will be recruited around year's end from the Northwell Health Queens World Trade Center Health Program in Rego Park.
The noninvasive, wired devices, which look roughly like the earbuds widely used with mobile phones, are made by San Francisco-based startup Nēsos.
Zanos said Nēsos devices have been used in clinical trials to treat postpartum depression as well as rheumatoid arthritis, an inflammatory disease.
"There's a tight correlation between inflammation and PTSD," he said. "Inflammation can play a role in the progression of PTSD."
The Vagus Nerve and Its Connections
--Also known as the "wandering nerve";
--Longest of the cranial nerves, reaching to the colon;
--Connects to the heart, lungs and digestive tract;
--Actually two nerves, the left and right vagus nerves;
--Plays a role in regulating digestion, mood and heart rate;
--Researchers are studying the vagus nerve as a path to treat maladies including epilepsy, depression, tinnitus, rheumatoid arthritis, inflammatory bowel disease and post-traumatic stress disorder.