North Carolina

Triangle researchers to test PTSD treatment with $2 million federal grant

A Triangle research institute has received a $2 million grant from the U.S. Department of Defense to test a medical procedure to treat post-traumatic stress disorder.

RTI International will lead the first randomized, controlled trials of a procedure that involves injecting an anesthetic into a nerve tissue center at the base of the neck to treat PTSD patients. Researchers says the procedure, called Stellate Ganglion Block, has the potential to quickly relieve PTSD symptoms.

The goal is to block the sympathetic nervous system, commonly known as “fight or flight,” to relieve the physical stress associated with recurring distressing memories and dreams of a traumatic event. Other PTSD symptoms include avoiding situations that might remind a person of the traumatic event and increased emotional arousal.

Stellate Ganglion Block is not being proposed as a cure for PTSD, only as a way to alleviate symptoms, said Kristine Rae Olmsted, behavioral epidemiologist at RTI and co-investigator on the study.

“While the memories don’t go away, what does go away is the nervous system’s response to those memories,” Rae Olmsted said. “It does not erase memories. It helps people view those memories with less anxiety.”

Three military hospitals were chosen to participate in the study: Womack Army Medical Center at Fort Bragg, Tripler Army Medical Center in Honolulu, Hawaii, and Landstuhl Regional Medical Center in Landstuhl, Germany.

The three-year study will enroll 250 active-duty military patients from the Army hospitals who are diagnosed with PTSD. Rae Olmsted said the three medical centers were chosen because they are already using Stellate Ganglion Block on a limited basis to treat PTSD.

The procedure has been used for about 100 years in treating chronic pain of the limbs. Rae Olmsted said the only evidence that it relieves PTSD symptoms in academic literature is anecdotal, so an important goal of the study is to establish its effectiveness.

PTSD is a complex issue that effects each person differently, and Rae Olmsted said experts do not know how long each injection will relieve symptoms. According to the anecdotal evidence, one injection is enough for some, while others need multiple shots over time.

Dr. Michael Bartoszek, chief of the Womack Interdisciplinary Pain Medicine Center, uses Stellate Ganglion Block to treat about 25 patients with PTSD a month.

He said it is a low-risk injection, and has been practiced for years with very few negative side effects.

Bartoszek said he uses an ultrasound to locate the nerve cells and inserts ropivacaine, a numbing agent that lasts about eight hours. But it’s a quick procedure, and a patient can walk out of the clinic on his own within a half hour.

During the study, participants will receive two injections, two weeks apart, and mental health assessments will be conducted at weeks 4, 6 and 8. There will also be a placebo control group that will receive injections of saline.

The study will include a qualitative component to gather impressions of the procedure from the patients, their families, behavioral therapists and psychiatrists.

Study will be “good test”

There can be a lot of stigma associated with seeking treatment for PTSD, and military members often are concerned about how it might impact their careers, Rae Olmsted said.

She believes this fast, relatively painless procedure might draw more service members into treatment. And as a result of the Stellate Ganglion Block, they might be more receptive to other treatments, such as exposure therapy and the traditional talk-based, psycho-therapy.

Denise Sloan, associate director of the National Center for PTSD’s Behavioral Science Division in Boston, is not involved in RTI’s study but has heard of the procedure.

“The data available is pretty limited,” Sloan said. “It’s concerning to me that they don’t have a hypothesized mechanism as to why this would work.”

Sloan also expressed concern that Stellate Ganglion Block has been used, even on a limited basis, at these Army medical centers without the results of a randomized, control study – like the one RTI will conduct.

“We do need to identify alternative treatment processes,” Sloan said. “This study is really going to be a good test.”

Sloan treats military veterans with PTSD through traditional therapy methods over 12 sessions. Those who are motivated and do the assignments between appointments make the most progress battling their symptoms, she said. But one third of patients drop out, and Sloan said she doesn’t always know why.

“A lot of people with PTSD probably would like a pill,” she said. “Instead they have to do a lot of hard work to get treatment benefits. If they could find a medication that worked, it would be a well-received.”

Knopf: 919-829-8955