PTSD treatment getting scrutiny in clinical trials at thre military hospitals

Dec. 05--It only takes about a minute for Dr. Michael Bartoszek to inject a local anesthetic into a bundle of nerves in a patient's neck.

But the relatively simple procedure can have a big impact on troops suffering from post-traumatic stress.

Bartoszek, a doctor at Womack Army Medical Center, said the treatment -- known as a stellate ganglion block -- can reduce anxiety, halt nightmares and stop the hyper-vigilance associated with PTSD.

The effects are near instantaneous, he said. And they can be long-lasting.

But while Bartoszek is sold on the procedure -- he's performed 350 for Womack since 2013 -- the larger medical and scientific community is not.

That's where a new clinical trial, underway at Womack and two other military hospitals, comes in.

At Fort Bragg, Tripler Army Medical Center in Hawaii and Landstuhl Regional Medical Center in Germany, officials are hoping to gather data on at least 240 patients to provide the first scientific proof of the procedure's efficacy as a PTSD treatment.

The trial involves two procedures, spaced two weeks apart, and two months of monitoring, which includes assessments and focus groups for the patient and family members.

The bulk of the trial participants are expected to come from Fort Bragg, which has one of the busiest and largest military medical centers.

"This is where the soldiers are," Bartoszek said. "Fort Bragg is very important for Army medicine and the Army as a whole. That makes us the prime site for this."

Since the trial opened in June, not all has gone as expected.

Bartoszek said the hospital has had trouble recruiting participants.

Many are concerned, he said, that they will be among the one-third of participants to receive a placebo.

"The study itself has been fine," Bartoszek said. "The biggest challenge is convincing folks to participate. Soldiers are hesitant to risk not getting the treatment they believe might calm their symptoms."

Bartoszek has accounted for roughly half of all stellate ganglion block procedures done at Womack since 2011, when a predecessor introduced the treatment to local troops suffering from PTSD.

Over that time, the hospital has treated many PTSD sufferers, repeating injections as needed.

Bartoszek said the results have been extremely positive.

"It's continued to do well," he said. "People notice the difference."

A previous study conducted with 166 patients at Womack found more than 70 percent "had a clinically significant improvement" to their symptoms that persisted for months.

Officials believe that by administering anesthetic to the stellate ganglion -- a cluster of nerves related to the sympathetic nervous system found in the neck -- they can affect the part of the body that helps control pain, body temperature and the manifestations of post-traumatic stress.

In effect, the procedure reduces nerve growth, limiting the body's "fight or flight" response.

Bartoszek has described the treatment as helping to bring veterans back to a normal range of alertness.

Veterans suffering from post-traumatic stress may always be on high alert, he said. A stellate ganglion block doesn't remove their alertness. But it resets the range.

That can often make veterans feel less agitated and less likely to be quick to anger. And that, in turn, can open them up to more traditional treatments.

The lack of a prior extensive clinical trial is part of the reason the procedure has yet to gain wide acceptance as a treatment for PTSD.

Womack has been an early adopter of the procedure. But it's still only offered in four military hospitals -- Womack, Tripler, Landstuhl and Walter Reed National Military Medical Center in Bethesda, Maryland.

"We've done it a bunch of times, hundreds of times," Bartoszek said. "In the retrospective, it's safe. But in the world of science, that's not enough."

If successful, the doctor said he expects to see more use of the treatment, in and out of military hospitals.

"Insurance companies will have a hard time saying 'No' if there is medical evidence," Bartoszek said. "If the study shows that it's helpful, there are very few barriers to improving access."

A stellate ganglion block itself is not new to the medical community. But it is typically used to treat pain, specifically a disorder known as chronic regional pain syndrome, an uncommon form of chronic pain that usually affects an arm or a leg.

It wasn't until 2007 that a Chicago anesthesiologist made the first link between the procedure and PTSD.

The trial is being conducted with the help of RTI International in Research Triangle Park, using a $2 millionDepartment of Defense grant.

But its success depends on attracting participants.

"The DOD is interested, but if we can't meet our quota, it would be for naught," Bartoszek said.

The doctor said he couldn't discuss exact numbers of current trial participants, but did say the trial is falling short of its goals.

"We're not doing as well as we'd like," he said.

Participants must meet a minimum threshold in their PTSD symptoms, and have no deployments, separations or change of stations within the two-month length of their participation.

They also must be on active duty and not have received a stellate ganglion block previously. They also can't be facing military judicial punishment.

Carol Sheff, research coordinator for the study, said the participants do not need to be Fort Bragg soldiers. They can be from any military branch, and come from any installation.

"If people can get here, they can get the treatment," Sheff said.

Officials said they hoped service members from Camp Lejeune, Seymour Johnson Air Force Base and military installations in Virginia and other surrounding states would be willing to participate.

"It's a chance for them to make a difference," Bartoszek said. "Those that are participating are doing it to help soldiers of the future. That sacrifice can occur now for the soldiers that come after them."

For more information on the trial, contact Sheff at 919- 407-1093 or csheff@sgb.rti.org, or go to sgbstudy.rti.org.

Military editor Drew Brooks can be reached at 486-3567 or brooksd@fayobserver.com.

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