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Pure hope 

At the 10-year anniversary of 9/11, Fort Carson works on a study with promise for treating traumatic brain injuries

When the bomb exploded under her Humvee in Iraq five years ago, Margaux Vair recalls, it slammed her head against the gun turret.

"I remember my ears pounding and my head hurting," says Vair, a Lakewood native now living in Kent, Ohio. "I got a severe concussion, but I didn't know how bad it was at the time, like how bad my nerve damage was."

Bell's palsy froze part of her face, she couldn't remember things, her head pounded, and she couldn't sleep. After being assigned to Fort Carson's Warrior Transition Unit, she was medically discharged from the Army in 2008.

Then she heard about a treatment that relies on one of the world's most common elements. After 80 exposures to 100 percent oxygen in a high-pressure hyperbaric oxygen chamber in Boulder, Vair says she's finding her way back.

"I had never felt that good since the injury," she says of the treatment. So good, in fact, that she's stopped taking painkillers and sleeping pills that the Army prescribed. "I am happier. I feel a thousand times better."

Vair is lucky. A generous friend and private donors ponied up the thousands of dollars in treatment costs, because her country wouldn't.

One study estimates 320,000 soldiers deployed to the wars in Afghanistan and Iraq are afflicted with traumatic brain injury (TBI), labeled the signature injury of the war on terror. In Iraq and Afghanistan, blasts from mortars, rockets and improvised explosive devices have left thousands of soldiers with symptoms that could include headaches, balance disorders, insomnia, judgment deficiency, anxiety, depression and much more.

Some have turned to hyperbaric oxygen therapy (HBOT). Like Vair, they say it works. And data supports the idea that HBOT can heal the brain, or at least relieve problems caused by damaged brain tissue. But the government won't pay, because it doesn't recognize HBOT as a legitimate treatment for brain injury. It's never been proven effective with undisputed scientific research.

Now, just such a groundbreaking study is underway. At Fort Carson, Fort Gordon in Augusta, Ga., Camp Lejeune in North Carolina, and Camp Pendleton in Southern California, 96 soldiers will either help establish HBOT as an effective avenue for healing TBI or dismiss it as voodoo science.

Because the study follows rules that are considered the gold standard of scientific research, such as using a placebo group, its findings could lead to taxpayer funding for military members' HBOT treatments and, eventually, reimbursement by Medicare, Medicaid and private insurance for civilians. The first hyperbaric oxygen exposure in Carson's part of the study was conducted Aug. 4.

"We don't know if it works and if it does work, how it might work. That's the million-dollar question," says Lt. Col. Robert Price, the principal investigator of Fort Carson's study. "That's why we're doing extensive research to see how it might change the injured brain to make it better. I'm cautiously optimistic that this study will answer the question of whether it's effective or not."

'Poorly understood'

Steve Reimers, of the International Hyperbaric Medical Association, has been working with HBOT for 42 years. He says for a long time, the pervasive public belief has been that "there's nothing you can do for a brain injury but go home and get used to your new life."

In light of the numbers, that's a more chilling idea than ever before. Nearly one in five of the 1.6 million who've served in Afghanistan or Iraq since October 2001 suffer with TBI, according to a 2008 Rand Corp. study, titled "Invisible Wounds: Mental Health and Cognitive Care Needs of America's Returning Veterans."

Commonly caused by vehicle accidents, bad falls and violence, TBI is the most prevalent of mental health or cognitive conditions affecting returning soldiers. Taking into account treatment, losses in productivity and societal tolls such as suicides, impaired relationships and homelessness, it costs roughly $30,000 per case, per year, Rand reports. If that price tag is applied to 320,000 soldiers, the cost would approach $10 billion annually.

But Rand can't be sure its numbers are accurate, because its estimates are based on a stunningly low number of actual diagnosed cases — 2,776 through mid-2007 — that it used in its 2008 study. The fact is, Rand reports, TBI is "still poorly understood, leaving a large gap in understanding how extensive the problem is or how to address it."

Iraq and Afghanistan Veterans of America's website says while the Department of Defense (DOD) has expanded research, "inadequate screening and shortages of mental health professionals in the military are still keeping troops from getting the care they need."

One problem is that the military uses what the IAVA calls "an ineffective system of paperwork" to conduct mental health evaluations, requiring a brain-injury diagnosis be based on documentation of when and where the injury occurred. That means soldiers have to scrape together duty orders and other forms, including statements from fellow soldiers, sometimes months or years after they figure out they've been affected. In addition, TBI can carry the same symptoms as post-traumatic stress disorder (see "What's the difference?" p. 21), further complicating the diagnosis.

Assuming someone can be diagnosed, what kind of treatment is available?

IAVA says the Department of Veterans Affairs has improved its response to brain-injured soldiers, but others are more critical. Soldiers often are merely given prescription drugs to treat their symptoms, says Robert Alvarez of Colorado Springs, a soldier advocate and psychotherapist who's worked with many soldiers with brain injuries. He says some take eight to 10 prescriptions at a time, some costing $1,000 a month. HBOT is a better alternative, he says, by a long shot.

"I know it works. I've seen it with my own eyes," says Alvarez, who helped pay for Vair's therapy from his own pocket. "I've seen soldiers who were bedridden and had no life get up and have a life. The results are nothing less than spectacular."

'Not a fluke'

Hyperbaric oxygen therapy was developed in the early 1900s to treat divers for decompression sickness. Several decades later, researchers found it to be effective for other conditions.

Normal air contains about 21 percent oxygen. During HBOT treatment, a patient either sits or lies in a cylindrical chamber and breathes in 100 percent oxygen under high pressure, delivering up to 15 times the oxygen content to body fluids. According to the Mayo Clinic, when increased oxygen dissolves in your blood, it "stimulates your body to release substances called growth factors and stem cells, which promote healing."

The government and insurance companies reimburse HBOT for 13 indications, including gas gangrene, obstructions of blood supply, wound healing, severe anemia and "flesh eating bacteria." But it's expensive medicine.

Ryan Fullmer, program director at Rocky Mountain Hyperbaric Institute, says a new single-person chamber can cost $200,000; multi-person chambers generally get more expensive from there. Apparatuses with multiple chambers, he says, can cost millions. As for the sessions themselves, they run from $100 to $250 per treatment in clinics, to $30,000 for 40 treatments in hospitals. HBOT used for traumatic brain injury usually spans 40 to 80 one-hour treatments spaced over weeks or months.

Congress has considered bills to cover the treatments, but nothing has become law. U.S. Rep. Doug Lamborn, whose district includes Fort Carson, hasn't taken a stand.

In a statement given in response to an Indy request, the Republican says that caring for injured combat veterans is a high priority and that he's "hopeful" HBOT will prove successful. But, he adds, "Many medical challenges remain before HBOT can be used as a standard treatment for TBI."

Dr. Paul Harch, an associate of Reimers with the International Hyperbaric Medical Association, is used to the skepticism. He testified in July 2010 before the House Veterans Affairs Committee, saying he's collected preliminary data showing that 15 veterans exposed multiple times to 100 percent oxygen under high pressure saw a 15-point increase in IQ scores, a 40 percent reduction in post-concussion symptoms, a 30 percent reduction in PTSD symptoms, and a 51 percent decrease in depression. Those results came from an ongoing observational study by doctors monitoring response to HBOT on up to 1,000 patients with TBI, post-concussion syndrome and PTSD at up to 24 sites in the United States, including the Rocky Mountain Hyperbaric Institute.

Harch assured the committee his science "is not a fluke or statistical aberration," and emphasized that absent an alternative like HBOT, soldiers and veterans are being given psychoactive drugs "strongly associated with increased suicide rates."

In an interview, Harch says data collected since his testimony reinforces his earlier findings. But policy-makers may find it hard to swallow because of the financial implications.

"You do the math," he says. "In a down economy, at a time of Pentagon budget cuts, who's going to pay for it?"

Reimers says even more overwhelming are the implications of HBOT's cost to the government and insurers for the civilian population, 5 million of whom suffer from lingering TBI disability, according to the Centers for Disease Control.

Regardless, Harch's observational study isn't what the military is looking for, because it doesn't include a placebo group and other protocols, such as the concealment of data from doctors until the study is completed.

"It's going to take a published study [that] the powers that be will be willing to stand behind — a study they're doing," Harch says.

The Pentagon actually has three underway, all using the required protocols. The one involving Fort Carson is sponsored by the U.S. Army Medical Research and Materiel Command.

Twenty-one tests

Carson's Lt. Col. Price graduated from the University of Colorado-Denver's School of Medicine in 1998, after going through college in the ROTC program. Soon thereafter, the Wyoming native was learning the ABCs of "dirt medicine."

Price was "involved intimately" in one of the largest engagements by conventional U.S. troops in Afghanistan. The battle against al-Qaida forces, in a remote valley in March 2002, is documented in Army Times reporter Sean Naylor's bestseller, Not a Good Day to Die: The Untold Story of Operation Anaconda. Price appears in the book.

"We recognized early on that, yes, [TBI] was a new problem," Price says today. "The magnitude has certainly increased over time."

Price has now been deployed six times to either Afghanistan or Iraq. At one point, he advocated placing HBO chambers in the theaters of operation.

"I had seen the miracle of HBO for dive injuries," says the doctor, who worked with divers in the military. "It's not unusual to have a guy get out of the water and be paralyzed on half of his body. And in five minutes they're restored. I saw the power of it there, and I said, 'Hey, what if this might help?' Especially on the battlefield, as I watched people die while they were getting cared for.

"[But] logistically, it was difficult and challenging to try to get that done in the chaos of the battlefield, in the fog of war."

In 2009, top officials and medical personnel in Washington, D.C., OK'd the study that would allow Price and others to conduct research on American soil. Price says Carson might wind up with more soldiers than other sites, because the research team has reached out directly to soldiers with TBI, rather than relying on fliers to attract study candidates. To be chosen, soldiers have to be active-duty and must have hit their heads or developed PTSD in combat sometime after 9/11.

Once selected, they're examined using 21 neuropsychiatric and neurophysiologic assessment tests to measure cognitive thinking, how they react, how volatile they are, how they problem-solve, language abilities, eye movements, balance and coordination. CT scans and MRIs assess metabolic function and brain blood flow.

Then the soldiers are given 40 exposures of 100 percent oxygen at high pressure over eight weeks, followed by a repeat of the assessment tests. Four to six months later, the tests will be given again, "to see if there was any ... lasting, durable change," Price says.

"We all learn in medical school that nerve cells do not regenerate," Price says. "Some evidence that's been suggested is contrary to that." Such as Harch's work at Louisiana State University, where scans before and immediately after HBOT show increased activity.

Price says his testing and exposures take place during duty hours, and commanders must give permission. So far, commanders have been supportive, he adds. As of Aug. 29, 28 soldiers had been chosen, and as of Aug. 22, six had been inside the chamber.

Half the subjects won't get the real deal. A technician who runs Carson's chamber, which holds up to 18 people at a time, draws a curtain over the control panel during exposures so that neither doctors nor researchers can see whether 100 percent oxygen or ambient air is being delivered. That measure assures the study will be totally data-driven, according to Price.

A third group will receive no oxygen treatment, but rather the current TBI care including drugs, creating yet another control group.

Should the study prove HBOT makes a difference, those in the placebo group and the control group will get full oxygen treatment, says Roger Meyer, Army Medical Department Activity public affairs officer.

Researchers hope to have all data collected and analyzed by next summer. The number-crunching will be handled by EmpiriStat, a Maryland-based contract research organization that could interrupt the study if early results show HBOT is a phenomenal success or a danger to soldiers, Price says.

Price isn't sure the Carson study will change payment for HBOT unless findings are "dramatic." But he knows many are watching.

"I've had lots of e-mails and inquiries. Soldiers, their families, physicians, politicians, high-ranking officers. We're all looking for hope, and this modality of treatment suggests that there might be some hope."

Trying to heal

Hope is what Johnny Carabajal is clinging to. Here's how he tells his story.

As a medic with a parachute infantry regiment in Alaska, he was deployed in 2006 and 2007 to Iraq, where he suffered three head injuries. The first came as he cared for buddies after an IED blast. As he pulled four guys from the vehicle, a rocket ignited, blowing him back. "I was totally disoriented," he says. "But there were far worse injuries, so my primary concern was everybody else." He says he had vertigo for a week.

A couple months later, mortars showered on his patrol base, one hitting near him, blowing him face-first into the sand. Afterward, he had vertigo for three weeks and felt clumsy. A month later, a crash in his convoy slammed his head into a window.

After his 2007 discharge, he realized his memory was shot. He had to write down simple tasks as reminders. His headaches were so severe he couldn't hold a job, because he couldn't stand to be in the light.

He dismissed his symptoms at first. "I had friends who were dead, who had amputations, burns all over their bodies," he says. "'OK, I need help with my nightmares.' It seemed real petty."

Moving to Colorado Springs to be with family members, Carabajal hooked up with the Wounded Warrior Project, which pointed him to the Rocky Mountain Hyperbaric Institute. Now living in Broomfield, Carabajal has gone through 36 of 40 treatments over a span of five weeks as of mid-August, all donated.

Though Carabajal thinks he'll need 40 more treatments after the first regimen, he says his headaches already are less frequent and severe.

"I definitely feel like the clutter that's in my head, all my thoughts combined that are overwhelming, are becoming a little bit easier to piece out individually," he says. "I'm becoming more productive, and I'm even wanting to pursue going to college to do some business courses, so I can own my own business."

zubeck@csindy.com


What's the difference?

— Pam Zubeck

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