Trial and Success

Clinical trials are the testing ground for many innovations. Therapies, devices, procedures and drugs grow and develop under the watchful eye of research experts. Out of those studies arise new ways to approach age-old issues. Whether it’s a new visual tool for the blind, an innovative procedure for athletes or a way to improve a patient’s general life, the research in The 330’s hospitals is providing a vital thing—hope.

A NEW WAY TO SEE

A pair of glasses tricked out with a camera, electrodes and a small computer that can allow the blind to detect objects in front of them sounds like something out of a science fiction flick. However, that is the description of the BrainPort device. This piece of technology is currently being tested in a clinical trial at Akron Children’s Hospital by Dr. Richard Hertle, Director of Pediatric Ophthalmology and the Vision Center.

“This is a fascinating piece of technology,” says Hertle. “What we’re doing now is [an] opportunity to take something out of the engineer’s hands and put it in the clinic and see how it works—especially in children.”

The scientific branch of the field of sensory substitution has been around for quite a while, Hertle says. BrainPort is another piece of the puzzle that helps the blind move through the world around them. The device, created by Wicab, Inc., was originally developed for soldiers who returned from battle blinded. However, when Hertle came to Akron Children’s Hospital, he spoke with the company behind the device to begin trials on children.

The technology itself is of the problem-solving variety. Instead of using the eyes to see the world, the BrainPort device takes visual information through a different route to reach its destination. “What the technology does is bypass the eye and use the tongue to send information about the world, visual information such as motion, shape and depth, and that information is sent via a tongue electrode.” Shaped like a waffle iron with many different electrodes on it, the tongue pad stimulates the tongue, and the information moves towards the visual portion of the brain.

Hertle describes this transfer of information like a chain of conversation. The tongue starts with the information but doesn’t know what to do with it. “It says, I don’t recognize this; it’s not taste information.” Asking if anyone else wants it, the visual cortex calls out, telling the tongue to send it over. Once the information is nabbed up by the visual cortex, the brain can begin to construct the world for the patient. “That’s how, in the simplest terms, the brain takes tongue information and makes it eye information,” says Hertle.   

The study is enrolling up to 20 children, though it is not currently full. This study is funded by the Rebecca D. Considine Research Institute, an in-house Children’s Hospital supported research division of the hospital. In the long run, Hertle hopes this device will provide the blind another low-vision tool to allow them to move through the world. “They’ll be able to see people coming; they’ll be able to make those shapes out,” he says. “I think that their connection with the visual world will be enhanced.”

Unlike many research studies, this one has current, real-time results for those participating. “This is a real example of direct research scholars making a difference to an actual patient with a previously untreatable problem,” Hertle says. “This isn’t research scholars making a difference 50 years from now; this is now.”

A different view of the world

When Camryn Gattuso was born prematurely, she was only one pound, four ounces. Her lungs were not yet developed, and her retinas were damaged. As time passed, her lungs grew stronger, but she remained sightless. “She’s been blind from birth,” her step-grandmother and guardian, Sandee Gattuso says.

At 14 years old, Camryn Gattuso has participated in both the first phase of the BrainPort trial—which took place several years ago—and the current second phase. “I originally did the BrainPort when I was about 9 years old, and I didn’t fully grasp the idea of what I was doing until I did it again this year,” she says.

Gattuso describes the device as a pair of glasses with a camera on the front that can detect objects in front of the wearer. The glasses are connected to a battery pack worn on the waist, as well as a tongue pad that goes in the mouth. To increase clarity of the image, she turns a dial on the battery pack. “If I cannot see something every well, I just adjust the intensity on the tongue pad so that the image gets clearer.”

The future implications of this device are intriguing for Gattuso, who says the BrainPort allows her to view the world in a different way. “I do not see with my eyes,” she says. The trial also opens the door to hope for the 14-year-old. “I feel like a complete genius because I can see stuff when I’m using it.”

Future Developments

Dr. Hertle says that the BrainPort device is being developed by the company—Wicab, Inc.—to improve usability. Similar to a retainer worn by those with braces, this portion of the future device will be permanently in the patient’s mouth. “It can be in the mouth wirelessly all the time and then the patient can touch it when they need to instead of holding it in their mouth.”  

RECOVERY REIMAGINED

Returning to the hospital time after time can be disheartening. Wanda Staab, DNP, CHFN at Summa Health System, says she sees heart failure patients back in the hospital often. “We know that half of the patients discharged will be back in the hospital within one year. That’s our common statistic,” Staab says. “Also, about 25 percent of the patients discharged are returned within 30 days.”

With each return visit, more complications arise. One solution to a healthy recovery is limiting recurring visits. “By being able to keep them out of the hospital, [patients] will be able to live longer, healthier, happier lives,” Staab says.

Enter the SMILE trial. Testing how effectively a piece of technology—Sensible Medical’s ReDS non-invasive monitoring vest—works to keep patients from coming back to the hospital, this trial provides hope for heart failure patients. Staab is the primary investigator of the trial. “It’s a pretty exciting trial,” she says. “[This is] intended for patients who are currently admitted with a heart failure exacerbation or a flare-up of heart failure.”

Participants are given a vest to wear upon discharge. They use the vest for 90 seconds each day over a nine-month period. Military see-through technology in the device monitors the amount of fluid building up within the body—a major concern for heart failure patients. “When that fluid builds up, sometimes it happens quietly and [the patient doesn’t] realize it. That’s the beginning of a flare-up of their heart failure,” Staab says.

Fluid build-up is a major hindrance to a patient’s recovery. “With heart failure, the heart doesn’t pump fluid around efficiently. It starts to back up into the lungs, the stomach or the legs,” Staab says. The patient may experience symptoms for a while before realizing that they should go to the hospital. “In the meanwhile, their heart is not working efficiently like it should.”

Developed by a company in Israel, the ReDS vest allows the patient to remain at home and send their fluid level readings to the hospital via a cellular network. The vest has already been approved for use, and the study is now hoping to confirm its effectiveness as a way to reduce hospital readmissions.

Staab says this vest is very promising for heart failure patients. After giving someone a diagnosis of heart failure, she says they are often consumed by the meaning behind the disease. Devices like the ReDs bring hope into the picture. “Between new technologies and new medication, there’s real hope for heart failure patients.”

Mending the heart at home

James Carper is 54 years old and very familiar with heart failure. “I’ve had a total of 21 heart attacks.”

His heart attacks started in 2009, and in 2011 he had open heart surgery in Indiana. Aware of the expert cardiovascular care available in the Akron area, Carper and his wife moved here several years ago. Carper says that some of his many heart attacks were mild while others were much worse. “The back side of my heart, from what they’ve told me, is completely dead,” he says. “[There’s] no blood or oxygen.”

Carper is currently participating in the SMILE trial and uses the ReDS vest daily. “I put it on every morning, and it takes a reading to see how much fluid builds up in my lungs because I’m dealing with congestive heart failure.” This is perfect for Carper, who says this technology helps to keep him going every day—something vital for his family.  Carper’s wife is disabled, and he says he needs to be home to help her as well as work on their home. “Having the vest keeps me home, recovering. It’s a lot quicker for many of the problems that I have than being in the hospital [for] two weeks at a time.”

FINDING HOPE FOR THE FUTURE

Every October, NFL players don pink uniforms to help bring awareness to a specific type of cancer. Unfortunately another form of cancer—prostate cancer—does not receive the same kind of attention.

There is currently no cure for the disease. The latest clinical research trial underway at Cleveland Clinic Akron General is looking at how a combination of drugs might offer the smallest glimmer of hope to patients who have exhausted every treatment available.

“This is a protocol for very late-stage cancer, people who’ve had everything so far,” says Dr. Esther Rehmus, who has been practicing in hematology and oncology at Cleveland Clinic Akron General since 1988. She sits on the hospital’s Investigational Research and Review Board (IRRB) and is the chair of their cancer protocol review committee. “Basically, there’s out-patient research done in the cancer division, and that’s what I keep an eye on,” she says.

If prostate cancer is detected early, it is often quite treatable with a high prognosis for a full recovery. However, once the disease reaches an advanced state and spreads to other parts of the body, there are few treatment options. Rehmus is working with colleagues at Johns Hopkins Hospital in Baltimore on this Phase II trial funded by the Akron-area One-In-Six Foundation to expand those options.

Prostate cancer will often respond to certain drugs in the short-term, then become resistant to them for a variety of reasons. This trial is studying whether a specific drug therapy can re-activate a response in the disease.

“If a patient has already had a drug called enzalutamide and then had progression of cancer,” Rehmus says, “we are trying to re-sensitize them by adding dexamethasone, which is a kind of steroid.” Hormonal steroids like dexamethasone have long been an established treatment for reducing the symptoms of cancer, like pain, fatigue and anorexia.

While a cure will not likely arise from this study, the hope is to improve both quality and length of life for the participants while the race for a cure continues.

A positive legacy

Age 50 can be a pivotal time for many men. It’s often when men begin to think about retiring, traveling, or remodeling their empty nest. Sometimes, though, life has other plans in store.

One month after his 50th birthday, J. Bruce Hunsicker was diagnosed with inoperable metastatic prostate cancer. The vibrant, successful attorney, husband and father of two sons was completely stunned. “Prostate cancer was just not on our radar,” says Laura Hunsicker, Bruce’s widow and the president of the One-In-Six Foundation.

Bruce and Laura Hunsicker started One-In-Six shortly after Bruce’s diagnosis in 2005. “At the time, one in six men were diagnosed with prostate cancer,” says Laura Hunsicker. “It’s now currently one in seven men, [which] is great.”

The all-volunteer foundation raises money through donations, grants and events, then uses 100 percent of the proceeds to raise awareness of the disease, fund research into treatment and a cure, and provide free PSA—prostate-specific antigen—testing to men in the Akron area.

Bruce lost his battle with prostate cancer in 2010, but his positive legacy continues in the research One-In-Six supports. “Working in conjunction with Akron General, having this joint clinical trial, has been a wonderful thing,” Laura says. “I’m very proud of it, and I think Bruce would be so happy that we’re doing something local.”

REPAIRING TEARS WITH BIOLOGICS

Tearing the anterior cruciate ligament, or ACL, is one of the most common knee injuries around. Dr. Paul Fleissner has been performing ACL repairs on young athletes at the Crystal Clinic Orthopaedic Center in Akron for 26 years. While most of his patients recover well and return to playing sports in about a year, Fleissner noticed many of them suffering a second tear, looseness in the joint, or early-onset arthritis after the procedure. During a second surgery on these patients, Fleissner found poor blood-flow and tissue regrowth to be the culprits.

“It fascinated and frustrated me at the same time,” he says. He set about trying to figure out how to improve these results. During his research, he found interesting work being done with biologics—products like blood, vaccines or gene therapy that are synthesized from organic components.

“I stumbled on platelet-rich plasma (PRP) first,” he says. “It had a good initial effect on the patient, but it didn’t seem to last.” PRP injected during an ACL surgery is gradually broken down by the natural enzymes in the joint. Further research into a way to prolong the effects of PRP led Fleissner to a solution. “I found some animal studies that were using PRP with a collagen carrier,” he says. “Collagen is resistant to some of the enzymes in the knee that cause breakdown and acts as a protective mechanism for the PRP.”

Fleissner and the clinic obtained approval to use this combination in human ACL surgeries, and the FastFlex™ technique was born. “We developed a way to combine the two for reconstructions, and it produced a fantastic result,” he says. Those results include recovery time of about six months instead of a year, and about half the rate of failures that require a second surgery.

FastFlex™ has potential for a much wider range of patients than just athletes. “People are using PRP and stem cells in older patients to slow or reverse the arthritis process, and to prevent total knee replacement or make it at a much later age,” Fleissner says.

While the protective factors of collagen and PRP seem clear, the reparative effects are still not certain. Nevertheless, Fleissner and his team continue to learn from and improve on their ground-breaking procedure. “I hope we’ll continue to make this the standard of care for the future.”

Back in the game

In November of 2014, Jacob Bush was an active, athletic kid in eighth grade. At the tender age of 14, he’d already had several injuries and surgeries, including a torn meniscus and a total ACL reconstruction.

During an afternoon football practice, Bush suffered an injury to his previously unharmed knee. “I was going out for a pass and went to toss the ball,” he says. “I felt a sharp pain in my knee and fell to the ground.”

Dr. Fleissner—who already knew Bush from his previous surgeries—examined the knee and found the ACL was torn.

When Fleissner presented the idea of his FastFlex™ procedure to the Bushes, Jacob’s mother was wary. “I was not excited about the thought of my son going under the knife again,” she says. “But we wanted to do everything we could [for] Jacob.”

Six months of grueling physical therapy followed the successful procedure, but Jacob Bush was motivated to get through it by the promise of returning to lacrosse in the spring. “It was really hard, but I liked it because I knew I was getting better [and] could feel myself getting stronger,” he says.

Bush can now run and kneel with no pain. He also has new career aspirations that his mother says were never mentioned before his experience with Fleissner and his team. “I want to go into sports medicine,” Bush says. “I’m interested in the body and the ligaments.”