An Indiana University School of Medicine neurosurgeon is helping change the standard of care for adults living with normal pressure hydrocephalus after performing a first-of-its-kind minimally invasive procedure to treat the neurological condition.
Normal pressure hydrocephalus is a life-threatening condition caused by a buildup of cerebrospinal fluid in the brain that has traditionally been treated with surgery that involves drilling holes in the skull.
Bradley Bohnstedt, MD, associate professor of neurological surgery, has now treated two patients as part of a pioneering clinical trial, Evaluation of the Safety and Effectiveness of the CereVasc eShunt System in Normal Pressure Hydrocephalus or STRIDE.
The IU School of Medicine is one of 26 active sites across the country participating in STRIDE, a study designed to evaluate the safety and efficacy of the eShunt System. Developed by CereVasc, Inc., the eShunt uses a catheter-based technique to place a small implant at the base of the skull by entering through a small incision in the leg. This implant helps drain the fluid into a nearby vein, relieving pressure on the brain.
“The first two implantations of the eShunt went quite well,” said Bohnstedt, primary investigator for the study at IU. “We are excited to see how our patients progress.”
More than 1 million people in the United States are living with hydrocephalus, according to the Hydrocephalus Association.
Normal pressure hydrocephalus mostly affects people over the age of 65, and common symptoms of the condition include walking and balance problems, memory decline and bladder control issues.
There are currently no pharmaceutical treatments for hydrocephalus, and the only standard of care for patients of all ages involves surgery — the most common being the placement of a ventriculoperitoneal shunt, a small silastic tube that is placed through incisions on the scalp and abdomen. The tube goes into brain ventricles where extra fluid is built up and runs under the skin to the abdomen, where it is absorbed back into the body.
While shunts have revolutionized the treatment for hydrocephalus, Bohnstedt said they can fail for a variety of reasons including equipment malfunction and infection, predisposing the patient to multiple brain surgeries.
Bohnstedt said if the eShunt system proves to be successful, more patients could avoid traditional surgery, which has higher risks and longer recovery times.
“With the STRIDE study, the location in which the excess fluid is moved from the brain is a lot shorter, going straight into blood vessels and essentially causing minimal damage to the body while better mimicking the original human state,” Bohnstedt said. “It’s a huge leap forward for hydrocephalus care, while it’s a small leap forward in terms of a change in procedure.”
Bohnstedt said the eShunt is the only endovascular shunt and the first new treatment option developed for normal pressure hydrocephalus since ventriculoperitoneal shunts were introduced more than 70 years ago.
As with any clinical trial, Bohnstedt said patients often have many questions about participating due to “the unknowns.” He encourages them to join by guaranteeing that world-class clinical care remains the standard throughout their experience.
“When we (medical experts) originally started treating normal pressure hydrocephalus, nobody really knew for sure whether draining fluid was going to help people,” Bohnstedt said. “It took years of data collection to get those answers, and that wouldn’t have been possible without patient participation.
“Our goal will always be to put the patient first and use our expertise to provide the most advanced therapies that will help improve their quality of life.”
Bohnstedt works among a larger team of researchers in the Department of Neurological Surgery dedicated to discovering better treatment options for patients of all ages with hydrocephalus.
Jason Chu, MD, MSc, pediatric neurosurgeon and associate professor of neurological surgery, is the primary investigator for the Endoscopic vs Shunt Treatment of Hydrocephalus in Infants, or ESTHI, a randomized controlled clinical trial for children less than 2 years of age with hydrocephalus. Riley Children’s Health is one of 19 sites participating in the study, which is currently enrolling patients.
Angela Richardson, MD, PhD, assistant professor of neurological surgery, was the local site primary investigator for the A Placebo-Controlled Effectiveness in INPH Shunting or PENS. Primary results of the clinical trial were published in the New England Journal of Medicine.
And Scott Mitchell, MD, a PGY 6 neurosurgery resident, is studying the development of large animal models of post-hemorrhagic hydrocephalus alongside Bonnie Blazer-Yost, PhD, director of the Hydrocephalus Research Center at IU Indianapolis.
“Brain and spine fluid dynamics is an important aspect of how our brain and spine work,” Bohnstedt said. “Our neurosurgeons at IU School of Medicine are on the forefront of expanding our understanding and advancing treatments for cerebrospinal fluid disorders.”
