Advancing brain health: Baptist Health is first in Florida to participate in innovative clinical trial

Baptist Health’s commitment to advancing community health through innovative medical research is underscored by its participation in a new clinical study to evaluate the safety and effectiveness of a novel, minimally invasive investigational system to treat patients with normal pressure hydrocephalus. The health system is the first in Florida, and second in the nation, to enroll patients in this cutting-edge research that could lead to less invasive procedures and improved outcomes for patients.

Normal pressure hydrocephalus, or NPH, is a buildup of cerebrospinal fluid in the brain. This excess fluid causes pressure on the brain, which can lead to neurological issues such as cognitive impairment (like dementia or memory loss), difficulty walking (gait disturbance) and issues with bladder control (incontinence). Only 20% of the estimated 800,000 adults in the U.S. with NPH are appropriately diagnosed due to the symptomatic similarities with other diseases such as Alzheimer’s or Parkinson’s. Since NPH primarily affects individuals aged 60 and older, these symptoms are also often wrongly attributed to normal signs of aging.

Over the last 70 years, the primary surgical treatment for NPH has been the ventriculo-peritoneal (VP) shunt. This procedure requires open brain surgery in which a tube is inserted to drain excess fluid from the brain to the abdomen.

The STRIDE study compares the safety and effectiveness of the traditional VP shunt with the investigational eShunt® System. This new, minimally invasive endovascular method involves inserting a much smaller shunt using a catheter from a vein in the patient’s leg via a small incision. The eShunt Implant drains cerebrospinal spinal fluid into the patient’s venous system, allowing fluid in the brain to be absorbed by the body in a way that mimics the body’s natural physiological process. The new system allows for a minimally invasive treatment option, which could lead to quicker recovery times. Patients typically spend just one night in the hospital, with the potential for lower rates of infection and over drainage, alleviating common problems seen with the traditional VP shunt.

Patients participating in the randomized trial will either be selected to receive the traditional VP shunt or the new shunt.

To participate in the trial, patients must meet the following criteria:

• Aged 60 or older
• Have had problems walking and take shuffling steps (small steps or slide their feet instead of lifting them) for three or more months
• Have at least two of the most common symptoms of NPH

“Normal pressure hydrocephalus is often difficult to diagnose, but having access to timely detection and prompt treatment can significantly enhance a patient’s quality of life. NPH is a reversible cause of dementia, and we are very excited to see improved opportunities for this patient population,” said Ricardo Hanel, MD, PhD, neurosurgeon and co-medical director of Baptist Stroke & Cerebrovascular Center, which is the only Joint Commission Certified Comprehensive Stroke Center in the greater Jacksonville region. “By participating in this clinical study and others, we are exploring new treatment possibilities that have the power to transform the lives of our community and beyond.”

The study is designed to support the device manufacturer’s anticipated premarket approval submission to the FDA of the new shunt.