Advanced Therapies Include Responsive Neurostimulation and Vagus Nerve Stimulation

The epilepsy team at Cincinnati Children’s is expanding its investment in neuromodulation devices as the next treatment frontier for patients with drug-refractory seizures who aren’t surgical candidates.

In 2024, pediatric neurologist and epilepsy specialist Hans Greiner, MD, co-director of the Epilepsy Surgery Program, launched a dedicated clinic for patients with neuromodulation devices.

“We’ve opened our intracranial stimulation umbrella to anyone with drug-resistant epilepsy,” Greiner says. “We now have a clinic with the sole focus of managing these patients’ devices, and we want providers to know that we offer options for many patients who didn’t have any options in the past.”

An “Iterative Process” to Controlling Seizures

In 2019, Cincinnati Children’s was one of the first pediatric hospitals in the country to use responsive neurostimulation (RNS) off-label to treat children with well-localized seizure foci. Initially, the epilepsy team used RNS to treat only patients with focal drug-refractory seizures who weren’t surgical candidates. That first year, they implanted one or two RNS devices in patients, Greiner says, and integrated those patients into existing clinics.

Since then, neurosurgeons Francesco Mangano, DO, and Jesse Skoch, MD, have developed significant experience placing RNS electrodes in multiple brain regions, including gray matter and thalamus (deep) targets.

Thalamic targets are viewed as more beneficial for stopping generalized seizures.

In 2023, Cincinnati Children’s expanded its selection criteria to include some patients with generalized seizures. That year, the team performed more than a dozen RNS procedures.

“Now we’re at 14 a year and probably will keep growing,” Greiner says, highlighting the fact that, before RNS, these patients didn’t have any other treatment options. “It’s literally creating something from nothing for a lot of our kids.”

The team introduced the weekly neuromodulation clinic to accommodate the growing number of patients they’re treating with RNS and vagus nerve stimulation (VNS) devices. The clinic was designed to provide follow-up care for patients who receive a device to manage their seizures and symptoms.

Once the device is programmed and the patient returns home, the seizure data is uploaded to the cloud so the epilepsy team can view and analyze it.

“We then plan a detection and stimulation set before they arrive at the neuromodulation clinic to try to teach the computer to recognize the seizures and to then send signals to the brain to stop the seizure in progress before the patient notices it,” Greiner says. “When we meet in the clinic, we’re enacting that plan. We’re stimulating the brain and, if the patient doesn’t have any major side effects, we’re staying with that stimulation parameter set and seeing the patient back in a couple of months.”

He adds: “It’s an iterative process patients go on with us to try to get their seizures under control.”

The Advantages of a Dedicated Neuromodulation Clinic

One of the benefits of a single clinic for this group of patients is energized learning. The new clinic brings in additional collaborators from the neurology team, including nurse practitioner Bailey Caldwell, MSN, APRN, and pediatric epileptologist Daniel Clark, MD, PhD.

Group 4, Grouped object “We can invite fellows and other faculty members to join us and help train people who otherwise wouldn’t be able to be trained,” Greiner says. “It also provides us the opportunity to do outcomes research and turn that around to clinical care. We’re building our own data, learning from that, and trying to figure out how to best help these patients.”

In fact, Greiner and his team are currently in discussions with two different device companies for clinical trials at Cincinnati Children’s that would run out of the neuromodulation clinic.

“We have experience treating these very-difficult-to-treat patients,” Greiner says. “We have patients who were having hundreds of drop seizures a day who are now having days without seizures altogether.”

Another benefit of the clinic is providing resources for patients outside of medical care. A psychologist, for example, is available within the clinic to help with mental health issues, like anxiety and depression, or navigating a career path after high school.

(Published October 2024)

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