IBS is one of the most common disorders of gut brain interaction in pediatrics. Studies have estimated the prevalence of IBS to range between 6 percent and 14 percent in children and as high as 22.0 percent and 35.5 percent in adolescents. Symptoms of abdominal pain or discomfort and change in bowel pattern can significantly impact quality of life for affected children. IB-STIM is a device-based solution that uses proprietary percutaneous electrical nerve field stimulation technology to improve symptoms and quality of life for children with IBS, without risk of complications.
"Treatment options for children with IBS are limited,” says Heidi Gamboa, DO, pediatric gastroenterologist at Nicklaus Children's Hospital. “That’s what makes Nicklaus Children’s IB-STIM program exciting — it’s a new, innovative approach with the best safety profile of all options for our pediatric patients.”
Short-Term Treatment, Long-Term Results
IB-STIM consists of a main device and four leads. The clinician places the device externally behind the patient’s ear and positions the leads on or near the ear where electrical impulses transfer to cranial nerve bundles within the ear affecting areas of the brain responsible for processing pain. As there are no incisions, the device is placed in an outpatient setting.
Unlike medication, IB-STIM comes with a predetermined start and end point. Once the device is in place, the patient goes about daily life, wearing the device for five days in a row (Monday through Friday in most cases). While in place, the device sends electrical impulses for two hours and then stops for a 35 minute period before starting again.
Following the five-day schedule, a caregiver then removes the device from the patient’s head at home. Two days later, the patient returns to Nicklaus Children’s to have the device and leads repositioned for another week of treatment.
The full therapy program lasts four to six weeks in total. Despite the short-term nature of therapy, results are often significant and long-lasting.
“IB-STIM changes kids’ lives,” Dr. Gamboa says. “When they come to us, they are missing school and are unable to eat or exercise. Within a few weeks, they are back in school and are happily eating and exercising, some with a total remission of their pain.”
Within three to six months, patients visit their pediatric gastroenterologist. In the event the effects of IB-STIM therapy wear off, patients can repeat the cycle of treatment for a longer period. Of those whose pain returns, the repeated regimens often bring additional relief, while eliminating the need to consider other therapies with potential side effects.
Growing the Candidacy
Soon after the Food and Drug Administration (FDA) approved the IB-STIM device for use in children ages 11 to 18, Nicklaus Children’s Hospital became one of the first in the country to roll out an IB-STIM program. More recently, the FDA expanded approval to cover patients ages 8 to 21, providing an initial therapy for a growing number of patients.
“The vast majority of patients we see in the office fit into a category that may qualify for treatment with IB-STIM,” Dr. Gamboa says. “In fact, every clinician within pediatric gastroenterology will see these patients on a daily basis, and this innovation gives a first-line treatment for all severities of the disease, from mild to severe.”
To promote facilities that maximize the efficacy of this therapy, NeurAxis — creator of IB-STIM — identifies programs deserving the IB-STIM Centers of Excellence title. Because chronic pain management is often a complex endeavor, earning the Centers of Excellence designation requires more than just the number of patients treated and devices placed. Instead, Centers of Excellence are facilities with protocols in place that meet the patient’s wide-ranging needs, including:
-
Mental healthcare
Since inaugurating the IB-STIM program in 2019, Nicklaus Children’s has established and followed best practices to meet pediatric IBS patients’ varying needs. As a result, Dr. Gamboa notes that Nicklaus Children’s remains the most robust IB-STIM program in the Southeast and one of only four IB-STIM Centers of Excellence in the United States.
Continued Reliance on Other Treatment Modalities
Beneficial as IB-STIM is for young patients experiencing the pains and frustrations of IBS, Dr. Gamboa points out the ongoing need for other treatment modalities. This is particularly true for those with severe symptoms and mental health comorbidities.
“Sometimes, if we treat anxiety or depression, the pain improves,” she says. “However, it can be hard to tease out whether the mental health issue is at the root of the IBS or vice versa.”
An initial consultation helps pinpoint the primary health issue. Depending on these results, Dr. Gamboa may recommend a few months of cognitive behavioral therapy, nutrition counseling or other approaches. A re-evaluation helps determine whether to continue with the prescribed treatment or take a different approach.
Even when a child is identified as a candidate for IB-STIM, based on the severity of symptoms, additional therapies may be needed to correct IBS symptoms. Multidisciplinary care helps make the most of the device therapy, as is establishing proper expectations and ensuring overall compliance by the pediatric patient and their caregivers.
“We’re rewiring pathways to produce less pain in the abdomen, but IB-STIM isn’t a magic pill that does away with disorders of gut-brain interactions,” Dr. Gamboa says. “It opens the door to kickstart other changes. There is a lot of work families must put in during and after IB-STIM therapy to have a successful outcome. Those who put in the effort to address nutrition, physical activity and mental health reap substantial reward well after treatment ends.”
To refer a patient for IB-STIM or other IBS treatment at Nicklaus Children’s, email our physician liaison.
