Noninvasive nerve stimulation eases functional GI pain in adolescents

Last Updated: 2017-08-29

By Anne Harding

NEW YORK (Reuters Health) - Electrical stimulation of cranial nerves via the external ear reduces pain in adolescents with abdominal pain-related functional gastrointestinal disorders, with effects lasting up to two months after treatment, new research shows.

"We found significant improvements in both usual pain and worst pain, as well as function, that were sustained, interestingly enough, even 8 to 12 weeks after the end of treatment," Dr. Adrian Miranda of the Medical College of Wisconsin told Reuters Health by telephone.

Functional abdominal pain in children and adolescents is common, and effective treatments are lacking, Dr. Miranda and his team note in their sham-controlled randomized trial, published August 18 in Lancet Gastroenterology and Hepatology.

Percutaneous electrical nerve field stimulation (PENFS) has been shown to modify visceral hypersensitivity in animals, and the U.S. Food and Drug Administration has cleared a PENFS device, Neuro-Stim (Innovative Health Solutions, Indiana), which is designed to modify central nervous system pathways by targeting branches of four cranial nerves in the external ear.

Adolescents, ages 11 to 18, with abdominal pain-related functional gastrointestinal disorders received, for four weeks, either Neuro-Stim treatment or sham treatment with no electrical charge. The primary analysis included 104 adolescents: 57 actively treated patients and 47 sham recipients.

A trained physician took 5 to 10 minutes to place each device, which participants wore for the four weeks (5 days on, 2 days off per week). Active and sham stimulations both were below sensation threshold.

The active group had a significantly greater reduction in "worst pain" than did the sham group after 3 weeks of treatment - and at a median follow-up of 9 weeks (range 8-12). Median Pain Frequency-Severity-Duration scale scores also fell more with active than with sham treatment, both at 3 weeks and after extended follow-up.

Ten patients experienced side effects: six with ear discomfort (three in each group), three with adhesive allergy (one in the device group, two with sham), and one syncope related to needle phobia (in the sham group).

The researchers recently submitted a study for publication showing that the Neuro-Stim modifies vagus nerve response in humans, "which is incredibly exciting because it opens up the possibility of other treatment options and other indications," Dr. Miranda said. "I equate it to having a UBS port in the ear. We can actually communicate with the brain."

He and his colleagues are also looking at the effect of PENFS on nausea, which occurs in about half of patients with abdominal pain-related functional gastrointestinal disorders. They plan to study the characteristics of treatment responders, to facilitate better targeting of the therapy.

The findings suggest that PENFS can reduce visceral hypersensitivity in this patient population, although further research is needed to confirm this mechanism, Dr. Miranda van Tilburg of Campbell University in Buies Creek, North Carolina, told Reuters Health by telephone. Dr. van Tilburg wrote an editorial accompanying the new study.

"There really is no evidence right now across trials that pharmacological or dietary management is helpful, and there is evidence that psychological treatments might be beneficial," she added. "The problem is that there are just not enough trained psychologists who know how to treat functional abdominal pain for this patient population."

"We really don't have good tools right now to treat these children," she added, "and it's just nice to have something new on the horizon."

SOURCES: http://bit.ly/2vpjsyO and http://bit.ly/2xuV1NL

Lancet Gastroenterol Hepatol 2017.