Remote Electric Neurostimulation Device Provides Pain Relief for Adolescents With Migraine  

In a study of therapeutic remote electric neuromodulation (REN) (Nerivio; Theranica, Netanya, Israel) for the acute treatment of migraine attacks in adolescents, freedom from pain was achieved by 35% of participants. In addition, 71% had pain relief at 2 hours. Pain relief and pain freedom were sustained for 24 hours for 90% of treated attacks. Functional improvement as measured by the Pediatric Migraine Disability Questionnaire (PMDQ) was achieved by 69% of participants, giving them the ability to proceed with everyday activity at 2 hours. The PMDQ asks how migraine interferes with school and daily activities.

"Migraine in adolescents can cause significant disruptions in school attendance and social interactions," said Andrew Hershey, MD, PhD, the Endowed Chair and Director of Neurology at Cincinnati Children's Hospital Medical Center who served as lead investigator of the study. "Current pharmacologic treatments can be effective but are not always well tolerated, because of side effects. The possible addition of a drug-free treatment that is highly effective, and also safe and tolerable, will be an important option for children living with migraine." 

In the study, published in Headache, 45 adolescents, age 12 to 17 years, with episodic and chronic migraine completed at least 1 treatment with the REN device, which is worn on the arm. A total 159 migraine headaches were treated, of which most were moderate (49%) and severe (33%) at baseline. Participants mean PMDQ score was 37.1 at baseline and 18.6 at the end of the study, indicating a reduction from moderate to mild disability. No serious adverse events related to treatment occurred.

"We are extremely encouraged by the strong study results and look forward to working with the FDA towards expansion of the indications to include adolescent patients," said Alon Ironi, chief officer executive of Theranica. "Migraine can often manifest at an early age, which we all know to be a particularly vulnerable and important time in our lives. As adolescents embrace and are comfortable with new technology, we believe that our smartphone-controlled wearable may be a convenient treatment option for them."

Nerivio is a prescribed therapeutic wearable that utilizes REN to activate native conditioned pain modulation mechanism to treat pain, aura, and other migraine symproms. The device is worn on the upper arm and controlled with an App on an individual’s smartphone.