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Abstract Details

Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Adolescents
Headache
Headache Posters (7:00 AM-5:00 PM)
028

Current acute treatments for migraine in adolescents may have limited effectiveness, can cause side effects, and may lead to medication overuse. REN is a novel acute treatment of migraine which stimulates upper arm peripheral nerves to induce conditioned pain modulation (CPM) - an endogenous analgesic mechanism. The REN device (Nerivio®, Theranica Bio-Electronics LTD., Israel) is FDA-cleared for acute treatment of migraine in adults.

The current study assessed the efficacy and safety of remote electrical neuromodulation (REN) in adolescents with migraine.

This was an open-label, single-arm, multi-center study in adolescents (ages 12-17 years) with migraine. Participants underwent a 4-week run-in phase during which the headaches were recorded in an electronic migraine diary. Eligible participants continued to an 8-week treatment phase in which they were asked to treat their headaches with the device. Pain severity levels, associated symptoms and functional disability were recorded at treatment initiation, 2- and 24-hours post-treatment.

Sixty participants were enrolled of which 39 participants completed a test treatment with REN. Pain relief and pain freedom at 2 hours were achieved by 71% (28/39) and 35% (14/39) participants, respectively. Nausea, photophobia, and phonophobia disappeared at 2 hours in 54% (12/22), 42% (13/31), and 40% (10/25) participants, respectively. 69% (23/33) participants experienced improvement in functional ability at 2 hours. Consistency analyses across multiple attacks showed that 66% and 33% of the participants experienced pain relief and pain-free responses, respectively, in at least half of their treated attacks. Safety analyses were performed on 45 participants who used the device at least once. One device-related adverse event (2%) was reported in which a temporary feeling of pain in the arm was felt.

REN provides clinically meaningful relief of migraine pain and associated symptoms, offering a safe and effective non-pharmacological alternative for acute treatment in adolescents.

Authors/Disclosures
Andrew D. Hershey, MD, PhD, FAHS, FAAN (Cincinnati Childrens Hospital Medical Center)
PRESENTER
The institution of Dr. Hershey has received personal compensation in the range of $0-$499 for serving as a Consultant for Amgen. The institution of Dr. Hershey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. The institution of Dr. Hershey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. The institution of Dr. Hershey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Upsher-Smith. The institution of Dr. Hershey has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. The institution of Dr. Hershey has received research support from Amgen. The institution of Dr. Hershey has received research support from NIH, NINDS. The institution of Dr. Hershey has received research support from Bioahaven. The institution of Dr. Hershey has received research support from Upsher-Smith. Dr. Hershey has received publishing royalties from a publication relating to health care.
Tamar Lin (Theranica Bio-Electronics) Tamar Lin has received personal compensation for serving as an employee of Theranica Bio-Electronics.
Yaron Gruper (Theranica) Yaron Gruper has nothing to disclose.
Frank R. Berenson, MD Dr. Berenson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Upsher smith. Dr. Berenson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Berenson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Berenson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Berenson has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biohaven. Dr. Berenson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergan. Dr. Berenson has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Atlanta Headache Specialists .