Dr. Blumenfeld, neurologist, explains the science behind Nerivio

How Does Nerivio Work?

A 2019 study published in the clinical journal Headache showed that Nerivio lessened migraine symptoms within two hours for most participants, and completely alleviated head pain for over a third

See clinical data

66.7% of
patients

achieve pain relief at 2 hours
(Yarnitsky et al., Headache)

Non-invasive
Non-addictive
Non-pharmacological

Smart &
Personalized

From the arm to the brain

Nerivio stimulates small nerves in the upper arm. The message from the arm is received by a brainstem pain regulation center that can inhibit pain signals by releasing neurotransmitters, resulting in significant pain relief which can end the migraine attack.

Nerivio Method of operation illustration
mechanism of operation illustration mobile

Clinical Data

Nerivio was evaluated in several clinical studies to evaluate its effect in episodic and chronic migraine patients and in adolescence. The following section summarizes the studies performed by Theranica:

  • Pilot Study with episodic migraine patients
  • Pivotal Study with episodic migraine patients
  • Pilot study with chronic migraine patients
  • Main study with chronic migraine patients
  • Study with Adolescent Migraine Patients
  • Retrospective Study with Menstrual Migraine Patients

Pilot Study

The results of the pilot study were published in Neurology, March 2017:
Read Article
The pilot study was a single-center, prospective, double-blind, randomized, crossover, sham-controlled pilot study aimed to assess the safety and efficacy of non-invasive remote electrical neuromodulation (REN) with the Nerivio device for the acute treatment of migraine. In this study, 86 people with migraine with or without aura (in accordance with International Classification of Headache Disorders [ICHD] classification criteria) who had 2–8 attacks per month without preventive medications for at least 2 months were recruited. The participants were requested to treat migraine episodes at home using the device, which randomly provided one of four different stimuli programs differentiating in pulse width and one sham stimulus. Pain levels were self-reported via…

Pivotal Study

The results of the pivotal study were published in Headache, May 2019:
Read Article
The pivotal study (TCH-003) was a prospective, randomized, double-blind, sham controlled multi-center study aimed to demonstrate the safety and efficacy of the Nerivio remote electrical neuromodulation device for the acute treatment of migraine with or without aura. This study was conducted from December 2017 to October 2018 at 12 sites, 7 in the US and 5 in Israel. 296 participants with migraine with or without aura (in accordance with ICHD classification criteria) who had 2–8 attacks per month, ≤12 headache days per month, and were on either no or stable migraine preventive medications in the last two months prior to recruitment were enrolled. 252 participants were randomized…

Pilot study with chronic migraine patients

The results of the pilot study were published in Pain and Therapy, July 2020
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The pilot study (TCH-005) was prospective, open-label, single arm, dual-center study aimed to demonstrate the safety and efficacy of Nerivio remote electrical neuromodulation device for the acute treatment of migraine with or without aura in patients with chronic migraine (>15 headache days/month). This study was conducted from September 2019 to February 2020 at 2 sites (USA -1, Israel – 1). 42 participants were enrolled, and 38 participants were evaluable for analyses. A total of 210 evaluable treatments (excluding the training treatment) of qualifying migraine headaches were conducted by the 38 participants included in the analyses, with an average of 5.5±2.6 evaluable treatments per patient per 4 weeks.…

Main study with chronic migraine patients

The results of the main study will be published in Pain Reports, November 2021
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The main study (TCH-006) was prospective, open-label, single arm, multi-center study aimed to demonstrate the safety and efficacy of Nerivio remote electrical neuromodulation device for the acute treatment of migraine with or without aura in patients with chronic migraine (>15 headache days/month). This study was conducted from November 2019 to June 2020 at 9 sites in the USA. Participants entered a 4-week “Run-in” phase in which they had to report their migraine attacks and continue with their usual treatment care. Participants who reported at least 6 qualifying migraine headaches with pain data at baseline and 2 hours post-treatment were eligible to continue to the “Treatment” phase Run-in…

Study with Adolescent Migraine Patients

The results of the pivotal study were published in Headache, December 2020
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The results of the post-hoc analysis were published in Pain medicine, June 2021
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The study was a prospective, open-label, single arm, multicenter study of the Nerivio device in adolescent patients (age 12-17, inclusive), aiming to assess the performance of Nerivio in the adolescent migraine population. study was conducted from October 2019 to May 2020 (Clinicaltrials.gov number – NCT04089761). Study design and procedures Eligible participants were enrolled based on the inclusions/exclusions criteria. Following enrollment, participants entered a 4-week “Run-in” phase in which they had to report their migraine attacks and continue with their usual treatment care. Participants who reported at least 3 qualifying migraine headaches with pain data at baseline and 2 hours post-treatment were eligible to continue to the “Treatment”…

Retrospective Study with Menstrual Migraine Patients

The results of the study were published in Pain and Therapy, June 17, 2021
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The Retrospective Survey Study (TCH-009) evaluated the self-reported effectiveness and tolerability of the Nerivio device for the acute treatment of menstrual migraine, via a retrospective structured survey that was sent to adult female Nerivio users. Women aged 18–55 years who experience menstrually related or pure menstrual migraine and have completed at least four Remote Electrical Neuromodulation (REN) treatments with the Nerivio device, participated in this retrospective, observational survey study. Participants completed a short online survey assessing effectiveness, satisfaction, and safety outcomes. The survey was sent to 455 female patients aged 18–55 across the United States who used Nerivio between October 1, 2019, and October 18, 2020, and…