Affiliations: 1. Division of Neurology, Nuvance Health Neurosciences Institute, Poughkeepsie, NY, USA; 2. Theranica Bio-Electronics, Netanya, Israel; 3. Headache & Facial Pain, Sheba Medical Center, Ramat Gan, Israel; 4. Department of Obstetrics, Gynecology and Reproductive Biology, Danbury Hospital, Nuvance Health, Danbury, CT, USA.
Background:
Estimations are that 60% of women who suffer from migraines experience attacks that are associated with menstruation. Menstrual migraines are typically more debilitating, more painful, and of longer duration. Menstrual migraines are mainly managed by the same pharmacological treatments as non-menstrual migraine, however these treatments are less effective for menstrual migraine attacks. Remote electrical neuromodulation (REN) is a non-pharmacological abortive treatment for migraine headache. The current analysis is the first to explore REN’s effectiveness and tolerability in menstrual migraine.
Objective:
The current study evaluated the self-reported effectiveness and tolerability of REN for the acute treatment of menstrual migraine.
Design & setting:
This was a retrospective, observational survey study. Participants completed a short online survey assessing effectiveness, satisfaction, and tolerability outcomes.
Patients:
A structured questionnaire was sent to women aged 18-55 years who experience menstrually-related or pure menstrual migraine and have previously completed at least four REN treatments.
Main outcome measures:
The primary endpoints were: effectiveness of REN for menstrual migraine, and user satisfaction. Secondary endpoints included reported tolerability of the treatment, and side-effect prevalence.
Results:
Ninety-one participants qualified for the analysis, out of which 74.7% (68/91) reported that the treatment was at least moderately effective (moderately effective 37.4%, very effective 26.4%, extremely effective 11.0%). Additionally, 45.1% (41/91) reported satisfaction from remote electrical neuromodulation (slightly satisfied 33%, extremely satisfied 12.1%), while 34.1% were neutral and 20.9% (19/91) were not satisfied. Lastly, 100% of the participants reported that the treatment is at least moderately tolerable (moderately tolerable 8.8%, very tolerable 20.9%, extremely tolerable 70.3%), and 13.2% (12/91) reported mild short-term side effects.
Conclusions:
Remote electrical neuromodulation was reported as effective for menstrual migraine by most participants, and was very well tolerated. Remote electrical neuromodulation may thus provide a safe, non-pharmacological alternative for the acute treatment of menstrual migraine.
Corresponding author:
Dr. Liron Rabany, PhD, Theranica Bio-Electronics, Netanya, Israel; Adress: 4 Ha-Omanut St., Poleg Industrial Park, Netanya 4250438, Israel, Tel: +972-72-3909752, Fax: +972-72-3909762, Email: Lironr@Theranica.com.
Author emails: Hida.Nierenburg@NuvanceHealth.org, Lironr@theranica.com, tamarl@gmail.com, Roni.Sharon@sheba.health.gov.il, daganh@theranica.com, aloni@theranica.com, paul.wright@nuvancehealth.org, Linus.Chuang@nuvancehealth.org, Hida.Nierenburg@NuvanceHealth.org
Disclosure statements:
- H.N. has received honoraria from Allergan.
- H.N. and P.W. are employees of the Nuvance Health Neurosciences Institute which had received a $15,000 educational grant for neuroscience medical education from Theranica, to educate clinicians about applying neuromodulation devices to treat neurological conditions and diseases.
- L.R., T.L., D.H. and A.I. are employees of Theranica Bio-Electronics.
- R.S. has been a paid consultant of Theranica Bio-Electronics.
- L.C. reports no conflict of interests.
ClinicalTrial.GOV registration number NCT04600388
