External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-44
SponsorCefaly Technology
About this trial
This online registry aims to understand the potential benefits and safety of external trigeminal nerve stimulation for the treatment of migraine in pregnant women. Women do not need to use external trigeminal nerve stimulation or any other form of migraine treatment to participate in the registry.
The main question it aims to answer is:
Is external trigeminal nerve stimulation a safe and effective option for migraine treatment during and after pregnancy?
There are no required changes in migraine treatment to participate in this registry. Participants may or may not use external trigeminal nerve stimulation or any other treatment they currently use and may still participate in the registry. There are no clinic or research visits, as the registry is entirely online. Participants will be asked to complete up to six 15- 20-minute surveys over a time period of up to 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients willing and able to provide simple consent for registry participation.
Has access to email, text messages via smartphone or computer with internet access
Be between the ages of 18 to 44 years at enrollment.
Pregnant with one fetus/baby at time of enrollment (singleton pregnancy)
Disqualifiers
Patients under the age of 18 or over the age of 44 at enrollment
Not pregnant at time of enrollment
Pregnant with more than one fetus/baby at time of enrollment (multigestational pregnancy)
Patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study's principal investigator
Trial population
All participants in the registry should be (1) age 18-44 years, (2) pregnant with one fetus/baby at the time of enrollment (3) experience migraines or headaches during pregnancy or at the time of enrollment and (4) have access to email and text messages to receive notifications and reminders for registry surveys.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
external Trigeminal Nerve Stimulation
DeviceExternal trigeminal nerve stimulation (e-TNS) is a non-invasive, nondrug option for the acute and preventative treatment of migraine. The device is marketed under the trade name CEFALY and has received clearance from the US Food and Drug Administration (FDA) for the acute and preventative treatment of migraine. The CEFALY device provides transcutaneous stimulation of the supraorbital and supratrochlear branches of the ophthalmic division of the Trigeminal nerve. Patients apply a self-adhesive electrode pad to their forehead, then place the CEFALY generator over the electrodes, resulting in a magnetic connection. The user then selects a treatment program for acute or preventative therapy, which lasts for 60 or 20 minutes.
Treatment groups
550 Participants
are divided into 2 treatment groupsGroup A: External Trigeminal Nerve Stimulation (eTNS) group1 intervention
Group B: Non-eTNS group0 interventions
Trial outcomes
Primary outcomes
1
Rate of miscarriage per trimester
Time frame
through study completion average 2 years2
Postpartum Bonding according to the Maternal-to-Infant Bonding Scale
The "Maternal-to-Infant Bonding Scale" is a scale which measures the mother's feelings regarding her child within the first few weeks after birth. The score of teh scale can range from 0 which denotes favorable or good outcome whereas the maximum score is 24 indicating a poor outcome.
Time frame
through study completion average 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov