RECRUITING

External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CEFALY Pregnancy Registry

Quick Facts

Study Start:2024-11-25
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06788977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients willing and able to provide simple consent for registry participation.
  2. 2. Has access to email, text messages via smartphone or computer with internet access
  3. 3. Be between the ages of 18 to 44 years at enrollment.
  4. 4. Pregnant with one fetus/baby at time of enrollment (singleton pregnancy)
  5. 5. Have headaches or migraines prior to pregnancy and continued to have headaches or migraines into pregnancy OR headaches or migraines began while pregnant in the first trimester.
  6. 6. Able to provide proof of active intrauterine pregnancy and estimated due date, via online document upload, using any of the following documents:
  7. 1. ultrasound report of current pregnancy
  8. 2. beta hcg lab report
  9. 3. a signed provider's medical documentation confirming intrauterine pregnancy with fetal heart sounds and estimated due date
  10. 4. a signed provider's note on a prescription sheet or physician letterhead confirming intrauterine pregnancy and estimated due date
  1. 1. Patients under the age of 18 or over the age of 44 at enrollment
  2. 2. Not pregnant at time of enrollment
  3. 3. Pregnant with more than one fetus/baby at time of enrollment (multigestational pregnancy)
  4. 4. Patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study's principal investigator
  5. 5. No access to email, smartphone, or computer with internet access

Contacts and Locations

Study Contact

Michael A.L. Johnson, MD
CONTACT
203-309-3776
Clinicaltrial@cefaly.com
Gregory Panza, PhD
CONTACT
203-309-3776
Clinicaltrial@cefaly.com

Principal Investigator

Deena Kuruvilla, MD
PRINCIPAL_INVESTIGATOR

Study Locations (Sites)

https://public.smart-trial.co/#/public/649d77f0e8f8d0fb993d0c61/6626f6a04f0a3c7dd0860e14/662726d84f0a3c7dd08aeaa0/signup?lang=en-us&enforceLanguage=true
Darien, Connecticut, 06820
United States

Collaborators and Investigators

Sponsor: Cefaly Technology

  • Deena Kuruvilla, MD, PRINCIPAL_INVESTIGATOR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2030-12

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • Pregnancy
  • Migraine
  • Headache
  • Neuromodulation
  • Trigeminal Nerve Stimulation
  • External Trigeminal Nerve Stimulation
  • Postpartum
  • drug-free
  • medications
  • complementary therapy
  • alternative therapy
  • wholistic therapy
  • natural
  • non-invasive device

Additional Relevant MeSH Terms

  • Pregnancy
  • Migraine
  • Headache
  • Postpartum
  • Depression
  • Anxiety