The Hartford HealthCare Headache Center is currently conducting a research study of a home treatment for migraine using self-administered investigational medical device.
The study device is non-invasive and does not require medications intake. Compensation for your time and travel is available. Hartford HealthCare Headache Center medical director Dr. Brian Grosberg is the principle investigator.
Frequently Asked Questions:
Q: What is the purpose of this study?
A: The Relivion™ device used in this research is an investigational external neurostimulation device, comprised of a headset with integrated electrodes. The electrodes come into contact with your scalp, and when activated, it delivers mild electrical stimulation pulses which are intended to interfere with the migraine episode. The purpose of this research is to evaluate whether the Relivion™ device is safe and helpful in alleviating migraine pain. An earlier study demonstrated positive results.
Q: Am I eligible to participate?
A: To be eligible to participate in this study, you must suffer from migraines with or without Aura and be medically cleared by your doctor to take part in this study
Q: If am eligible and choose to participate, what will be my role in the study?
A: For this study, your study doctor will schedule a minimum of three clinic visits with you and in between those visits, 3 periods of home diary headache reports and treatment with the device, as follows:
- Screening visit: upon giving written consent to take part in this study, Your medical records will be reviewed by your study doctor and you will undergo a physical and neurological examination. You will be given a migraine diary, which you will be asked to fill in for the next 28 days up until your next study visit.
- Run-In Period: For approximately 4 weeks, you will be asked to complete a Migraine Diary, you will record migraine episodes timing, duration, intensity, use of anti-pain medications and any additional symptoms such as sensitivity to noise or light and nausea.
- Randomization visit: You will return to the clinic; the study team will review your diary to confirm you remain eligible for the study. If you are found eligible you will be trained on how to use the study device and how to report study outcomes and be released home with the device and a dedicated iPhone. You will be randomly assigned to one of 2 study groups (you cannot choose your study group; you and the study doctor will not know which group you are in):
- Group A: active treatment at a therapeutic level.
- Group B: sham/placebo treatment at a non-therapeutic level.
- Self-Practice Period: In the next 2 weeks you will be asked to experience the use of the device and diary not during a migraine episode at your home or surrounding. If at least one self-practice run was successful, you will be asked to initiate the ‘Treatment Period’.
- Treatment Period: during this period, you may use the device at your home for treating a minimum 1 and up to 5 migraine episodes, for up to 10 weeks starting from the randomization visit, whichever comes first.
- Termination visit: At the end of the Treatment Period, or after completing 5 treatments, you will return to the clinic for the last study visit. At this visit your participation in the study will be over.
You must make sure that you can come to each visit as scheduled and perform the diary reports and device treatment at home.
Q: Will I be paid for taking part in this research?
A: For taking part in this research, you may be paid up to a total of $350. You will receive the payment after you complete the study visits.