Migraines? A Local Clinical Trial May Be for You

Print icon

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.

To participate, please call or text the study team at 860.463.2528 or HeadacheResearch@hhchealth.org.

 

 


What's New

Thyroid Nodule

What’s a Thyroid Nodule? And is It Cancerous?

Hospital of Central Connecticut endocrine surgeon Dr. Carrie Carsello, the only Hartford HealthCare surgeon who is fellowship trained in endocrine surgery, says most people diagnosed with a thyroid nodule find it a little scary. “But,” she says, “the vast majority of thyroid nodules are benign, up to 95 percent. Sometimes, though,...

New Doctors

Cancer Institute Adds Four Medical Oncologists

The Hartford HealthCare Cancer Institute announced the appointment of the following four new providers: Dr. Sara Dost, a medical oncologist and hematologist whose clinical interests are breast oncology and supportive care of cancer patients, begins in August. A graduate of the University of Western Ontario, Dr. Dost earned her medical...

U.S. News Rankings

Hartford Hospital No. 1 in Metro Area in U.S. News Rankings

Hartford Hospital has been ranked No. 1 in the Hartford metro area for the ninth year in a row and among the best in Connecticut for 2019-20 by U.S. News & World Report. The annual U.S. News Best Hospitals rankings, now in its 30th year, recognize hospitals that excel in treating the most complex patients. (To find...

Cancer

‘Breakthrough’ Summit In Bangkok: Transforming Cancer Care

By Jo Cavallo American Society of Clinical Oncology (ASCO) Dr. Peter Yu, physician-in-chief of the Hartford HealthCare Cancer Institute, is planning a new approach at the American Society of Clinical Oncology’s first international meeting, Breakthrough: A Global Summit for Oncology Innovators Oct. 11-13 in Bangkok, Thailand. Dr. Yu, past president...

Yoga for Cancer

Why We’re Testing Y4C: Yoga for Cancer Patients, Survivors

Many cancer patients seek out yoga to provide comfort, relaxation, reduce pain and anxiety. Yoga, the ancient Indian system, incorporates physical exercise and movement with mental and spiritual practice. In the United States, yoga is one of the most common forms of integrative medicine. But not all forms of yoga...

Cancer/Yoga

A Healthier You: Cancer Institute Summer Classes, Events

2019 Hartford HealthCare Cancer Institute Summer Calendar Heres your guide to all of our upcoming events for the remainder of the summer. We’d like to highlight two events for cancer survivors: Celebrate Life: A Cancer Survivorship Celebration Sept. 7 from 9:30-11:30 am Hartford Downtown Marriott The Helen & Harry Gray...