Research & Clinical Trials

The following research studies and clinical trials are being conducted by the Headache Center.


Premium II Study

Principle Investigator: Dr. Abigail Chua

We are currently recruiting for this study.

You may qualify to participate in a research study conducted at Hartford HealthCare Headache Center, of a home treatment for migraine using self-administered medical device. The study device is non-invasive and does not require taking medications. Compensation for your time and travel is available.

Frequently Asked Questions:

Q: What is the purpose of this study?
A: The purpose of this study is to evaluate the safety and effectiveness of a device called gammaCore Sapphire™ for the prevention of your migraine attacks. gammaCore Sapphire™ is a handheld, non-invasive, low voltage electrical device which stimulates the vagus nerve by producing weak 120 second electrical stimulation cycles that may help reduce, ease, lessen or stop your migraine symptoms.

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: This study is divided into two periods. The total duration of your anticipated portion, the investigation, is 4 months, including 5 clinic visits and 1 phone call.

Q: Will I be paid for taking part in this research?
A: You will not be paid to participate in this clinical trial. However, you may be reimbursed for expenses associated with the cost of travelling to your study visits. You will be paid $65.00 for in person study visit (5 in total) and $25.00 for the phone call visit (Visit 3), totalling $350.00 if you complete the entire study. This may include for example, the cost of a taxi, bus or train to and from your visits, or if you travel by car, reimbursement for your mileage. You should discuss travel reimbursement with your study doctor before enrolling in the clinical trial.

To participate, please contact the study team at 860.231.0718 or HeadacheResearch@hhchealth.org.


Neurolief Study

Principle Investigator: Dr. Brian Grosberg

We are currently recruiting for this study.

You may qualify to participate in a research study conducted at Hartford HealthCare Headache Center, 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.

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 3 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 contact the study team at 860.231.0718 or HeadacheResearch@hhchealth.org.


Can DFN-15 terminate migraine with allodynia?

Principle Investigator: Dr. Brian Grosberg

We are no longer recruiting for this study.

Frequently asked Questions:

Q: What is the purpose of this study?
A: Medications that are often used to treat migraines are most effective in a short window of time after the migraine begins. The purpose of this study is to determine whether or not an investigational drug can treat a migraine after that window of time has passed. Many people who suffer from migraines experience pain on their skin (allodynia) from things that would not normally cause pain, such as light touch, when they have a migraine. We are trying to understand if the medication we give you will work to stop the migraine headache in people who have the skin sensitivity and if it reduces the skin sensitivity.

Q: Am I eligible to participate?
A: To be eligible to participate in this study, you must suffer from migraines and experience less than 16 headache days per month. You also must be medically cleared by your doctor to take this medication.

Q: What is the drug being studied?
A: This investigational drug is called DFN-15, or more commonly known as celecoxib, which is a nonsteroidal anti-inflammatory drug (NSAID). This drug is commonly used to treat pain, inflammation, and different types of arthritis, but is not currently approved for treating migraines.

Q: If am eligible and choose to participate, what will be my role in the study?
A: This study consists of two visits. The first visit will last about 30 minutes where you will have an interview about your headaches and medical history to make sure you are eligible for the study. You will have an opportunity to ask any questions that you have about the study. You will sign paperwork confirming your participation in the study and be instructed to return to the Headache Center the next time you have a migraine. The second visit will be on a separate day when you return to the Headache Center with a migraine. During this visit you will receive the study medication if you have skin sensitivity and spend about 2 hours at the clinic after receiving the treatment. It is possible that you are randomly selected to receive a placebo treatment instead of the active treatment.

Q: What is a placebo drug?
A: A placebo is a treatment that will have no active therapeutic effect in treating your condition. The placebo is designed to look and taste like the active treatment in order to prevent the participants from knowing whether a treatment is active or inactive. Placebos are often used in research because expectations about the effectiveness of the treatment can influence the results if the participants know which treatment they receive (the placebo effect).


Status Migrainosus: Differentiating Between Responders and Non-responders in the Setup of Real-life Clinical Practice

Investigators: Dr. Rami Burstein, Beth Israel Deaconess Medical Center and Dr. Brian Grosberg, Hartford HealthCare Headache Center

We are currently recruiting for this study.

Dr. Brian Grosberg, Medical Director of the Hartford HealthCare Headache Center, is co-winner of the Migraine Research Foundation's first Impact Award that will fund a 3-year study on Status Migrainosus.

To determine if you are eligible to participate in the status migrainosus study, you must first become a new patient of the Hartford HealthCare Headache Center. Click here to learn how to become a new patient.

Frequently Asked Questions

Q: What is “status migrainosus"?
A:
Status migrainosus is a severe form of migraine that lasts for 3 or more days.

Q: What is the status migrainosus study?
A:
The goal of the study is to explore how status migrainosus sufferers respond to different treatments and determine what treatments work best for different types of patients.

Q: If I am eligible and decide to participate, what will be my role in the study?
A:
There will be 4 parts to the study.

  • In part 1, you will have an interview about your headaches and complete a secure, online Headache Questionnaire if you have not done so already.
  • In part 2, you will receive a treatment that the headache specialist thinks will best treat your headaches. You will know what treatment you are receiving and will be involved in making this decision. At this visit, you will also be taught how to keep a detailed headache diary.
  • In part 3, you will complete headache diaries for 30 days. The diary for the first day will be by the hour and the rest of the diaries will be daily for the next 29 days.
  • In part 4, you will have another meeting with the headache specialist. During this meeting, you will be asked to explain your headache diaries in detail so that the headache specialist can figure out whether you have responded to treatment or not.

Q: How can my participation in this study help me and other migraine sufferers?
A:
By participating in this study, you can help take the “guess work” out of treating migraine that lasts continuously for 3 or more days. This may help to shorten and improve treatment for you and migraine sufferers worldwide.

Headache Center