RELIEV-CM Clinical Study
The purpose of this research study, commonly referred to as a clinical trial or clinical study, is to develop new methods to treat chronic migraine. Research studies can contribute to a better understanding of a medical condition or the development of new treatments for patients with medical disorders.
Research study participation is completely voluntary. Even if you decide to take part in a research study, you are free to withdraw from the study for any reason.
About the RELIEV-CM Study for Chronic Migraine
The purpose of the RELIEV-CM study is to evaluate ShiraTronics Migraine Therapy System’s ability to reduce the frequency of headaches for those living with chronic migraine.
What is neuromodulation?
Neuromodulation therapy delivers small electrical pulses called ‘stimulation’ along a nerve pathway. Applying stimulation to nerve pathways in the head is intended to relieve chronic migraine symptoms.
How does it work?
Thin wires called leads connected to a small stimulator device are placed beneath the skin. The stimulator sends electrical pulses along the nerve pathways that are involved with chronic migraine symptoms. Patients are able to control their therapy using a therapy application.
Am I eligible?
You may be eligible for this study if your doctor has diagnosed you with chronic migraine and you meet the following criteria:
- Have had migraine for greater than 12 months
- Experience 15 or more headache days per month
- Have been treated with or considered treatment with onabolutinum toxin A and a monoclonal antibody against calcitonin gene-related peptide (CGRP) for migraine.
Talk to your doctor for more information.
The ShiraTronics System
What to expect
The study includes 4 phases.
1. Assessment
You will fill out a 28-day headache diary.
- Record your daily headache intensity and duration, medications, treatments, and all other symptoms.
- At the end of the Assessment Phase, your study doctor will determine if the Trial Phase is right for you.
2. Temporary Placement
You will try the therapy for about a week.
- In a simple procedure, temporary lead wires will be inserted under your skin near targeted nerves.
- You will be able to adjust the therapy with a programmer.
- At the end of the Temporary Placement Phase, the leads will be removed by your study doctor.
- Your study doctor will determine if a permanent implant is a good choice for you.
3. Permanent Implant
You will undergo a procedure to have the permanent system placed.
- The implanted stimulators and lead wires will be placed under your skin near targeted nerves in a short surgical procedure.
4. Living with a Stimulator
- The ShiraTronics System is rechargeable. You will charge the implanted stimulators each week using a charging headset and hand-held charger.
- Therapy is available and can be used 24 hours a day, 7 days a week.
- You will have regular follow-up appointments with your study doctor to monitor your progress and answer any questions.
Contact your study doctor for more information about the
RELIEV-CM Clinical Study
Note: The ShiraTronics System is not commercially released at this time.