The RIME study
Diseases of the Nervous System
What is the purpose of this trial?
The Relivion device is an external, non-invasive neurostimulation investigative device that does not require medication intake, comprised of a headset with integrated electrodes. If you agree to take part in this research, your medical records will be reviewed by your study doctor and you will undergo a physical and neurological examination and your vital signs will be measured (heart rate, blood pressure and respiration rate). Following these initial assessments, you will start the 'Run-In Period'. During this time, for approximately 4 weeks, you will be asked to complete a Migraine Diary. You will return to the clinic after these 4 weeks and the study team will review your diary to confirm you remain eligible for the study. If you are found eligible you will be randomly assigned to one of 2 study groups (you cannot choose your study group, you and the 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.
At this stage you will be trained on how to use the study device and how to report study outcomes. 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. If at least one self-practice run was successful, you will be asked to initiate the 'Treatment Period'. During the Treatment Period, you may use the device at your home or surrounding for treating a minimum 1 and up to 5 migraine episodes, for up to 10 weeks starting from the randomization visit, whichever comes first. You will be asked to return the device and smartphone.
For information please contact:
Phone: +1 203-785-5719
- Ages18 years and older
- Trial withNeurolief Ltd.
- Start Date01/16/2019
- End Date12/30/2018
- Last Updated05/07/2019
- Study HIC#2000024195