VAGUS NERVE STIMULATION
The vagus nerve is the longest cranial nerve. It runs from the brain to key organs in the body. The vagus nerve helps manage the immune system, which defends the body from infections and controls inflammation.
Vagus nerve stimulation uses an implanted device to apply a small amount of electricity to the vagus nerve which may decrease the kind of inflammation that is present in people with Rheumatoid Arthritis (RA).
The MicroRegulator is an investigational medical device about the size of a daily multi-vitamin capsule designed to provide electrical stimulation to the vagus nerve specifically to treat RA.
The device does not administer any drug into the body, but rather, the MicroRegulator applies a small amount of electricity to the vagus nerve for about 1 minute per day. This electricity activates the body’s mechanism to reduce inflammation. Physicians use an iPad to program each patient’s MicroRegulator to turn on and deliver the therapy automatically every day so that patients do not need to remember to turn on the device.
At the end of the 12-week study period, you will have the option to leave the device on, turn the device off but leave it in place or completely remove the device.
Over the past 20 years, more than 100,000 patients in the US have undergone vagus nerve stimulation for treatment of epilepsy or depression. The device used in the RESET-RA research study is the first vagus nerve stimulation device designed specifically to treat RA.
The investigational device for the RESET-RA study is placed on the left vagus nerve through a small incision in the crease of the neck. The 60-90 minute implantation procedure is performed by an experienced surgeon while the patient is under general anesthesia. The patient typically returns home a few hours after the procedure and the healing process takes about 14-21 days.
The safety profile of the investigational vagus nerve stimulation device is currently unknown. Your physician will review the Informed Consent Form with you, which lists the possible risks and benefits associated with the device and clinical study.CLICK HERE to learn more about the RESET-RA study