The MC-5A, which received broad FDA 510(k) clearance in February, 2009, is a computerized medical device that applies a low amperage electric signal which transmits synthetic non-pain information through disposable surface electrodes on the skin (similar to an EKG) to surface nerve receptors of the c-fibers. Scrambler Therapy synthesizes 16 different types of nerve action potentials similar to endogenous ones, assembles them into sequences, and uses algorithms to determine patient-specific cutaneous electrostimulation to reduce and eliminate pain. ST attempts to replace the “pain” information with artificial “non-pain” information.
By providing corrective information (bioelectrical codes) through the periphery (dermatomes) to the dorsal horn of the spinal cord and central nervous system, the new code “tricks” the brain to read a discernable non-pain code as real and generated from self. When this occurs, there is an immediate “zeroing out” of the pain. Through plasticity the brain will then learn to expect, look for and prefer the non-pain code.
The MC-5A technology was developed from the research of Professor Giuseppe Marineo, a researcher and bioengineer, founder and manager of Delta Research and Development. Delta R&D is affiliated with Tor Vergata University of Rome, Italy. On February 19, 2013, The United States Patent and Trademark Office issued an International Patent for Scrambler Therapy. Scrambler Therapy is also patented in Italy. The device has CE Mark certification from the European Union.