The RELIEF Study
In March of 2008, Fralex Therapeutics Inc. announced that trials on a device they developed had reached the 100th patient mark in their randomized clinical trials. The study is called RELIEF which is what the company hopes Complex Neural Pulse (CNP) therapy will provide in response to the chronic pain of fibromyalgia sufferers. The company believes that somewhere between 200 and 300 patients will need to participate in the trials for CNP in order to obtain results with statistical significance.
President and CEO of Fralex, Avi Grewal stated, “Results of the interim analysis will allow us to predict the number of subjects required to achieve statistical significance. We believe that our CNP therapy has the potential to be a safe and effective, non-drug, non-invasive treatment for pain associated with fibromyalgia.”
The Toronto-based medical technology company is studying the Model 801 PRIMA, which is a portable device about the size of a cassette tape player. For now, the device has not yet attained FDA approval for use within the United States but is undergoing Phase III trials under the Investigational Device Exemption (IDE) from the FDA. The device already has CE marketing status which means PRIMA can be sold and distributed in Europe.
Of late, researchers looking for novel ways to relieve pain have been looking into the use of magnetic pulses and mild currents applied to the external layer of the brain’s cortex so as to change the workings of the underlying cells. Scientists believe such pulses and currents may have a positive effect on brain function without the side effects of pain medication. Three such methods have been used with varying success to treat the pain of fibromyalgia. The three methods are transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS) and complex neural pulse (CNP). PRIMA is the first device that uses CNP and is distinct from TMS and tDCS in many ways:
*There is no electric current passed through the tissues, as in tDCS
*The magnetic field produced by PRIMA is low compared to that of TMS which enables the user to employ the PRIMA device from home. TMS requires a large generator, ruling out home use.
*The strength of PRIMA’s magnetic field is less than the upper industrial limits on electric hair dryers.
*PRIMA’s wave forms and pulse frequency can be tailored to specific conditions. There are unique wave forms designed for separate conditions such as pain, anxiety, and depression.
Patients in the trial wear a PRIMA headset for 40 minutes, twice daily. The headset rests somewhere above the ears so that the participants can watch TV or listen to music while receiving therapy. The device doesn’t many any noise or light, and patients feel no discernible sensation.
So far, no side effects have been seen with the PRIMA device, though the number of participants in the trials is small.