Fibromyalgia & Chronic Pain LIFE Mar/Apr 2013, Issue 8 - Page 18

“ The information shared about the Phase 1 trial is very exciting. I hope that people with fibromyalgia in the Pontiac, Michigan area consider participating in the research. Without people participating in this research we will never know if this therapy could prove to be life changing for people with fibromyalgia. Learn more about this study at the “Make Fibromyalgia Visible” Conference at St. John Macomb Hospital on March 11 at 7 PM. The conference is hosted by the Fibromyalgia Association of Michigan (FAM), the Michigan affiliate of the NFMCPA. For more details visit www.mifibromyalgia.org.” (Sharon Waldrop, President FAM) quality of life. At the 2011 ACR sessions, results of a survey in a subset of the treated patients (average of 45 months posttreatment) implied that the effect is long-lived, and that the patients who responded to the sur vey reported reductions in pain drugs and physician visits. In the ACR meeting last November, Dr. Hargrove related differences in pain processing in the treated patients versus the sham patients at the end of the original study using an advanced EEG-based analysis of electrical signals in the brain called “coherence.” Just like fMRI, coherence is also able to identify network connections in the brain. Dr. Hargrove’s team used coherence to demonstrate overactive network activation, or the “turned-up volume” in people with fibromyalgia compared to those who do not have the condition. Very importantly, and as seen in Figure 1, fibromyalgia patients demonstrated reduced network activation, or in other words the volume got “turned-down”, after the RINCE treatment. This did not happen in the untreated group. ACR presentations and published papers describing all study results can be found at www.cerephex.com. D r. Deering then gave an overview of the new Phase II study expected to begin shortly at SJMO, in Pontiac, Michigan. In this study sponsored by SJMO and the Cerephex Corporation (Dr. Hargrove is the founder and Chief Scientific Officer of Cerephex, and Dr. Gendreau is the Chief Medical Officer of the Company), a total of up to 60 patients will be enrolled in four groups: One group will not receive any RINCE treatment, Other groups will receive RINCE treatments for 4, 8 or 12 weeks. weeks, or a total of 24 sessions, at the Woodward Professional Building of SJMO. There will also be a final visit about 4 weeks after the last treatment session. The routine treatment sessions will last about 20 minutes, but there are several visits where additional assessments that are part of the study will increase the average session