A small sham-controlled trial has shown significant differences in pain processing among fibromyalgia patients who used an FDA-approved device for at-home cranial electrical stimulation. It is evidently the first study to use fMRI to test the concept.
Fibromyalgia (FM) pain often requires extraordinary measures. To judge whether cranial electrical stimulation (CES) has any real impact on FM pain, Janet E. Taylor MD and a team at the University of Virginia have documented the effects in a randomized trial using functional MRI (fMRI), apparently for the first time.
They randomly assigned 46 participants with FM (3 men and 43 women) to one of three groups. One third were given a low-strength CES device, the Alpha-Stim, approved by the FDA for home use, with factory-inbuilt settings so that subjects could not change the level of stimulation. Another third took home a dummy device that delivered no stimulation, and the remainder continued normal care. Those issued with devices were told to use them for 60 continuous minutes each day for eight weeks, and to record their pain levels on the Numeric Rating Scale every evening.
In addition, at baseline and at the end of the study, the team examined six participants from each of the device groups using fMRI at rest and during pain stimulation. Those who had genuinely used electrical brain stimulation showed decreased or at least moderated pain activation in the insula and prefrontal cortex, as well as a significant activation decrease in areas of the brain involved in increasing or stimulating pain: the posterior cigulate gyrus, the cingulate gyrus, the thalamus, and the anterior cingulate. Differences in pain levels between the two groups were statistically significant.
Subjects using the real CES machines also reported significantly better outcomes in non-pain symptoms such as fatigue and stress.
The team plans further analysis of the data to correlate psychological factors and non-pain symptoms with neural activity in pain processing regions as well as other areas of the brain shown to be activated by pain signals.
The study is reported in Explore, The Journal of Science and Healing. The journal was launched by Elsevier in 2005 to address evidence-based research about healing from a "variety of sources, including conventional, alternative, and cross-cultural medicine."