Researchers are narrowing in on defining the right dose of electrical current to treat chronic fibromyalgia pain via high-definition transcranial direct current stimulation (HD-tDCS)
“Despite promising preliminary results in treating fibromyalgia (FM) pain, no neuromodulation technique has been adopted in clinical practice because of limited efficacy, low response rate, or poor tolerability,” wrote lead author, Laura Castillo-Saavedra of Massachusetts General Hospital, Harvard Medical School, in a study published in the January 2016 issue of the Journal of Pain.
HD-tDCS is a form of neuromodulation that uses constant, low current delivered to specific areas of the brain through electrodes positioned on the scalp. One of the aspects of tDCS is its ability to achieve cortical changes even after the stimulation is ended.
In this Phase II, open label dose optimization study Castilo-Saavedra’s and colleagues used a visual analog scale (VAS) and measurements of the brain’s response to neurostimulation, including brain network activation pain scores of contact heat-evoked potentials, to assess pain in 14 people with fibromyalgia for a maximum of six weeks.
The primary outcome goal was to define the mean number of treatments and optimal stimulation to achieve a clinically meaningful response, defined as a 50% decrease in pain.
Half of the study participants achieved a 50% reduction in pain relief with both responders and nonresponders had significant pain reduction, and significant improvement in quality of life over time.
Castilo-Saavedra estimated that a median of 15 HD-tDCS sessions over the course of three weeks are required for a meaningful clinical outcome, and added, “The methodology for a pivotal FM neuromodulation clinical trial with individualized treatment is thus supported.”
Additional information on the clinical study can be found here. The study is not recruiting additional participants at this time.