Experimental Device Relieves Fibromyalgia Pain in Clinical Study
Medical researchers have been testing an experimental four coil device which was designed to be used for transcranial magnetic stimulation deep within a patient’s brain. During a recent clinical study, they found some surprising instances of sustained pain relief when using the device with five fibromyalgia patients. These results show a lot of promise as a potential treatment for fibromyalgia. In fact, they have been garnering a lot of interest, and the obvious next step would be performing a larger scale controlled fibromyalgia clinical study.
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This new repetitive transcranial magnetic stimulation (rTMS) device actually builds upon an earlier model which was originally designed to help treat depression. The earlier device was built with only one coil, which was used to create a pulsating magnetic field and thus produce an electrical current within the prefrontal cortex of the patient. The newer model was designed with four coils so that it could effectively target a deeper region of the brain. This in fact is very similar to a Gamma Knife, which is used for radiosurgery. The creators of the rTMS model had a specific target in mind when they were creating this new device, the dorsal anterior cingulate. This particular region of the brain has been linked with chronic pain. The goal was to create a way to stimulate the patient’s cingulate in order to produce a noninvasive cingulotomy. Just to be clear, a noninvasive cingulotomy is a surgical procedure which can be used to sever white-matter connections within the cingulate. This procedure is only occasionally used, but it can provide pain relief for patients with severe chronic pain.
The first step in this clinical study was to use several healthy volunteers in order to test a few different four coil arrays. Doing this, medical researchers were able to effectively evaluate which orientation would produce the best effect within the dorsal anterior cingulate. They could judge the overall effect by measuring the impact of the treatment on the cingulate’s metabolism, which is determined through oxygen-15 PET scanning. Next, researchers would take the most promising orientation and test it using two different treatment models. The clinical study had 45 patients with severe chronic pain. This was a controlled study, so some of the patients were treated with a different coil orientation.
At the conclusion of the study, the researchers found the best results in five of the chronic patients. These study participants had received the highest frequency of magnetic pulses, which was about 10 Hz. The medical researchers had put these 5 patients on a specific treatment course. They would receive 10 pulses a second for 4 seconds, this was then followed by a 26 second pause and repeated. These participants received a total of 75 of these repeated courses in their daily treatment session. All in all, their daily treatment time only took about 37.5 minutes. The protocol of this clinical study required patients to undergo these sessions 5 days a week for 4 weeks in total. Three days after the last session, the medical researchers had to measure the residual pain levels off treatment using the Brief Pain Inventory (BPI). This measurement had to be repeated again after 4 weeks. In order to get the clearest results, the BPI measures were taken right at the beginning of the study, and every single day that they were administered treatment.
Incredibly, the results showed a steady drop in pain levels for all five of the patients over the course of the 4 weeks. Even better, the measurements taken after their treatments had finished showed that their pain levels had fallen even further. The lowest pain score occurred during the 4 week follow-up, at which time these 5 patients showed an average 45% drop in their recorded pain levels. So far, the treatment appears to be safe for participants. Those who received the actual treatment reported less adverse effects than those who had received phony treatment. The most common reported adverse effects of the treatment included nausea, headache, and scalp pain.