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Four-Coil device cuts fibromyalgia pain in pilot study.


PHILADELPHIA -- An investigational, four-coil device for transcranial magnetic stimulation deep in the brain produced some striking cases of sustained pain relief when it was tested on five fibromyalgia patients in a pilot study.

Based on these promising early results, the next step will be a larger, controlled study, involving about 40 fibromyalgia patients, Dr. M. Bret Schneider said at the meeting.

The new device for repetitive transcranial magnetic stimulation (rTMS) builds on the premise of a TMS device marketed by NeuroStar and approved by the Food and Drug Administration for treating depression. Instead of the single coil used in the NeuroStar device to create a pulsating magnetic field and produce an electrical current within a patient's prefrontal cortex, Dr. Schneider and his associates designed a four-coil device to target a deeper brain region, much like a Gamma Knife used for radiosurgery. Their target was the dorsal anterior cingulate, a region of the brain linked with chronic pain The concept was to stimulate the cingulate to produce a noninvasive cingulotomy, a surgical procedure occasionally performed to sever white-matter connections to the cingulate and provide pain relief to patients with intractable, chronic pain.

Dr. Schneider cofounded a company (Cervel Neurotech) to develop this device. The first step was to test several different four-coil arrays on healthy volunteers to identify the orientation that appeared to produce the greatest effect within the dorsal anterior cingulate, based on the treatment's impact on cingulate metabolism measured with oxygen-15 PET scanning.

The developers next took the most promising orientation and applied it using two different treatment modes in a study that included a total of 45 fibromyalgia patients with chronic, intractable pain. Some patients in the study received treatments with a different coil orientation, or sham treatments.

The best results occurred in five patients who received the highest frequency of magnetic pulses, 10 Hz in the best-per-forming coil orientation. These patients had a treatment course that involved 10 pulses per second for 4 seconds, followed by a 26-second pause, and then a repeat. Each daily treatment session included 75 of these repeated courses (a total treatment time of 37.5 minutes). Patients received this daily session 5 days a week for 4 weeks, and then their residual pain levels off treatment were measured using the BPI (Brief Pain Inventory) 3 days after their last session, and then 4 weeks after their last treatment session. The researchers also performed BPI measures on each patient at baseline, and on each of the 20 days when each patient underwent treatment.

The results showed that all five patients averaged a steady drop in their pain levels over the course of the 4-week treatment, and that their pain fell even further when measured after their treatment finished. Their lowest pain level occurred at the 4-week follow-up, when they showed an overall average 45% drop in their pain scores, compared with baseline. Individually, "some of the patients had complete pain relief, while others less so," said Dr. Schneider, who is also a psychiatrist and neurosurgeon at Stanford (Calif.) University

The most common, treatment-associated adverse effects that patients reported were mild episodes of headache, nausea, and scalp pain, he said.


Major Finding: Patients with chronic fibromyalgia pain averaged a 45% pain-score cut following treatment with transscranial magnetic stimulation.

Data Source: Data came from five patients with chronic fibromyalgia pain treated with a specific transcranial magnetic stimulation coil orientation.

Disclosures: The study was funded by Cervel Neurotech, the company developing the new device. Dr. Schneider is a founder, employee, and stockholder of the company.
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Title Annotation:PAIN MEDICINE
Author:Zoler, Mitchel L.
Publication:Clinical Psychiatry News
Date:Jun 1, 2012
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