The EDGE Medica Project News
The Neuronetics Transcranial Magnetic Stimulation System
EDGE Medica was a part of the team Neuronetics assembled to take their Transcranial Magnetic Stimulation System (TMS) from benchtop laboratory/clinical trial units to systems ready for sale to clinicians. EDGE Medica designed and fabricated a “looks-like” demonstration model that had many of the user and patient interfaces functioning in a “works-like” manner. In close collaboration with Neuronetics and other team members, EDGE Medica’s industrial designers refined the styling, ergonomics, and graphical user interface, giving the model the high-tech look, feel, and functionality demanded by clinician focus groups. In addition, EDGE Medica’s engineers wrote many of the technical design definition documents required by Neuronetics’ ISO product development procedures. Finally, EDGE Medica designed, procured and fabricated all parts required for fully working models of the next generation system. This included key elements such as the system disposable, which incorporated new sensor technology and active electronic security functionality employing approaches capable of meeting critical cost targets.
The following is an excerpt form the May 2, 2005 press release by Neuronetics:
Press Release: Transcranial Magnetic Stimulation System
New Investigational Procedure to treat major depression being tested in global university medical and clinical research centers. Twenty sites conduct clinical research trials on investigational, non-medication approach to treat depression.
MALVERN, PA, May 2, 2005 -
Transcranial Magnetic Stimulation (TMS), an investigational, non-medication approach that uses repeated short bursts of magnetic energy to stimulate nerve cells in the brain has been studied in numerous small clinical research trials. The results from these trials have encouraged researchers that TMS may produce an antidepressant effect. TMS is now being tested a t 20 university medical centers and clinical research centers as a potential future treatment for patients with major depression.
“The ongoing clinical trial will include approximately 300 individuals at 20 centers,” said Bruce Shook, president of Neuronetics, Inc., the company that developed the TMS device. “more than half of the required study participants have now been enrolled. The study is moving along rapidly and will be completed this year.” Typical ways of treating depression include antidepressants and other medications; electroconvulsive therapy (ECT); and psychotherapy. This study focuses on people who either have failed to benefit from antidepressant medications or have been unable to tolerate the adverse effects of antidepressant medications.
Regulatory Clearance Sought
The clinical trial currently underway is a large, rigorous, controlled trial designed to provide data in support of a regulatory application to the U.S. Food and Drug Administration for marketing clearance of the Neuronetics TMS System for the treatment of depression.
“If it is proven effective, TMS would be an innovative and non-invasive therapeutic option, especially for people who haven’t benefited from other therapies,” said Shook. “We anticipate seeking FDA approval in 2006.
Noninvasive Technique
Researchers believe the left prefrontal cortex is one of the critical components of the brain circuitry involved in regulating mood. Transcranial Magnetic Stimulation (TMS) produces pulses of magnetic energy that are directly targeted at this part of the brain with the goal of improving the function of these key brain pathways. The TMS technology creates a high intensity magnetic field with characteristics similar to those produced by standard MRI machines. However, instead of helping doctors look inside the body to diagnose disease, the pulses of magnetic energy produce a stimulus in the brain that researchers believe causes positive changes In mood. The amount of energy delivered to the brain is very small and very focused. Study participants remain fully awake during the 45-minute outpatient procedure and can go about their normal activity before and after the procedure. TMS is performed without anesthesia or sedation, and it does not cause memory loss, as can occur with ECT, or the side effects common with oral antidepressants.
