Alvaro Pascual-Leone MD PhD
Your gift at work: 
Stamp of Approval
Unique treatment gets FDA's OK
All doctors believe that providing the best treatment possible, regardless of cost, is essential, and neurologist Alvaro Pascual-Leone, MD, PhD, is no exception.
As director of the Berenson-Allen Center for Noninvasive Brain Stimulation at BIDMC, Pascual-Leone is making transcranial magnetic stimulation (TMS)—a revolutionary noninvasive technique with potential therapeutic applications for a host of neurological disorders—more accessible to the masses.* The recent approval by the U.S. Food and Drug Administration (FDA) to use TMS to treat patients suffering from medication-resistant depression has brought him that much closer to his goal.
“There are lots of patients who could benefit from TMS but cannot afford to pay,” says Pascual-Leone, a world expert on the technique, which uses magnetic fields to ultimately stimulate or suppress specific nerve cell activity in the brain. “Getting approval is an important first step.” Indeed, most insurance companies wouldn’t consider a therapy for reimbursement without it.
In this case, the FDA specifically sanctioned the NeuroStar® Transcranial Magnetic Stimulation Therapy System, a product of Neuronetics Inc., a medical device company which led a multi-center clinical study culminating in the approval. Several physicians involved in the trial were trained in the foundations and research applications of TMS at BIDMC in a joint course between the Berenson-Allen Center and Harvard Medical School.
“BIDMC is home to the first TMS course in the world,” says Pascual-Leone. “We are committed to expanding our clinical program to help as many patients as possible, and we will also expand our course to train clinicians in the safe and effective use of TMS. It is vital that we make sure that TMS is applied by properly trained individuals to maximize its safety and efficacy and promote its embrace by the medical community.”
