by The Associated Press
(Washington) A novel machine designed to treat depression by zapping the brain with magnetic pulses shows no clear evidence of working, federal health advisers have concluded.
The device is called the Neurostar TMS, or transcranial magnetic stimulation, system. It uses magnetic energy to induce electrical currents in the region of the brain associated with mood.
Neuronetics Inc. believes those currents stimulate neurons in the region and relieve the symptoms of depression. The Malvern, Pa., company seeks clearance from the Food and Drug Administration to market the machine - something the panel's lukewarm reception may make less likely. The FDA isn't required to follow the advice of its outside experts, but it usually does.
A clinical trial of the device provided results that, in one analysis, suggested it's no better than sham treatment, according to FDA documents. Still, the FDA asked its neurological devices panel to review the overall safety and efficacy of the device.
Panelists said there was some suggestion the Neurostar works, but they called the effect marginal, borderline and questionable, an FDA spokeswoman said.
The company intends the device to be used by psychiatrists on an outpatient basis as an alternative to electroconvulsive therapy, or shock treatment, for the treatment of major depression. It would be used on depressed patients for whom therapy and antidepressants have not worked.
To gain federal approval, the FDA told Neuronetics that its device doesn't necessarily have to be as effective as shock treatment if it can be shown to be a safer treatment option. Shock therapy can cause memory and cognitive changes, as well as headaches and burns.
Panelists said there were no important safety issues with the Neurostar. But none of the experts said the device works as substantially well as does shock therapy.
Company spokesman Peter Anastasiou said the company was confident in its efficacy data.
"In our view, we showed efficacy in a very tough to treat patient population," Anastasiou said.