Cervel Neurotech has initiated a clinical study for patients suffering from treatment resistant depression at seven leading academic and research centers in the US.
The 80-patient trial, designed as a randomized, sham-controlled, double blind study, intends to establish the safety and efficacy of the company's proprietary repetitive transcranial magnetic stimulation (rTMS) system.
The primary outcome, change in depression severity, will be measured by the Hamilton Rating Scale for Depression, a well-known and clinically validated measurement tool for depression.
The study is currently enrolling patients and more information about study participation can be found at www.cervel.com.
Cervel Neurotech founder and CMO Bret Schneider said throughout the world, there are many millions of people suffering from depression for whom medications are either ineffective or intolerable.
"The initiation of this study brings us one step closer to offering these patients an alternative treatment option free from the debilitating side effects of medication therapy," Schneider said.
Certain disorders, such as depression, are thought to occur because of disordered metabolic activity in a network of regions within the brain.
Transcranial magnetic stimulation (TMS) involves using pulsed magnetic fields to create small electrical currents that stimulate areas in the brain to restore metabolism.
Cervel's proprietary approach uses multiple magnetic fields, generated by coils placed on a patient's scalp, to selectively stimulate both superficial and deeper brain regions.
