FDAnews Device Daily Bulletin
Medical Devices / Research and Development

NIMH Selects Tal Medical’s Low Field Magnetic Stimulation Device for RAPID Program

Jan. 13, 2014

The National Institute of Mental Health has selected Tal Medical’s low field magnetic stimulation device as the first in its Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID) Program.

Tal’s as-yet-unnamed device utilizes a cylindrical magnetic coil approximately 15 inches in diameter that can be placed on a patient’s forehead, where it produces a time-varying magnetic field to induce a time-varying electrical field in the brain.

NIMH will fund a 90-patient proof-of-concept trial comparing Tal’s device to a sham treatment in patients with major depressive disorder who have not responded to up to three different treatments. Patients will be treated in 20-minute sessions up to four times in four days. After 28 days, investigators will judge the device’s effectiveness based on a follow-up appointment.

Boston-based Tal expects the trial to be completed sometime this year.

RAPID aims to support development of therapies for treatment-resistant depression that take effect within 72 hours. According to NIMH, most currently available depression therapies take weeks to become effective, and half of patients fail to respond to them at all. — Lena Freund

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