As part of an NIMH program aimed at identifying and testing rapidly acting treatments for treatment-resistant depression, an experimental low-field magnetic stimulation (LFMS) technology developed by TAL Medical (Boston) has been selected as the first trial candidate in the Rapidly Acting Treatments for Treatment Resistant Depression (RAPID) program, which was created by the National Institute of Mental Health (NIMH).
Tal's LFMS device is based on a discovery from McLean Hospital (Belmont, Mass.). Like other “neuromodulation” techniques, including transcranial magnetic stimulation (TMS), LFMS is delivered non-invasively, through an electromagnetic coil that surrounds the head. Unlike TMS, however, the strength of the magnetic field delivered by LFMS is dramatically lower, below the threshold level that causes neurons to fire. A sham-controlled neuroimaging study also indicated that treated patients indicated an immediate physiological response to the treatment (decreased glucose utilization in neurons). This result contrasts with TMS, which increases glucose utilization over the course of repeated treatments.
"LFMS has the potential to offer patients a clinical profile completely different from that of current therapies," said Steve Paul, M.D., the Chairman and a Co-founder of Tal. "The sham-controlled data with LFMS indicate an antidepressant response within minutes of patients receiving a single 20 minute LFMS treatment." Before joining TAL Medical, Dr. Paul was President of Lilly Research Laboratories at Eli Lilly and Company, where his teams led the development and launch of the current market leading antidepressant, Cymbalta, along with other psychiatric medicines. However, currently available antidepressant medications require two or more weeks to work and may not be effective.
"A therapy that acts quickly would be a major step forward for the field given the significant time lag to onset of current therapies" said Maurizio Fava, MD, Executive Vice Chair of the Department of Psychiatry at the Massachusetts General Hospital (MGH) and Executive Director of the MGH Clinical Trials Network and Institute.
NIMH is funding a 90-subject proof-of-concept study comparing LFMS to sham treatment to assess its rapid antidepressant efficacy in patients with treatment resistant Major Depressive Disorder. The MGH was awarded National Institute of Mental Health contract to conduct the multi-site clinical trials as part of the RAPID program. The LFMS RAPID trial is currently recruiting patients (www.clinicaltrials.gov) at The Massachusetts General Hospital, Yale University, Mount Sinai School of Medicine, The University of Texas-Southwestern Medical Center, Emory University and the University of Alabama-Birmingham.