Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression
Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression
This feasibility study investigates effects of EEG-based low frequency, low emission magnetic
 cortical stimulation in comparison to a sham treatment in subjects with moderate to severe
 depressive disorder.
Major Depressive Disorder (MDD) is associated with functional impairment and disability, and
 results in a significant burden on the affected individual, his or her family, and society in
 general. Psychopharmacological therapy has been shown to be effective, but may be accompanied
 by significant side effects. The investigators propose an alternative model, based on the
 relationship between symptoms, brain metabolism, and neural activity as recorded with
 electroencephalography (EEG). Subjects with MDD often have decreased brain metabolism,
 accompanied by increased EEG activity in the alpha band. The investigators hypothesis is that
 a gentle, non-significant risk, sinusoidal magnetic field above the subject's scalp, which
 oscillates at precisely his or her Intrinsic Alpha Frequency (IAF) can take advantage of this
 relationship to reduce symptoms without the significant side effects associated with
 pharmaceuticals. The investigators propose a 4-week, sham controlled, randomized,
 double-blind multi-center feasibility study to determine the efficacy of synchronized low
 energy magnetic fields delivered at the subject's IAF to treat MDD. Treatment will be given
 concomitant to the subject's existing medication, and will occur 5 days per week at the
 clinical site. Target enrollment is 45 adult subjects diagnosed with MDD.
Inclusion Criteria:

 -  18 years of age or older

 -  Diagnosis of MDD with HAMD-17 greater than or equal to 17

 -  On a stable dose of existing medication or no medication for 1 month or longer prior
 to the study

 Exclusion Criteria:

 -  Diagnosed with another primary Axis I illness

 -  Recent history of or current substance abuse

 -  Clinically significant medical illness, including any thyroid disorders

 -  Known pregnancy and/or lactation, or intent to become pregnant during the study