Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression

Not Applicable

Completed

Interventions: Device: NeoSync EEG Synchronization Therapy
Device: Sham NeoSync EEG Synchronization Therapy

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Active Fixed Alpha Frequency Magnetic Stimulation	NeoSync EEG Synchronization Therapy	Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
Inactive Sham Treatment	Sham NeoSync EEG Synchronization Therapy	Generate sound similar to active treatment, except that no magnetic field is generated.
Active Random Frequency Magnetic Stimulation	NeoSync EEG Synchronization Therapy	Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.

Primary Outcome Measures

Name	Time	Method
Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.	Assessed at baseline and the end of Week 4 of treatment.	Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment. The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression.

Secondary Outcome Measures