NCT01683019

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

A MULTICENTER, RANDOMIZED, BLINDED, SHAM CONTROLLED, PARALLEL GROUP TRIAL TO TEST CLINICAL EFFICACY OF LOW FREQUENCY AC MAGNETIC FIELD INDUCED EEG SYNCHRONIZATION IN MAJOR DEPRESSION

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Wave Neuroscience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DEVICE	NeoSync EEG Synchronization Therapy	Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.
DEVICE	Sham NeoSync EEG Synchronization Therapy	A device that looks and sounds similar to the active treatment, but no magnetic field is generated.

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2012-09-11
• Last updated: 2018-12-07
• Results posted: 2014-05-05

Locations

2 sites across 2 countries: United States, China

Regulatory

• FDA-regulated device study