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

Wave Neuroscience

Status: Completed

Conditions: Major Depressive Disorder (MDD)

Treatments: Device: Sham NeoSync EEG Synchronization Therapy; Device: NeoSync EEG Synchronization Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01683019

NST#002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 3 patient groups

Active Fixed Alpha Frequency Magnetic Stimulation

Active Comparator group

Description:

Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).

Treatment:

Device: NeoSync EEG Synchronization Therapy

Active Random Frequency Magnetic Stimulation

Active Comparator group

Description:

Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.

Treatment:

Device: NeoSync EEG Synchronization Therapy

Inactive Sham Treatment

Sham Comparator group

Description:

Generate sound similar to active treatment, except that no magnetic field is generated.

Treatment:

Device: Sham NeoSync EEG Synchronization Therapy