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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Major Depressive Disorder (MDD)

Intervention / Treatment
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* Device: NeoSync EEG Synchronization Therapy
* Device: Sham NeoSync EEG Synchronization Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Fixed Alpha Frequency Magnetic Stimulation<br>Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF). | Device: NeoSync EEG Synchronization Therapy<br>* 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.<br>|
| Active Comparator: Active Random Frequency Magnetic Stimulation<br>Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second. | Device: NeoSync EEG Synchronization Therapy<br>* 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.<br>|
| Sham Comparator: Inactive Sham Treatment<br>Generate sound similar to active treatment, except that no magnetic field is generated. | Device: Sham NeoSync EEG Synchronization Therapy<br>* A device that looks and sounds similar to the active treatment, but no magnetic field is generated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Hamilton Depression Rating Scale (HAMD-17) 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. | Assessed at baseline and the end of Week 4 of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, magnetic field, alpha frequency, EEG, NeoSync EEG Synchronization Therapy