Clinical trial NCT01683019: Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: Depression
magnetic field
alpha frequency
EEG
NeoSync EEG Synchronization Therapy
Lead sponsor: Wave Neuroscience
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.
timeFrame: Assessed at baseline and the end of Week 4 of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Amen Clinic
state: California
city: Beijing
country: China
facility: Institute of Mental Health, Peking University
Study officials:
References:
citation: Jin Y, Phillips B. A pilot study of the use of EEG-based synchronized Transcranial Magnetic Stimulation (sTMS) for treatment of Major Depression. BMC Psychiatry. 2014 Jan 18;14:13. doi: 10.1186/1471-244X-14-13.