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

Major Depressive Disorder (MDD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683019
• Other study ID #: NST#002
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2018
• Source: NeoSync, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Intervention

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.
• Sham NeoSync EEG Synchronization Therapy
A device that looks and sounds similar to the active treatment, but no magnetic field is generated.

Locations

Country	Name	City	State
China	Institute of Mental Health, Peking University	Beijing
United States	Amen Clinic	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
NeoSync, Inc.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.