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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeoSync, Inc.
ClinicalTrials.gov Identifier:
NCT01683019
First received: September 4, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder (MDD)
Device: NeoSync EEG Synchronization Therapy
Device: Sham NeoSync EEG Synchronization Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by NeoSync, Inc.:

Primary Outcome Measures:
  • Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. [ Time Frame: Assessed at baseline and the end of Week 4 of treatment. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Safety Profile of the Treatment [ Time Frame: Outcome assessed at the end of the 4th week of treatment. ] [ Designated as safety issue: Yes ]
    Describe the safety profile of the administration of low-emission sinusoidal magnetic fields above the subject's scalp. Safety criteria include adverse events, serious adverse events, and vital signs.


Enrollment: 52
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Fixed Alpha Frequency Magnetic Stimulation
Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
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.
Active Comparator: Active Random Frequency Magnetic Stimulation
Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.
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 Comparator: Inactive Sham Treatment
Generate sound similar to active treatment, except that no magnetic field is generated.
Device: Sham NeoSync EEG Synchronization Therapy
A device that looks and sounds similar to the active treatment, but no magnetic field is generated.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683019

Locations
United States, California
Amen Clinic
Newport Beach, California, United States, 92660
China
Institute of Mental Health, Peking University
Beijing, China
Sponsors and Collaborators
NeoSync, Inc.
Investigators
Principal Investigator: Yi Jin, MD NeoSync, Inc.
  More Information

No publications provided by NeoSync, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NeoSync, Inc.
ClinicalTrials.gov Identifier: NCT01683019     History of Changes
Other Study ID Numbers: NST#002
Study First Received: September 4, 2012
Results First Received: October 28, 2013
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NeoSync, Inc.:
Depression
magnetic field
alpha frequency
EEG
NeoSync EEG Synchronization Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 27, 2014