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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01683019
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : May 5, 2014
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
NeoSync, Inc.

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 11, 2012
Results First Submitted Date  ICMJE October 28, 2013
Results First Posted Date  ICMJE May 5, 2014
Last Update Posted Date December 7, 2018
Study Start Date  ICMJE June 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
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. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
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. ]
Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent reduction in severity score from baseline until the end of the 4th week of treatment.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
Safety Profile of the Treatment [ Time Frame: Outcome assessed at the end of the 4th week of treatment. ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder (MDD)
Intervention  ICMJE
  • 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.
  • Device: Sham NeoSync EEG Synchronization Therapy
    A device that looks and sounds similar to the active treatment, but no magnetic field is generated.
Study Arms  ICMJE
  • Active Comparator: Active Fixed Alpha Frequency Magnetic Stimulation
    Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).
    Intervention: Device: NeoSync EEG Synchronization Therapy
  • Active Comparator: Active Random Frequency Magnetic Stimulation
    Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.
    Intervention: Device: NeoSync EEG Synchronization Therapy
  • Sham Comparator: Inactive Sham Treatment
    Generate sound similar to active treatment, except that no magnetic field is generated.
    Intervention: Device: Sham NeoSync EEG Synchronization Therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2014)
52
Original Actual Enrollment  ICMJE
 (submitted: September 6, 2012)
45
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01683019
Other Study ID Numbers  ICMJE NST#002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NeoSync, Inc.
Study Sponsor  ICMJE NeoSync, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NeoSync, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP