title: Efficacy and Safety of Low-field Synchronized Transcranial Magnetic Stimulation (sTMS) for Treatment of Major Depression.
abstract: BACKGROUND
  Transcranial Magnetic Stimulation (TMS) customarily uses high-field electromagnets to achieve therapeutic efficacy in Major Depressive Disorder (MDD). Low-field magnetic stimulation also may be useful for treatment of MDD, with fewer treatment-emergent adverse events.
  
  
  OBJECTIVE
  To examine efficacy, safety, and tolerability of low-field magnetic stimulation synchronized to an individual's alpha frequency (IAF) (synchronized TMS, or sTMS) for treatment of MDD.
  
  
  METHODS
  Six-week double-blind sham-controlled treatment trial of a novel device that used three rotating neodymium magnets to deliver sTMS treatment. IAF was determined from a single-channel EEG prior to first treatment. Subjects had baseline 17-item Hamilton Depression Rating Scale (HamD17) ≥ 17.
  
  
  RESULTS
  202 subjects comprised the intent-to-treat (ITT) sample, and 120 subjects completed treatment per-protocol (PP). There was no difference in efficacy between active and sham in the ITT sample. Subjects in the PP sample (N = 59), however, had significantly greater mean decrease in HamD17 than sham (N = 60) (-9.00 vs. -6.56, P = 0.033). PP subjects with a history of poor response or intolerance to medication showed greater improvement with sTMS than did treatment-naïve subjects (-8.58 vs. -4.25, P = 0.017). Efficacy in the PP sample reflects exclusion of subjects who received fewer than 80% of scheduled treatments or were inadvertently treated at the incorrect IAF; these subgroups failed to separate from sham. There was no difference in adverse events between sTMS and sham, and no serious adverse events attributable to sTMS.
  
  
  CONCLUSIONS
  Results suggest that sTMS may be effective, safe, and well tolerated for treating MDD when administered as intended.
authors.affiliation: Department of Psychiatry and Biobehavioral Sciences and Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: afl@ucla.edu.
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Leuchter
authors.affiliation: Department of Psychiatry and Biobehavioral Sciences and Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
authors.forename: Ian A
authors.initials: IA
authors.lastname: Cook
authors.affiliation: Department of Psychiatry, UCSD School of Medicine, San Diego, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Feifel
authors.affiliation: Institute of Living, Hartford Hospital, Hartford, CT, USA.
authors.forename: John W
authors.initials: JW
authors.lastname: Goethe
authors.affiliation: Department of Psychiatry, UT Southwestern Medical School, Dallas, TX, USA; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Mustafa
authors.initials: M
authors.lastname: Husain
authors.affiliation: Department of Psychiatry and Human Behavior, Butler Hospital, Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Carpenter
authors.affiliation: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Krystal
authors.affiliation: Department of Psychiatry and Human Behavior, Butler Hospital, Alpert Medical School of Brown University, Providence, RI, USA.
authors.forename: Noah S
authors.initials: NS
authors.lastname: Philip
authors.affiliation: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Mahendra T
authors.initials: MT
authors.lastname: Bhati
authors.affiliation: Department of Psychiatry, University of Nebraska School of Medicine, Omaha, NE, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Burke
authors.affiliation: Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Howland
authors.affiliation: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Department of Psychiatry, School of Medicine, Washington University, St. Louis, MO, USA.
authors.forename: Yvette I
authors.initials: YI
authors.lastname: Sheline
authors.affiliation: Sheppard Pratt Health System, Baltimore, MD, USA.
authors.forename: Scott T
authors.initials: ST
authors.lastname: Aaronson
authors.affiliation: Department of Psychiatry, Icahn School of Medicine at Mt. Sinai, New York, NY, USA.
authors.forename: Dan V
authors.initials: DV
authors.lastname: Iosifescu
authors.affiliation: Department of Psychiatry, Rowan University School of Osteopathic Medicine, Stratford, NJ, USA.
authors.forename: John P
authors.initials: JP
authors.lastname: O'Reardon
authors.affiliation: Chicago TMS Specialists, Chicago, IL, USA.
authors.forename: William S
authors.initials: WS
authors.lastname: Gilmer
authors.affiliation: RD Clinical Research, Lake Jackson, TX, USA.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Jain
authors.affiliation: Harbor-UCLA Medical Center, Torrance, CA, USA.
authors.forename: Karl S
authors.initials: KS
authors.lastname: Burgoyne
authors.affiliation: NeoSync, Inc., Waltham, MA, USA; NeoSync, Inc., Newport Beach, CA, USA.
authors.forename: Bill
authors.initials: B
authors.lastname: Phillips
authors.affiliation: NeoSync, Inc., Waltham, MA, USA; NeoSync, Inc., Newport Beach, CA, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Manberg
authors.affiliation: Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Massaro
authors.affiliation: Department of Psychiatry and Biobehavioral Sciences and Neuromodulation Division, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
authors.forename: Aimee M
authors.initials: AM
authors.lastname: Hunter
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Sarah H
authors.initials: SH
authors.lastname: Lisanby
authors.affiliation: Department of Psychiatry, Medical University of South Carolina, and the Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
authors.forename: Mark S
authors.initials: MS
authors.lastname: George
mesh_terms: D003865:Major Depressive Disorder / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D050781:Transcranial Magnetic Stimulation / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
keywords: Alpha oscillations; Clinical treatment trial; Electroencephalogram (EEG); Individual Alpha Frequency (IAF); Low-intensity magnetic field; Major Depressive Disorder; Neuromodulation; Oscillatory synchrony; Static magnet; Synchronized Transcranial Magnetic Stimulation (sTMS)