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Efficacy and Safety of Low-field Synchronized Transcranial Magnetic Stimulation (sTMS) for Treatment of Major Depression.

Publication ,  Journal Article
Leuchter, AF; Cook, IA; Feifel, D; Goethe, JW; Husain, M; Carpenter, LL; Thase, ME; Krystal, AD; Philip, NS; Bhati, MT; Burke, WJ; Howland, RH ...
Published in: Brain Stimul
2015

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/HYPOTHESIS: 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.

Duke Scholars

Published In

Brain Stimul

DOI

EISSN

1876-4754

Publication Date

2015

Volume

8

Issue

4

Start / End Page

787 / 794

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transcranial Magnetic Stimulation
  • Psychiatric Status Rating Scales
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Humans
  • Female
  • Double-Blind Method
  • Depressive Disorder, Major
 

Citation

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MLA
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Leuchter, A. F., Cook, I. A., Feifel, D., Goethe, J. W., Husain, M., Carpenter, L. L., … George, M. S. (2015). Efficacy and Safety of Low-field Synchronized Transcranial Magnetic Stimulation (sTMS) for Treatment of Major Depression. Brain Stimul, 8(4), 787–794. https://doi.org/10.1016/j.brs.2015.05.005
Journal cover image

Published In

Brain Stimul

DOI

EISSN

1876-4754

Publication Date

2015

Volume

8

Issue

4

Start / End Page

787 / 794

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transcranial Magnetic Stimulation
  • Psychiatric Status Rating Scales
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Humans
  • Female
  • Double-Blind Method
  • Depressive Disorder, Major