Andrew F Leuchter1, Ian A Cook2, David Feifel3, John W Goethe4, Mustafa Husain5, Linda L Carpenter6, Michael E Thase7, Andrew D Krystal8, Noah S Philip6, Mahendra T Bhati7, William J Burke9, Robert H Howland10, Yvette I Sheline11, Scott T Aaronson12, Dan V Iosifescu13, John P O'Reardon14, William S Gilmer15, Rakesh Jain16, Karl S Burgoyne17, Bill Phillips18, Paul J Manberg18, Joseph Massaro19, Aimee M Hunter2, Sarah H Lisanby8, Mark S George20. 1. 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. 2. 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. 3. Department of Psychiatry, UCSD School of Medicine, San Diego, CA, USA. 4. Institute of Living, Hartford Hospital, Hartford, CT, USA. 5. Department of Psychiatry, UT Southwestern Medical School, Dallas, TX, USA; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. 6. Department of Psychiatry and Human Behavior, Butler Hospital, Alpert Medical School of Brown University, Providence, RI, USA. 7. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 8. Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. 9. Department of Psychiatry, University of Nebraska School of Medicine, Omaha, NE, USA. 10. Department of Psychiatry, Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. 11. 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. 12. Sheppard Pratt Health System, Baltimore, MD, USA. 13. Department of Psychiatry, Icahn School of Medicine at Mt. Sinai, New York, NY, USA. 14. Department of Psychiatry, Rowan University School of Osteopathic Medicine, Stratford, NJ, USA. 15. Chicago TMS Specialists, Chicago, IL, USA. 16. RD Clinical Research, Lake Jackson, TX, USA. 17. Harbor-UCLA Medical Center, Torrance, CA, USA. 18. NeoSync, Inc., Waltham, MA, USA; NeoSync, Inc., Newport Beach, CA, USA. 19. Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA. 20. Department of Psychiatry, Medical University of South Carolina, and the Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
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/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.
RCT Entities:
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.
Authors: Zhi-De Deng; Bruce Luber; Nicholas L Balderston; Melbaliz Velez Afanador; Michelle M Noh; Jeena Thomas; William C Altekruse; Shannon L Exley; Shriya Awasthi; Sarah H Lisanby Journal: Annu Rev Pharmacol Toxicol Date: 2020-01-06 Impact factor: 13.820
Authors: Shawn M McClintock; Irving M Reti; Linda L Carpenter; William M McDonald; Marc Dubin; Stephan F Taylor; Ian A Cook; John O'Reardon; Mustafa M Husain; Christopher Wall; Andrew D Krystal; Shirlene M Sampson; Oscar Morales; Brent G Nelson; Vassilios Latoussakis; Mark S George; Sarah H Lisanby Journal: J Clin Psychiatry Date: 2018 Jan/Feb Impact factor: 4.384