BACKGROUND:Low-Field Magnetic Stimulation (LFMS) is a novel, non-invasive, sub-threshold neuromodulation technique, shown in preliminary studies to have immediate mood elevating effects in both unipolar and bipolar depressed patients. OBJECTIVE: We aimed to assess the antidepressant augmentation effects at 48 h of LFMS administered on two consecutive days compared to sham treatment in treatment resistant depression (TRD) subjects, using the Sequential Parallel Comparison Design (SPCD). METHODS:Eighty-four eligible subjects with TRD were randomly assigned to double-blind treatment with LFMS 20 min/day for four days, sham treatment 20 min/day for four days, or sham treatment 20 min/day for 2 days followed by LFMS treatment 20 min/day for two days, using the pre-randomization version of the SPCD (randomization 1:1:1). The SPCD analyses used a repeated measures linear modeling approach with maximum likelihood estimation to use all available data, and using a 60-40 weighting of Stage 1 vs. 2 responses, with the primary outcome being measured after 2 and 4 days. RESULTS: Both primary and secondary outcome measures consistently showed no differences between LFMS-treated patients and those treated with sham, with the exception of a slight, non-significantly greater improvement than sham in the visual analogue scale (VAS) sad mood on LFMS-treated patients. LFMS treatment was relatively well tolerated. CONCLUSIONS: We did not observe a significantly greater, rapid efficacy of LFMS compared to sham therapy. Future studies need to examine the possible therapeutic effects of more intensive forms of LFMS, as other forms of neurostimulation typically require longer duration of exposure.
RCT Entities:
BACKGROUND: Low-Field Magnetic Stimulation (LFMS) is a novel, non-invasive, sub-threshold neuromodulation technique, shown in preliminary studies to have immediate mood elevating effects in both unipolar and bipolar depressedpatients. OBJECTIVE: We aimed to assess the antidepressant augmentation effects at 48 h of LFMS administered on two consecutive days compared to sham treatment in treatment resistant depression (TRD) subjects, using the Sequential Parallel Comparison Design (SPCD). METHODS: Eighty-four eligible subjects with TRD were randomly assigned to double-blind treatment with LFMS 20 min/day for four days, sham treatment 20 min/day for four days, or sham treatment 20 min/day for 2 days followed by LFMS treatment 20 min/day for two days, using the pre-randomization version of the SPCD (randomization 1:1:1). The SPCD analyses used a repeated measures linear modeling approach with maximum likelihood estimation to use all available data, and using a 60-40 weighting of Stage 1 vs. 2 responses, with the primary outcome being measured after 2 and 4 days. RESULTS: Both primary and secondary outcome measures consistently showed no differences between LFMS-treated patients and those treated with sham, with the exception of a slight, non-significantly greater improvement than sham in the visual analogue scale (VAS) sad mood on LFMS-treated patients. LFMS treatment was relatively well tolerated. CONCLUSIONS: We did not observe a significantly greater, rapid efficacy of LFMS compared to sham therapy. Future studies need to examine the possible therapeutic effects of more intensive forms of LFMS, as other forms of neurostimulation typically require longer duration of exposure.
Authors: Ross J Baldessarini; Alberto Forte; Valerio Selle; Kang Sim; Leonardo Tondo; Juan Undurraga; Gustavo H Vázquez Journal: Psychother Psychosom Date: 2017-02-10 Impact factor: 17.659
Authors: John P O'Reardon; H Brent Solvason; Philip G Janicak; Shirlene Sampson; Keith E Isenberg; Ziad Nahas; William M McDonald; David Avery; Paul B Fitzgerald; Colleen Loo; Mark A Demitrack; Mark S George; Harold A Sackeim Journal: Biol Psychiatry Date: 2007-06-14 Impact factor: 13.382
Authors: Michael E Thase; James M Youakim; Aleksandar Skuban; Mary Hobart; Carole Augustine; Peter Zhang; Robert D McQuade; William H Carson; Margaretta Nyilas; Raymond Sanchez; Hans Eriksson Journal: J Clin Psychiatry Date: 2015-09 Impact factor: 4.384
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: Marc J Dubin; Irena P Ilieva; Zhi-De Deng; Jeena Thomas; Ashly Cochran; Kamilla Kravets; Benjamin D Brody; Paul J Christos; James H Kocsis; Conor Liston; Faith M Gunning Journal: J Affect Disord Date: 2019-02-14 Impact factor: 4.839
Authors: John M Zajecka; Arielle D Stanford; Asli Memisoglu; William F Martin; Sanjeev Pathak Journal: Neuropsychiatr Dis Treat Date: 2019-04-04 Impact factor: 2.570