Comparison of clinical outcomes with left unilateral and sequential bilateral Transcranial Magnetic Stimulation (TMS) treatment of major depressive disorder in a large patient registry

Background: It has been suggested that sequential bilateral (SBL) TMS, combining high frequency, left dorsolateral prefrontal cortex (DLPFC) stimulation and low frequency, right DLPFC stimulation, is more effective than unilateral TMS. Objective: To contrast treatment outcomes of left unilateral (LU...

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Main Authors: Scott T. Aaronson, Linda L. Carpenter, Todd M. Hutton, Stacia Kraus, Miriam Mina, Kenneth Pages, Luoxi Shi, W. Scott West, Harold A. Sackeim
Format: Article
Language:English
Published: Elsevier 2022-03-01
Series:Brain Stimulation
Online Access:http://www.sciencedirect.com/science/article/pii/S1935861X22000079
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author Scott T. Aaronson
Linda L. Carpenter
Todd M. Hutton
Stacia Kraus
Miriam Mina
Kenneth Pages
Luoxi Shi
W. Scott West
Harold A. Sackeim
author_facet Scott T. Aaronson
Linda L. Carpenter
Todd M. Hutton
Stacia Kraus
Miriam Mina
Kenneth Pages
Luoxi Shi
W. Scott West
Harold A. Sackeim
author_sort Scott T. Aaronson
collection DOAJ
description Background: It has been suggested that sequential bilateral (SBL) TMS, combining high frequency, left dorsolateral prefrontal cortex (DLPFC) stimulation and low frequency, right DLPFC stimulation, is more effective than unilateral TMS. Objective: To contrast treatment outcomes of left unilateral (LUL) and SBL protocols. Methods: Registry data were collected at 111 practice sites. Of 10,099 patients, 3,871 comprised a modified intent-to-treat (mITT) sample, defined as a primary MDD diagnosis, age ≥18, and PHQ-9 completion before TMS and at least one PHQ-9 assessment after baseline. The mITT sample received high frequency (10 Hz) LUL TMS exclusively (N = 3,327) or SBL TMS in at least 90% of sessions (N = 544). Completers (N = 3,049) were responders or had received ≥20 sessions and had an end of acute treatment PHQ-9 assessment. To control for site effects, a Matched sample (N = 653) included Completers at sites that used both protocols. To control for selection bias, the SBL group was also compared to a Restricted LUL group, drawn from sites where no patient switched to SBL after substantial exposure to LUL TMS. Secondary analyses were conducted on CGI-S ratings. Results: The LUL group had superior outcomes compared to the SBL group for multiple PHQ-9 and CGI-S continuous and categorical measures in the mITT, Completer and Matched samples, including in the specified primary analyses. However, outcome differences were not observed when comparing the Restricted LUL and SBL groups. Within SBL protocols, the LUL-RUL order had superior outcomes compared to the RUL-LUL order in all CGI-S, but not PHQ-9, measures. Conclusions: While limited by the naturalistic design, there was no evidence that SBL TMS was superior to LUL TMS. The sequential order of RUL TMS followed by LUL TMS may have reduced efficacy compared to LUL TMS followed by RUL TMS.
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spelling doaj.art-72a7383b567a446c8ca00a77234f22ff2022-12-21T20:05:17ZengElsevierBrain Stimulation1935-861X2022-03-01152326336Comparison of clinical outcomes with left unilateral and sequential bilateral Transcranial Magnetic Stimulation (TMS) treatment of major depressive disorder in a large patient registryScott T. Aaronson0Linda L. Carpenter1Todd M. Hutton2Stacia Kraus3Miriam Mina4Kenneth Pages5Luoxi Shi6W. Scott West7Harold A. Sackeim8Sheppard Pratt Health System, Baltimore, MD, USA; Department of Psychiatry, University of Maryland, Baltimore, MD, USA; Corresponding author. Sheppard Pratt Health System, Baltimore, MD, USA.Butler Hospital, Providence, RI, USA; Brown University Department of Psychiatry and Human Behavior, Providence, RI, USASouthern California TMS Center, Los Angeles, CA, USANAMSA, St. Louis Park, MN, USANeuronetics Inc, Malvern, PA, USATMS of South Tampa, Tampa, FL USA University, Augusta, GA, USANAMSA, St. Louis Park, MN, USANashville NeuroCare Therapy, Nashville, TN, USADepartment of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USABackground: It has been suggested that sequential bilateral (SBL) TMS, combining high frequency, left dorsolateral prefrontal cortex (DLPFC) stimulation and low frequency, right DLPFC stimulation, is more effective than unilateral TMS. Objective: To contrast treatment outcomes of left unilateral (LUL) and SBL protocols. Methods: Registry data were collected at 111 practice sites. Of 10,099 patients, 3,871 comprised a modified intent-to-treat (mITT) sample, defined as a primary MDD diagnosis, age ≥18, and PHQ-9 completion before TMS and at least one PHQ-9 assessment after baseline. The mITT sample received high frequency (10 Hz) LUL TMS exclusively (N = 3,327) or SBL TMS in at least 90% of sessions (N = 544). Completers (N = 3,049) were responders or had received ≥20 sessions and had an end of acute treatment PHQ-9 assessment. To control for site effects, a Matched sample (N = 653) included Completers at sites that used both protocols. To control for selection bias, the SBL group was also compared to a Restricted LUL group, drawn from sites where no patient switched to SBL after substantial exposure to LUL TMS. Secondary analyses were conducted on CGI-S ratings. Results: The LUL group had superior outcomes compared to the SBL group for multiple PHQ-9 and CGI-S continuous and categorical measures in the mITT, Completer and Matched samples, including in the specified primary analyses. However, outcome differences were not observed when comparing the Restricted LUL and SBL groups. Within SBL protocols, the LUL-RUL order had superior outcomes compared to the RUL-LUL order in all CGI-S, but not PHQ-9, measures. Conclusions: While limited by the naturalistic design, there was no evidence that SBL TMS was superior to LUL TMS. The sequential order of RUL TMS followed by LUL TMS may have reduced efficacy compared to LUL TMS followed by RUL TMS.http://www.sciencedirect.com/science/article/pii/S1935861X22000079
spellingShingle Scott T. Aaronson
Linda L. Carpenter
Todd M. Hutton
Stacia Kraus
Miriam Mina
Kenneth Pages
Luoxi Shi
W. Scott West
Harold A. Sackeim
Comparison of clinical outcomes with left unilateral and sequential bilateral Transcranial Magnetic Stimulation (TMS) treatment of major depressive disorder in a large patient registry
Brain Stimulation
title Comparison of clinical outcomes with left unilateral and sequential bilateral Transcranial Magnetic Stimulation (TMS) treatment of major depressive disorder in a large patient registry
title_full Comparison of clinical outcomes with left unilateral and sequential bilateral Transcranial Magnetic Stimulation (TMS) treatment of major depressive disorder in a large patient registry
title_fullStr Comparison of clinical outcomes with left unilateral and sequential bilateral Transcranial Magnetic Stimulation (TMS) treatment of major depressive disorder in a large patient registry
title_full_unstemmed Comparison of clinical outcomes with left unilateral and sequential bilateral Transcranial Magnetic Stimulation (TMS) treatment of major depressive disorder in a large patient registry
title_short Comparison of clinical outcomes with left unilateral and sequential bilateral Transcranial Magnetic Stimulation (TMS) treatment of major depressive disorder in a large patient registry
title_sort comparison of clinical outcomes with left unilateral and sequential bilateral transcranial magnetic stimulation tms treatment of major depressive disorder in a large patient registry
url http://www.sciencedirect.com/science/article/pii/S1935861X22000079
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