PMID- 36692954
OWN - NLM
STAT- MEDLINE
DCOM- 20230224
LR  - 20230309
IS  - 2379-3708 (Electronic)
IS  - 2379-3708 (Linking)
VI  - 8
IP  - 4
DP  - 2023 Feb 22
TI  - Pursuing personalized medicine for depression by targeting the lateral or medial 
      prefrontal cortex with Deep TMS.
LID - 10.1172/jci.insight.165271 [doi]
LID - e165271
AB  - BACKGROUNDMajor depressive disorder (MDD) can benefit from novel interventions 
      and personalization. Deep transcranial magnetic stimulation (Deep TMS) targeting 
      the lateral prefrontal cortex (LPFC) using the H1 coil was FDA cleared for 
      treatment of MDD. However, recent preliminary data indicate that targeting the 
      medial prefrontal cortex (MPFC) using the H7 coil might induce outcomes that are 
      as good or even better. Here, we explored whether Deep TMS targeting the MPFC is 
      noninferior to targeting the LPFC and whether electrophysiological or clinical 
      markers for patient selection can be identified.METHODSThe present prospective, 
      multicenter, randomized study enrolled 169 patients with MDD for whom 
      antidepressants failed in the current episode. Patients were randomized to 
      receive 24 Deep TMS sessions over 6 weeks, using either the H1 coil or the H7 
      coil. The primary efficacy endpoint was the change from baseline to week 6 in 
      Hamilton Depression Rating Scale scores.RESULTSClinical efficacy and safety 
      profiles were similar and not significantly different between groups, with 
      response rates of 60.9% for the H1 coil and 64.2% for the H7 coil. Moreover, 
      brain activity measured by EEG during the first treatment session correlated with 
      clinical outcomes in a coil-specific manner, and a cluster of baseline clinical 
      symptoms was found to potentially distinguish between patients who can benefit 
      from each Deep TMS target.CONCLUSIONThis study provides a treatment option for 
      MDD, using the H7 coil, and initial guidance to differentiate between patients 
      likely to respond to LPFC versus MPFC stimulation targets, which require further 
      validation studies.TRIAL REGISTRATIONClinicalTrials.gov 
      NCT03012724.FUNDINGBrainsWay Ltd.
FAU - Zangen, Abraham
AU  - Zangen A
AD  - Ben-Gurion University of the Negev, Beer-Sheva, Israel.
FAU - Zibman, Samuel
AU  - Zibman S
AD  - Ben-Gurion University of the Negev, Beer-Sheva, Israel.
FAU - Tendler, Aron
AU  - Tendler A
AD  - Advanced Mental Health Care Inc., Royal Palm Beach, Florida, USA.
FAU - Barnea-Ygael, Noam
AU  - Barnea-Ygael N
AD  - Ben-Gurion University of the Negev, Beer-Sheva, Israel.
FAU - Alyagon, Uri
AU  - Alyagon U
AD  - Ben-Gurion University of the Negev, Beer-Sheva, Israel.
FAU - Blumberger, Daniel M
AU  - Blumberger DM
AD  - Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and 
      Mental Health, and Department of Psychiatry, University of Toronto, Toronto, 
      Ontario, Canada.
FAU - Grammer, Geoffrey
AU  - Grammer G
AD  - Greenbrook TMS NeuroHealth, McLean, Virginia, USA.
FAU - Shalev, Hadar
AU  - Shalev H
AD  - Ben-Gurion University of the Negev, Beer-Sheva, Israel.
AD  - Department of Psychiatry, Soroka Medical Center, Beer-Sheva, Israel.
FAU - Gulevski, Tatiana
AU  - Gulevski T
AD  - Ben-Gurion University of the Negev, Beer-Sheva, Israel.
FAU - Vapnik, Tanya
AU  - Vapnik T
AD  - Pacific Institute of Medical Research, Los Angeles, California, USA.
FAU - Bystritsky, Alexander
AU  - Bystritsky A
AD  - Pacific Institute of Medical Research, Los Angeles, California, USA.
FAU - Filipcic, Igor
AU  - Filipcic I
AD  - Psychiatric Hospital Sveti Ivan and School of Medicine, University of Zagreb, 
      Zagreb, Croatia.
FAU - Feifel, David
AU  - Feifel D
AD  - Kadima Neuropsychiatry Institute, La Jolla, California, USA.
FAU - Stein, Ahava
AU  - Stein A
AD  - A. Stein - Regulatory Affairs Consulting Ltd, Kfar Saba, Israel.
FAU - Deutsch, Frederic
AU  - Deutsch F
AD  - BioStats Statistical Consulting Ltd., Modiin, Israel.
FAU - Roth, Yiftach
AU  - Roth Y
AD  - Ben-Gurion University of the Negev, Beer-Sheva, Israel.
FAU - George, Mark S
AU  - George MS
AD  - Medical University of South Carolina, Columbia, South Carolina, USA.
AD  - Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03012724
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230222
PL  - United States
TA  - JCI Insight
JT  - JCI insight
JID - 101676073
SB  - IM
MH  - Humans
MH  - *Transcranial Magnetic Stimulation
MH  - *Depression
MH  - Treatment Outcome
MH  - Precision Medicine
MH  - Prospective Studies
MH  - Prefrontal Cortex/physiology
PMC - PMC9977507
OTO - NOTNLM
OT  - Behavior
OT  - Clinical Trials
OT  - Depression
OT  - Neuroimaging
OT  - Neuroscience
COIS- Conflict of interest: AZ and YR are inventors of Deep TMS coils and have 
      financial interest in BrainsWay Ltd. AT serves as the chief medical officer of 
      BrainsWay Ltd. UA is an EEG consultant for BrainsWay Ltd. MSG, who was the local 
      principal investigator of the trial at Medical University of South Carolina, is a 
      member of the BrainsWay scientific advisory board.
EDAT- 2023/01/25 06:00
MHDA- 2023/02/25 06:00
PMCR- 2023/02/22
CRDT- 2023/01/24 12:02
PHST- 2022/09/12 00:00 [received]
PHST- 2023/01/05 00:00 [accepted]
PHST- 2023/01/25 06:00 [pubmed]
PHST- 2023/02/25 06:00 [medline]
PHST- 2023/01/24 12:02 [entrez]
PHST- 2023/02/22 00:00 [pmc-release]
AID - 165271 [pii]
AID - 10.1172/jci.insight.165271 [doi]
PST - epublish
SO  - JCI Insight. 2023 Feb 22;8(4):e165271. doi: 10.1172/jci.insight.165271.