PMID- 38325159
OWN - NLM
STAT- MEDLINE
DCOM- 20240219
LR  - 20240219
IS  - 1872-7123 (Electronic)
IS  - 0165-1781 (Linking)
VI  - 333
DP  - 2024 Mar
TI  - Amygdala-derived-EEG-fMRI-pattern neurofeedback for the treatment of chronic 
      post-traumatic stress disorder. A prospective, multicenter, multinational study 
      evaluating clinical efficacy.
PG  - 115711
LID - S0165-1781(23)00661-3 [pii]
LID - 10.1016/j.psychres.2023.115711 [doi]
AB  - We conducted a prospective, single arm, multisite, multinational, open label 
      trial assessing the safety and efficacy of a novel amygdala derived neurofeedback 
      treatment, designated Amygdala-Derived-EFP, for chronic PTSD. Participants, 
      including veterans and civilians, underwent screening, training, 15 neurofeedback 
      sessions over 8 weeks and; baseline, termination (8 weeks) and 3 month post 
      treatment assessments with validated measures. The primary endpoint was more than 
      50 % of the participants demonstrating a Minimally Clinically Important 
      Difference (MCID) defined as a 6-point reduction, on the Clinician Administered 
      PTSD Scale (CAPS-5) total score at 3 months. Secondary measures included the 
      PCL-5, ERQ, PHQ-9, and CGI. Statistical analyses were performed using SAS(R)V9.4. 
      The primary endpoint was met, with a CAPS-5 MCID response rate of 66.7 %. The 
      average reduction in CAPS-5 total scores at 3 month follow up was 13.5 points, 
      more than twice the MCID. Changes from baseline in CAPS-5, PCL-5, PHQ-9 scores at 
      8 weeks and the 3 month follow-up demonstrated statistically significant 
      improvements in response and; demonstrated effect sizes ranging from 0.46 to 
      1.07. Adverse events were mild and resolved after treatment. This study builds on 
      prior research demonstrating similar outcomes using amygdala-derived 
      neurofeedback. Positive attributes of this therapy include monitoring by 
      non-physician personnel, affordability, accessibility, and tolerability.
CI  - Copyright (c) 2024 The Author(s). Published by Elsevier B.V. All rights reserved.
FAU - Fruchter, Eyal
AU  - Fruchter E
AD  - Rambam Medical Center, Bruss Rapaport Faculty of Medicine - Technicon - Haifa, 
      Haifa, Israel.
FAU - Goldenthal, Nadav
AU  - Goldenthal N
AD  - Division of Psychiatry, Chaim Sheba Medical Center, Tel Hashomer, Israel.
FAU - Adler, Lenard A
AU  - Adler LA
AD  - Department Psychiatry, New York University Grossman School of Medicine, NY, NY, 
      United States.
FAU - Gross, Raz
AU  - Gross R
AD  - Department of Epidemiology, School of Public Health and Department of Psychiatry, 
      School of Medicine, Tel Aviv University, Sheba Medical Center, Tel Aviv, Isreal.
FAU - Harel, Eiran V
AU  - Harel EV
AD  - Be'er Ya'akov Mental Health Center, Tel Aviv, Israel.
FAU - Deutsch, Lisa
AU  - Deutsch L
AD  - BioStats Statistical Consulting Ltd., Israel.
FAU - Nacasch, Nitsa
AU  - Nacasch N
AD  - Division of Psychiatry, Chaim Sheba Medical Center, Tel Hashomer, Israel.
FAU - Grinapol, Shulamit
AU  - Grinapol S
AD  - Department of Community Mental Health, University of Haifa, Haifa, Israel.
FAU - Amital, Daniela
AU  - Amital D
AD  - Division of Psychology, Barzilai Medical Center, Ashkelon, Israel.
FAU - Voigt, Jeffrey D
AU  - Voigt JD
AD  - 41 West Prospect St, Waldwick, NJ, 07463, United States. Electronic address: 
      meddevconsultant@aol.com.
FAU - Marmar, Charles R
AU  - Marmar CR
AD  - Department Psychiatry, New York University Grossman School of Medicine, NY, NY, 
      United States.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20240108
PL  - Ireland
TA  - Psychiatry Res
JT  - Psychiatry research
JID - 7911385
SB  - IM
MH  - Humans
MH  - *Stress Disorders, Post-Traumatic/diagnosis
MH  - *Neurofeedback
MH  - Magnetic Resonance Imaging
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Amygdala/diagnostic imaging
MH  - *Veterans
MH  - Electroencephalography
OTO - NOTNLM
OT  - Biofeedback
OT  - Clinician administered PTSD scale
OT  - Self-learning
COIS- Declaration of competing interest Jeffrey Voigt is a reimbursement consultant for 
      GrayMatters, the developer and manufacturer of the Prism technology. Charles 
      Marmar has received support from: National Institute on Alcohol Abuse and 
      Alcoholism, National Institute of Mental Health, Department of Defense- CDMRP * 
      US Army Research Office * DARPA, Bank of America Foundation, Brockman Foundation, 
      Cohen Veterans Bioscience, Cohen Veterans Network, McCormick Foundation, Home 
      Depot Foundation, New York City Council, New York State Health, Mother Cabrini 
      Foundation, Tilray Pharmaceuticals, and Ananda Scientific. Lenard Adler has 
      received support from: Supernus Pharmaceuticals, Otsuka Pharmaceuticals, 
      Bracket/Signant, SUNY and, Takeda Pharmaceuticals. Len Adler also receives 
      royalties as an inventor from licensing agreements with the NYU Grossman School 
      of Medicine. Lisa Deutsch is a statistician for hire and received compensation 
      from GrayMatters for statistical analysis. Nadav Goldenthal and Raz Gross receive 
      research support from GrayMatters. Eyal Fruchter, Shulamit Grinapol, Amital 
      Daniela, Nitsa Nacasch, and Eiran Harel, have nothing to disclose.
EDAT- 2024/02/08 00:42
MHDA- 2024/02/19 06:42
CRDT- 2024/02/07 18:11
PHST- 2023/09/03 00:00 [received]
PHST- 2023/12/26 00:00 [revised]
PHST- 2023/12/30 00:00 [accepted]
PHST- 2024/02/19 06:42 [medline]
PHST- 2024/02/08 00:42 [pubmed]
PHST- 2024/02/07 18:11 [entrez]
AID - S0165-1781(23)00661-3 [pii]
AID - 10.1016/j.psychres.2023.115711 [doi]
PST - ppublish
SO  - Psychiatry Res. 2024 Mar;333:115711. doi: 10.1016/j.psychres.2023.115711. Epub 
      2024 Jan 8.