Neurofeedback Prevention For Early Stress Related Adversity

NCT02477722 | Unknown

• 1 other identifier: 0616-14-TLV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Exposure to life threatening, traumatic and stress inducing events in general is an inevitable part of military combat service . Among individuals exposed to a traumatic event, approximately 85-90 % will develop a stress response from which they will recover without need for any medical intervention whatsoever. However, roughly 10-15 % will continue to suffer from post-traumatic symptoms along with depression or anxiety disorders1, . The prominent symptoms of post - traumatic stress disorder (PTSD), consists of reliving the event via invasive and painful memories that include: images, thoughts or feelings, night terrors, and extreme emotional distress that arise when exposure to external or internal cues similar to or symbolizing aspects of the traumatic event. Following this distress, behavioral avoidance of situations that trigger unpleasant memories may develop. Such mental stress may lead to avoidance of social situations and hinder normal daily functioning in a variety of contexts2. The question arises as to what distinguishes between those who are exposed to a traumatic event and recover spontaneously and those who fail to resume daily life and develop PTSD. Attempts to find personality and environmental risk factors for the development of PTSD have yet to yield any unequivocal conclusions. This has lead the scientific community to look for neuro-physical risk factors as well . Furthermore, evidence that early diagnosis and treatment of the disorder helps reduce the severity of post-trauma symptoms -stresses the need for the accurate localization of neurological risk factors and new immediate and/or preventative interventions. The aim of the present project is to develop a brain oriented training method for early preventive interventions of PTSD.

Conditions

Feedback, Psychological; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• Change in Psychiatric Evaluation of PTSD Symptoms

  Days 1-7 and 6 months after training

Secondary Outcomes (7)

• fMRI Scan as a measure of change in amygdala reactivity

  Days 1-7 and 6 months after training

• Change in Emotion Regulation Questionnaire (ERQ) as a measure of change in cognitive coping strategies

  Days 1-7 and 6 months after training

• State/Trait Anxiety Inventory (STAI) as a measure of change in state & trait anxiety

  Days 1-7 and 6 months after training

• Beck Depression Inventory (BDI-II) as a measure of change in clinical depression

  Days 1-7 and 6 months after training

• Debriefing interview questionnaire as a measure of general experience of the process and adverse effects

  6 months after training

Study Arms (2)

EFP-NF

EXPERIMENTAL

Subjects are asked to change their brain activity in response to feedback they receive from the brain itself, mediated via various visual or auditory stimuli.

Other: EFP-NF

Sham-NF

SHAM COMPARATOR

Placebo

Other: Sham

Interventions

EFP-NF OTHER

EFP-NF

Sham OTHER

Sham-NF

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Whol Institute for Advanced Imaging, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (9)

• Caria A, Veit R, Sitaram R, Lotze M, Weiskopf N, Grodd W, Birbaumer N. Regulation of anterior insular cortex activity using real-time fMRI. Neuroimage. 2007 Apr 15;35(3):1238-46. doi: 10.1016/j.neuroimage.2007.01.018. Epub 2007 Jan 31.

  PMID: 17336094 BACKGROUND

• deCharms RC, Christoff K, Glover GH, Pauly JM, Whitfield S, Gabrieli JD. Learned regulation of spatially localized brain activation using real-time fMRI. Neuroimage. 2004 Jan;21(1):436-43. doi: 10.1016/j.neuroimage.2003.08.041.

  PMID: 14741680 BACKGROUND

• deCharms RC, Maeda F, Glover GH, Ludlow D, Pauly JM, Soneji D, Gabrieli JD, Mackey SC. Control over brain activation and pain learned by using real-time functional MRI. Proc Natl Acad Sci U S A. 2005 Dec 20;102(51):18626-31. doi: 10.1073/pnas.0505210102. Epub 2005 Dec 13.

  PMID: 16352728 BACKGROUND

• Linden, D. & Lancaster, T. (2011). Functional magnetic resonance imaging (fMRI) - based neurofeedback as a new treatment tool for depression. European Psychiatry, 26(1), 937-946.

  BACKGROUND

• Johnston SJ, Boehm SG, Healy D, Goebel R, Linden DE. Neurofeedback: A promising tool for the self-regulation of emotion networks. Neuroimage. 2010 Jan 1;49(1):1066-72. doi: 10.1016/j.neuroimage.2009.07.056. Epub 2009 Jul 29.

  PMID: 19646532 BACKGROUND

• Meir-Hasson Y, Kinreich S, Podlipsky I, Hendler T, Intrator N. An EEG Finger-Print of fMRI deep regional activation. Neuroimage. 2014 Nov 15;102 Pt 1:128-41. doi: 10.1016/j.neuroimage.2013.11.004. Epub 2013 Nov 15.

  PMID: 24246494 BACKGROUND

• Cavazza, M. et al., Towards emotional regulation through neurofeedback, in Proceedings of the 5th Augmented Human International Conference (ACM, March, 2014), p. 42.

  BACKGROUND

• Meir-Hasson, Y. et al., A Common amygdala EEG Finger-Print for self-regulation training, (Submitted). Journal of Neuroscience Methods.

  BACKGROUND

• Keynan, J.N., et al.,. Reaching the unreachable: online-monitoring and guided regulation of amygdala activity using spatially enriched EEG. (In Preparation).

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Talma Hendler, M.D, Ph.D

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: June 23, 2015
• Study Start: April 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: June 1, 2019
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

IL (1)