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fMRI Based EEG Neurofeedback as a Method of Enhancing Emotional Resilience Among Soldiers

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ClinicalTrials.gov Identifier: NCT02020265
Recruitment Status : Unknown
Verified September 2018 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2013
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Study Description
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Brief Summary:
EEG protocols exist for reducing stress and improve PTSD symptoms (A/T EEG protocols, Peniston, 1993, Hammond, 2005) however; our innovative EEG-NF LMI approach intends to be more amygdala/stress specific and therefore more efficient. Three groups of soldiers, while in operational activity will go through 24 sessions of 3 different methods of EEG-NF; our newly developed NF via MLI, a standard procedure for NF via A/T and a placebo NF. Difference between the groups in regard to their emotion regulation capability will be tested by fMRI with regard to amygdala activation following EEG-NF LMI as well as two stress challenge tests.

Condition or disease Intervention/treatment Phase
Stress Depression Device: EEG neurofeedback Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Longitudinal Study of the Effect of Neurofeedback Training on Soldiers Emotional Regulation Ability and Mental Resilience to Stress.
Study Start Date : February 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NF group
This group will train modulation of the amygdala EEG fingerprint by EEG neurofeedback.
 Device: EEG neurofeedback
Sham Comparator: Sham NF
This group preform the same procedure as the NF group only reviving sham feedback
 Device: EEG neurofeedback
Active Comparator: A\T NF
This group will train modulation of A\T ratio by EEG neurofeedback
 Device: EEG neurofeedback


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline at Amygdala modulation ability [ Time Frame: At baseline and after 6 month of neurofeeback training. ]
    The test group will show a grater improvment from baseline in amygdala modulation abilities as measured by real time fMRI


Secondary Outcome Measures :
  1. Change from baseline in Emotion regulation ability [ Time Frame: At baseline and after 6 month of neurofeedback training ]
    The test group will show grater improvement from baseline of emotion regulation abilities as measured by implicit and explicit test and by fMRI


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • soldiers in preliminary combat training

Exclusion Criteria:

  • known mental disorders or neuro-pathology
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020265


Locations
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Israel
Tel-Aviv Sourasky medical center
Tel_Aviv, Choose One, Israel, 6423906
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02020265    
Other Study ID Numbers: 0080-13
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Keywords provided by Tel-Aviv Sourasky Medical Center:
stress and depression related symptoms
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms