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

September 24, 2018 updated by: Tel-Aviv Sourasky Medical Center

Longitudinal Study of the Effect of Neurofeedback Training on Soldiers Emotional Regulation Ability and Mental Resilience to Stress.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Choose One
      • Tel_Aviv, Choose One, Israel, 6423906
        • Tel-Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • soldiers in preliminary combat training

Exclusion Criteria:

  • known mental disorders or neuro-pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and after 6 month of neurofeeback training.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and after 6 month of neurofeedback training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (ESTIMATE)

December 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0080-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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