Back to resultsfMRI Based EEG Neurofeedback as a Method of Enhancing Emotional Resilience Among Soldiers
Primary Purpose
Stress, Depression
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EEG neurofeedback
Sponsored by
About this trial
This is an interventional prevention trial for Stress focused on measuring stress and depression related symptoms
Eligibility Criteria
Inclusion Criteria:
- soldiers in preliminary combat training
Exclusion Criteria:
- known mental disorders or neuro-pathology
Sites / Locations
- Tel-Aviv Sourasky medical center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
NF group
Sham NF
A\T NF
Arm Description
This group will train modulation of the amygdala EEG fingerprint by EEG neurofeedback.
This group preform the same procedure as the NF group only reviving sham feedback
This group will train modulation of A\T ratio by EEG neurofeedback
Outcomes
Primary Outcome Measures
Change from baseline at Amygdala modulation ability
The test group will show a grater improvment from baseline in amygdala modulation abilities as measured by real time fMRI
Secondary Outcome Measures
Change from baseline in Emotion regulation ability
The test group will show grater improvement from baseline of emotion regulation abilities as measured by implicit and explicit test and by fMRI
Full Information
NCT ID
NCT02020265
First Posted
November 12, 2013
Last Updated
September 24, 2018
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02020265
Brief Title
fMRI Based EEG Neurofeedback as a Method of Enhancing Emotional Resilience Among Soldiers
Official Title
Longitudinal Study of the Effect of Neurofeedback Training on Soldiers Emotional Regulation Ability and Mental Resilience to Stress.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Depression
Keywords
stress and depression related symptoms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NF group
Arm Type
Experimental
Arm Description
This group will train modulation of the amygdala EEG fingerprint by EEG neurofeedback.
Arm Title
Sham NF
Arm Type
Sham Comparator
Arm Description
This group preform the same procedure as the NF group only reviving sham feedback
Arm Title
A\T NF
Arm Type
Active Comparator
Arm Description
This group will train modulation of A\T ratio by EEG neurofeedback
Intervention Type
Device
Intervention Name(s)
EEG neurofeedback
Primary Outcome Measure Information:
Title
Change from baseline at Amygdala modulation ability
Description
The test group will show a grater improvment from baseline in amygdala modulation abilities as measured by real time fMRI
Time Frame
At baseline and after 6 month of neurofeeback training.
Secondary Outcome Measure Information:
Title
Change from baseline in Emotion regulation ability
Description
The test group will show grater improvement from baseline of emotion regulation abilities as measured by implicit and explicit test and by fMRI
Time Frame
At baseline and after 6 month of neurofeedback training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
soldiers in preliminary combat training
Exclusion Criteria:
known mental disorders or neuro-pathology
Facility Information:
Facility Name
Tel-Aviv Sourasky medical center
City
Tel_Aviv
State/Province
Choose One
ZIP/Postal Code
6423906
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
fMRI Based EEG Neurofeedback as a Method of Enhancing Emotional Resilience Among Soldiers
We'll reach out to this number within 24 hrs