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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02020265
• Other study ID #: 0080-13
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• soldiers in preliminary combat training

Exclusion Criteria:

• known mental disorders or neuro-pathology

Related Conditions & MeSH terms

• Depression
• Stress

Intervention

Device:
• EEG neurofeedback

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky medical center	Tel_Aviv	Choose One

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline and after 6 month of neurofeeback training.
Secondary	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	At baseline and after 6 month of neurofeedback training