NCT02020265

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

5.8 years

First QC Date

November 12, 2013

Last Update Submit

September 24, 2018

Conditions

StressDepression

Keywords

stress and depression related symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline in Emotion regulation ability

    At baseline and after 6 month of neurofeedback training

Study Arms (3)

NF group

EXPERIMENTAL

This group will train modulation of the amygdala EEG fingerprint by EEG neurofeedback.

Device: EEG neurofeedback

Sham NF

SHAM COMPARATOR

This group preform the same procedure as the NF group only reviving sham feedback

Device: EEG neurofeedback

A\T NF

ACTIVE COMPARATOR

This group will train modulation of A\\T ratio by EEG neurofeedback

Device: EEG neurofeedback

Interventions

EEG neurofeedbackDEVICE
A\T NFNF groupSham NF

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • soldiers in preliminary combat training

You may not qualify if:

  • known mental disorders or neuro-pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky medical center

Tel_Aviv, Choose One, 6423906, Israel

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

December 24, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

IL(1)