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

NCT ID: NCT02020265

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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NF group

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

Group Type EXPERIMENTAL

EEG neurofeedback

Intervention Type DEVICE

Sham NF

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

Group Type SHAM_COMPARATOR

EEG neurofeedback

Intervention Type DEVICE

A\T NF

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

Group Type ACTIVE_COMPARATOR

EEG neurofeedback

Intervention Type DEVICE

Interventions

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EEG neurofeedback

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* soldiers in preliminary combat training

Exclusion Criteria

* known mental disorders or neuro-pathology
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel-Aviv Sourasky medical center

Tel_Aviv, Choose One, Israel

Site Status

Countries

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Israel

Other Identifiers

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0080-13

Identifier Type: -

Identifier Source: org_study_id

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