- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02020265
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
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
-
-
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.
|
|
SHAM_COMPARATOR: Sham NF
This group preform the same procedure as the NF group only reviving sham feedback
|
|
ACTIVE_COMPARATOR: A\T NF
This group will train modulation of A\T ratio by 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
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
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.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Lawson Health Research InstituteTerminated
Clinical Trials on EEG neurofeedback
-
Radboud University Medical CenterCompleted
-
University of North Carolina, WilmingtonCompleted
-
Tel-Aviv Sourasky Medical CenterUnknownDepression | Premenstrual Dysphoric Disorder (PMDD)Israel
-
Steinn SteingrimssonRecruiting
-
University of ConnecticutUnknown
-
Centre Hospitalier Universitaire de BesanconPlateforme NeuraxessRecruitingEmotional Regulation | Risk-TakingFrance
-
NYU Langone HealthCompletedAttention Deficit Hyper ActivityUnited States
-
Rennes University HospitalUnknown
-
Wyss Center for Bio and NeuroengineeringEcole Polytechnique Fédérale de LausanneCompleted
-
L. Eugene ArnoldNational Institute of Mental Health (NIMH); Brain Resource CenterCompletedAttention Deficit Hyperactivity DisorderUnited States