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Neural Indications of Stress-Induced Mental Overload

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03585205
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Elbit Systems LTD
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
This aim of the current research is to characterize the complex interaction between stress and cognitive workload. Furthermore, we aim to create a functional magnetic resonance imaging (fMRI) inspired Electroencephalogram (EEG) brain-based bio-marker for cognitive load under stress.

Condition or disease Intervention/treatment Phase
Healthy Stress, Psychological Behavioral: Stress and cognitive load Induction Not Applicable

Detailed Description:

Research in the past years on stress and its influence on cognitive workload suggest that their relationship is not simply linear. On one hand, stress disrupts the processes of attention, memory and complicated decision making. While on the other hand, stress response allows the individual to recognize threats quickly, react accordingly, return the body to homeostasis, and prepare the organism to future challenges. However, it is still unclear why different individuals deal with cognitive workload under stress differently, and which brain mechanisms are underlying these processes.

In this current research the use of non invasive imaging techniques, such as EEG and fMRI, in addition to physiological measurements, such as heart rate, skin conductance, and eye movements, will allow an objective characterization of the individual's response to cognitive workload under stress.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neural Indications of Stress-Induced Mental Overload
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Experimental: Stress and cognitive load Induction
Participants will engage in a computerized task which induces cognitive load. Each participant will perform the task once under a stress condition and once under a neutral (non-stress) condition.
Behavioral: Stress and cognitive load Induction

Participants will engage in demanding cognitive load computerized tasks (such as N-back and Stroop tasks). They will engage in these tasks once in a non-stressful (neutral condition), and once in a stressful condition.

Psychological stress will be induced by the following methods:

  1. Limiting time for task completion
  2. Providing negative feedback on participants' performance in relation to others
  3. Presentation of sudden, loud sounds during task

Primary Outcome Measures :
  1. Behavioral and fMRI (BOLD) [ Time Frame: 1 day ]
    We anticipate to see changes in relevant brain networks via fMRI (measuring BOLD signal), and performance in a computerized task.

Secondary Outcome Measures :
  1. Changes in heart rate [ Time Frame: 1 day ]
    We expect stress to influence heart rate.

  2. Changes in electrodermal activity [ Time Frame: 1 day ]
    We expect both stress and cognitive load to influence the nor-adrenergic system. We expect to measure these effects via electrodermal activity.

  3. Changes in Pupil Dilation [ Time Frame: 1 day ]
    We expect both stress and load to influence the nor-adrenergic system. We expect to measure these effects via pupil dilation.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy subjects - assessed via the health questionnaire attached as an addition to the protocol
  • Without any known neurological disease
  • Normal or corrected vision
  • All subjects must apply the standard criteria for inclusion and exclusion for a medical MRI scan, according to the MRI safety screening questionnaire of the "Wohl" MRI institute of the Tel-Aviv Sourasky Medical Center.

Exclusion Criteria:

  • Neurological injury or disease
  • Claustrophobia
  • Unremoved metals (according to the MRI safety screening questionnaire)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03585205

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Contact: Ayam Greental, BSc +972528338672

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Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Talma Hendler, MD, Phd    +97236973953   
Contact: Ayam Greental, BSc    +972528338672   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Elbit Systems LTD
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Principal Investigator: Talma Hendler, MD, PhD Tel-Aviv Sourasky Medical Center
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Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT03585205    
Other Study ID Numbers: TASMC-18-TH-0407-17-TLV-CTIL
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tel-Aviv Sourasky Medical Center:
Stress response
Cognitive Load
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms