NCT03585205

Brief Summary

The aim of the current research is to characterize the complex interaction between stress and cognitive workload. Furthermore, the investigators aim to create a functional magnetic resonance imaging (fMRI) inspired Electroencephalogram (EEG) brain-based bio-marker for cognitive load under stress. Secondary project 1 aim: The aim of this study is to characterize the link between sensorimotor network (SMN) within and between functional connectivity following the stress response and its association with physiological indices and self-report measures. Secondary project 2 aim: To elucidate temporal alterations of topological patterns (i.e., integration and segregation), the investigators seek to examine resting state fMRI data before and after a cognitive load task and an acute stress induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 23, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2018

Completed
Last Updated

August 22, 2022

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

May 22, 2018

Last Update Submit

August 17, 2022

Conditions

HealthyStress, Psychological

Keywords

Stress responseCognitive Load

Outcome Measures

Primary Outcomes (1)

  • Changes in behavioral and fMRI signal (BOLD)

    We anticipate to see changes in relevant brain networks via fMRI (measuring BOLD signal), and performance in a computerized task.

    1 day

Secondary Outcomes (8)

  • Changes in heart rate and HRV

    1 day

  • Changes in electrodermal activity

    1 day

  • Changes in Pupil Dilation

    1 day

  • Change in within functional connectivity of the sensorimotor network (bold fMRI signal)

    day 1

  • Change in functional connectivity metrics between sensorimotor network and other resting-state networks (default, salience, central executive) (bold fMRI signal)

    day 1

  • +3 more secondary outcomes

Study Arms (1)

cognitive load with/ without stress 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

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy male subjects who are eligible to participate in the study according to the eligibility criteria.

You may qualify if:

  • Healthy subjects - assessed via the health questionnaire attached as an addition to the protocol
  • Without any known neurological disease
  • Normal or corrected vision

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (4)

  • Hermans EJ, Henckens MJ, Joels M, Fernandez G. Dynamic adaptation of large-scale brain networks in response to acute stressors. Trends Neurosci. 2014 Jun;37(6):304-14. doi: 10.1016/j.tins.2014.03.006. Epub 2014 Apr 21.

    PMID: 24766931BACKGROUND

  • Vaisvaser S, Lin T, Admon R, Podlipsky I, Greenman Y, Stern N, Fruchter E, Wald I, Pine DS, Tarrasch R, Bar-Haim Y, Hendler T. Neural traces of stress: cortisol related sustained enhancement of amygdala-hippocampal functional connectivity. Front Hum Neurosci. 2013 Jul 5;7:313. doi: 10.3389/fnhum.2013.00313. eCollection 2013.

    PMID: 23847492BACKGROUND

  • Zhang Y, Dai Z, Hu J, Qin S, Yu R, Sun Y. Stress-induced changes in modular organizations of human brain functional networks. Neurobiol Stress. 2020 May 25;13:100231. doi: 10.1016/j.ynstr.2020.100231. eCollection 2020 Nov.

    PMID: 32490057BACKGROUND

  • Shine JM. Neuromodulatory Influences on Integration and Segregation in the Brain. Trends Cogn Sci. 2019 Jul;23(7):572-583. doi: 10.1016/j.tics.2019.04.002. Epub 2019 May 7.

    PMID: 31076192BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalFractures, Stress

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorFractures, BoneWounds and Injuries

Study Officials

  • Talma Hendler, MD, PhD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2018

First Posted

July 12, 2018

Study Start

October 23, 2017

Primary Completion

October 26, 2018

Study Completion

October 26, 2018

Last Updated

August 22, 2022

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)