NCT05363852

Brief Summary

A sample of 101 individuals will be used for this purpose, where each of them will be exposed to 145 different stimuli. Comparison of their physiological responses to stimuli (cerebral blood flow, electrical activity of the brain, heart rate variability, and skin conductance response) and the perception of the stimuli measured by the questionnaire and CA method will make it possible to identify the method that provides more accurate information on the real perception of the stimuli. These findings may have important consequences for the use of the questionnaire and the CA method to measure different psychological concepts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

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 20, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

April 18, 2022

Last Update Submit

February 23, 2025

Conditions

Keywords

Functional magnetic resonanceEmotional responseColor association method

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow

    Changes in cerebral blood flow measured using functional magnetic resonance after applied stimuli

    10 seconds

Secondary Outcomes (3)

  • Brain electrical activity

    10 seconds

  • Heart rate variability

    10 seconds

  • Skin conductance response

    10 seconds

Study Arms (1)

Emotional reaction

EXPERIMENTAL

Physiological responses (cerebral blood flow, brain electrical activity, heart rate variability, and skin conduct-ance response) to visual word and picture stimuli

Diagnostic Test: Standard set of visual word and picture stimuli

Interventions

Set ot 145 stimuli: 115 words (three sets of 35 words with positive, neutral, and negative content) and 30 pictures (two sets of 15 photos with positive and negative content).

Emotional reaction

Eligibility Criteria

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

You may qualify if:

  • healthy volunteer
  • aged 18-64 years
  • participation in oter study within 6 weeks
  • signed Informed consent

You may not qualify if:

  • contraindication to magnetic resonance imaging examination
  • pregnancy or potential pregnancy
  • history of a head injury, seizures (photophobia, epilepsy), dizziness
  • significant neurological or psychiatric disease, or other clinical difficulties (depression, anxiety, panic attacks, claustrophobia, AD(H)D, stroke, cardiac prob-lems, etc.)
  • chronic medication, including hypnotics, analgesics, or other substances that affect brain function (antihistamines, medicines to reduce mucosal swelling, etc.)
  • brain pathology detected on brain magnetic resonance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, University of Ostrava

Ostrava, 70300, Czechia

Location

Study Officials

  • Jiří Balcar, Ass Prof

    Vysoka skola banska: Technicka univerzita Ostrava

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Healthy volunteers were included to the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

May 6, 2022

Study Start

October 20, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Data will be available in Mendeley

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data will become available when the results will be submitted for publication fo 5 years.
Access Criteria
upon request to author

Locations