- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07781670
Neurophysiological and Autonomic Responses to Acute Physical and Emotional Stress: An EEG Study
Electrophysiological, Autonomic, and Psychological Responses to Acute Physical and Emotional Stress: A Within-Subject Experimental EEG Study
This study aims to investigate neurophysiological, autonomic, and subjective responses to different acute physical and emotional stress-inducing conditions using a within-subject repeated-measures design.
Participants will complete four experimental conditions: a resting-state baseline, a Cold Pressor Test, a negative autobiographical memory recall task, and an affective picture-viewing task using stimuli selected from the Nencki Affective Picture System (NAPS). The order of the experimental stress conditions will be randomized or counterbalanced to minimize potential order and carry-over effects.
Electroencephalographic (EEG) and autonomic activity will be recorded throughout the experimental session. Autonomic measures will include heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), and skin conductance responses (SCR). Subjective levels of stress, anxiety, and pain will be assessed using visual analogue scales (VAS).
Participants will also complete validated psychological measures assessing resilience, perceived stress, and state and trait anxiety, together with the Tower of London task as a behavioral measure of executive planning.
The primary objective is to characterize the modulation of EEG alpha-band activity during acute physical stress, with the main comparison focusing on the Cold Pressor Test relative to resting-state baseline. Secondary and exploratory objectives include comparing cortical, autonomic, and subjective responses across experimental conditions and investigating whether individual psychological characteristics and executive functioning are associated with differences in psychophysiological stress responses.
Study Overview
Status
Conditions
Detailed Description
The study will employ a within-subject repeated-measures design to investigate neurophysiological, autonomic, subjective, and cognitive responses to different acute physical and emotional stress-inducing conditions.
Each participant will complete four experimental conditions within a single experimental session: (1) a resting-state baseline, (2) a Cold Pressor Test, (3) a negative autobiographical memory recall task, and (4) an affective picture-viewing task using stimuli selected from the Nencki Affective Picture System (NAPS). The order of the experimental stress conditions will be randomized or counterbalanced across participants to reduce systematic order, habituation, fatigue, and carry-over effects. Appropriate recovery periods will be introduced between conditions.
During the resting-state baseline, participants will remain seated and relaxed with their eyes closed for four minutes. This condition will provide a reference measure of spontaneous cortical and autonomic activity.
During the Cold Pressor Test, participants will immerse one hand in an ice-water bath and will be instructed to maintain the immersion for as long as tolerable, up to a maximum of three minutes. Participants will be allowed to withdraw their hand at any time if the stimulation becomes intolerable. Actual immersion duration will be recorded as an index of pain tolerance.
During the negative autobiographical memory recall condition, participants will be instructed to select a personally painful or distressing autobiographical memory and focus on its emotional and experiential aspects for three minutes while seated with their eyes closed. No specific autobiographical event will be suggested by the researcher.
During the affective picture-viewing condition, participants will view negative and neutral images selected from the NAPS. Each trial will consist of a fixation period followed by presentation of an affective or neutral image. The presentation order will be randomized.
Electroencephalographic (EEG) and autonomic activity will be recorded throughout the experimental session. Autonomic measures will include heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), and skin conductance responses (SCR). Particular attention will be given to EEG alpha-band activity over frontal, parietal, and frontoparietal regions.
Subjective ratings of stress, anxiety, and pain will be obtained using visual analogue scales (VAS) following the relevant experimental conditions. Participants will also complete validated psychological questionnaires assessing resilience, perceived stress using the 10-item Perceived Stress Scale (PSS-10), and state and trait anxiety using the State-Trait Anxiety Inventory (STAI-Y).
Executive functioning will be assessed using the 12-problem version of the Tower of London task. The task will be administered after the resting-state assessment and will provide a behavioral measure of executive planning and related higher-order cognitive processes.
The primary objective of the study is to characterize the modulation of EEG alpha-band activity associated with acute physical stress, with the main comparison focusing on the Cold Pressor Test relative to the resting-state baseline.
Secondary objectives include characterizing autonomic responses, including HRV, EDA, and SCR, and subjective stress, anxiety, and pain responses across the experimental conditions. Additional analyses will examine EEG activity across the different experimental conditions.
Exploratory analyses will investigate whether individual psychological characteristics, executive functioning, and pain tolerance are associated with differences in cortical, autonomic, and subjective responses to acute stress. Multivariate exploratory analyses may also be conducted to integrate EEG, autonomic, cognitive, and psychological measures and characterize individual patterns of psychophysiological stress response.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Teresa Fazia, PhD
- Phone Number: +390382987188
- Email: teresa.fazia@unipv.it
Study Locations
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Lombardy
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Pavia, Lombardy, Italy, 27100
- Recruiting
- University of Pavia
-
Contact:
- Teresa Fazia
- Phone Number: +390382987188
- Email: teresa.fazia@unipv.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years.
- Ability to understand the study procedures and provide written informed consent.
- Sufficient knowledge of the Italian language to understand study instructions and complete the psychological assessments.
Exclusion Criteria:
- History of major neurological disorders or other medical conditions that could significantly affect EEG or autonomic measurements.
- Current severe psychiatric disorder that could interfere with participation in the experimental procedures.
- Cardiovascular conditions for which exposure to the Cold Pressor Test may be contraindicated.
- Medical conditions affecting peripheral circulation or sensitivity of the upper limbs that could interfere with or increase the risk associated with the Cold Pressor Test.
- Current use of medications that may substantially affect autonomic or central nervous system activity, when considered clinically relevant to the study procedures.
- Presence of wounds, injuries, or other conditions affecting the hand that would prevent safe completion of the Cold Pressor Test.
- Inability to complete the experimental procedures or provide valid informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Stress Conditions
Participants will complete a single experimental session including a resting-state baseline, a Cold Pressor Test, a negative autobiographical memory recall task, and an affective picture-viewing task.
EEG and autonomic activity will be continuously recorded throughout the experimental session.
The order of the experimental stress conditions will be randomized or counterbalanced across participants, with appropriate recovery periods between conditions.
|
Participants will immerse one hand in an ice-water bath and will be instructed to maintain the immersion for as long as tolerable, up to a maximum of three minutes.
Participants may withdraw their hand at any time if the stimulation becomes intolerable.
The actual duration of hand immersion will be recorded as an index of pain tolerance.
EEG and autonomic activity will be continuously recorded during the task.
Participants will be instructed to select a personally painful or distressing autobiographical memory and focus on its emotional and experiential aspects for three minutes while seated with their eyes closed.
No specific autobiographical event will be suggested by the researcher.
EEG and autonomic activity will be continuously recorded during the task.
Participants will view negative and neutral images selected from the Nencki Affective Picture System (NAPS).
Each trial will consist of a 10-second fixation period followed by a 30-second image presentation.
Images will be presented in randomized order while EEG and autonomic activity are continuously recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in EEG alpha-band activity during the Cold Pressor Test compared with resting-state baseline
Time Frame: Day 1. During the single experimental session: resting-state baseline (4 minutes) and Cold Pressor Test (up to 3 minutes).
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EEG alpha-band activity will be quantified from predefined scalp regions, with particular attention to frontal, parietal, and frontoparietal regions.
The primary outcome will be the within-participant change in alpha-band EEG activity during the Cold Pressor Test relative to the resting-state baseline.
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Day 1. During the single experimental session: resting-state baseline (4 minutes) and Cold Pressor Test (up to 3 minutes).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG alpha/theta ratio across experimental conditions
Time Frame: Day 1. During the single experimental session.
|
The EEG alpha/theta power ratio will be calculated as the ratio between alpha-band and theta-band EEG power in predefined scalp regions and compared within participants across the resting-state baseline, Cold Pressor Test, negative autobiographical memory recall, and affective picture-viewing conditions.
The alpha/theta ratio is a dimensionless measure.
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Day 1. During the single experimental session.
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Heart rate variability across experimental conditions
Time Frame: Day 1. During the single experimental session
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Heart rate variability (HRV) will be derived from cardiac recordings and compared across the resting-state baseline, Cold Pressor Test, negative autobiographical memory recall, and affective picture-viewing conditions.
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Day 1. During the single experimental session
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Electrodermal activity across experimental conditions
Time Frame: Day 1. During the single experimental session
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Electrodermal activity (EDA) will be continuously recorded throughout the experimental session as an index of sympathetic autonomic activation.
EDA will be compared within participants across the resting-state baseline, Cold Pressor Test, negative autobiographical memory recall, and affective picture-viewing conditions.
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Day 1. During the single experimental session
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Skin conductance responses across experimental conditions
Time Frame: Day 1. During the single experimental session
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Skin conductance responses (SCR) will be derived from electrodermal recordings obtained continuously during the experimental session.
The number and frequency of measurable SCRs will be quantified and compared within participants across the resting-state baseline, Cold Pressor Test, negative autobiographical memory recall, and affective picture-viewing conditions.
Higher values indicate a greater frequency of phasic electrodermal responses.
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Day 1. During the single experimental session
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Subjective perceived stress across experimental conditions
Time Frame: Day 1. Immediately following the relevant experimental conditions during the single experimental session.
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Subjective perceived stress will be assessed using a Visual Analogue Scale for Stress (VAS-Stress), ranging from 0 to 100, where 0 indicates no perceived stress and 100 indicates the highest level of perceived stress imaginable.
Higher scores indicate greater perceived stress.
VAS-Stress scores will be compared within participants across the relevant experimental conditions.
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Day 1. Immediately following the relevant experimental conditions during the single experimental session.
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Subjective anxiety across experimental conditions
Time Frame: Day 1. Immediately following the relevant experimental conditions during the single experimental session.
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Subjective anxiety will be assessed using a Visual Analogue Scale for Anxiety (VAS-Anxiety), ranging from 0 to 100, where 0 indicates no anxiety and 100 indicates the highest level of anxiety imaginable.
Higher scores indicate greater subjective anxiety.
VAS-Anxiety scores will be compared within participants across the relevant experimental conditions.
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Day 1. Immediately following the relevant experimental conditions during the single experimental session.
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Subjective pain intensity following the Cold Pressor Test
Time Frame: Day 1. Immediately following the Cold Pressor Test during the single experimental session.
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Subjective pain intensity will be assessed using a Visual Analogue Scale for Pain (VAS-Pain), ranging from 0 to 100, where 0 indicates no pain and 100 indicates the worst pain imaginable.
Higher scores indicate greater perceived pain intensity.
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Day 1. Immediately following the Cold Pressor Test during the single experimental session.
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Pain tolerance during the Cold Pressor Test
Time Frame: Day 1. During the Cold Pressor Test within the single experimental session.
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Pain tolerance will be assessed as the duration of hand immersion in the ice-water bath, measured in seconds, ranging from 0 to 180 seconds.
Higher values indicate greater pain tolerance.
Participants may withdraw their hand at any time, and the Cold Pressor Test will be terminated after a maximum of 180 seconds.
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Day 1. During the Cold Pressor Test within the single experimental session.
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Percentage of stimuli eliciting a skin conductance response during affective picture viewing
Time Frame: Day 1. During the affective picture-viewing condition within the single experimental session.
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The percentage of affective picture-viewing trials eliciting a measurable skin conductance response (SCR) will be calculated as the number of trials associated with a measurable SCR divided by the total number of evaluable trials, multiplied by 100.
Scores range from 0% to 100%, with higher values indicating a greater proportion of stimuli eliciting a measurable electrodermal response.
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Day 1. During the affective picture-viewing condition within the single experimental session.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EEG_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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