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Influence of Acute Stress on Motor Learning and Motor Imagery Ability in Young Population

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Stress group
Control group
Sponsored by
Susana Nunez Nagy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress, Psychological focused on measuring Stress, Psychological, Learning, Memory, Movement

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women between 18 and 35 years of age.
  • Normal or corrected vision specifying the method of correction.
  • Normal or corrected hearing specifying method of correction.
  • Unfamiliar with the assessment and uses of motor imagery.

Exclusion Criteria:

  • Subjects who have suffered fractures, dislocations, or traumatic processes in any segment of the non-dominant upper limb or fingers, wrist, or elbow of the dominant upper limb in the last 6 months.
  • Subjects with learning disabilities or problems in reading or writing.
  • Subjects with a history of any neurological disease, cardiovascular disease, myopathic disease, epileptic seizure, absence seizure, sleep apnoea, chronic fatigue syndrome, or fibromyalgia.
  • Taking any medication to suppress anxiety, to sleep, antidepressants, antihistamines, muscle relaxants, psychotropic, or other medications that interfere with the nervous system.
  • Intake of nervous system depressants or stimulants such as caffeine or theine in the last 8 hours.
  • Presence of State-Trait Anxiety Inventory scores corresponding to trait anxiety and state anxiety.
  • Presence of localised skin lesion or disease in the wrist area.

Sites / Locations

  • Claude Bernard University Lyon 1
  • University of Alcala
  • Complutense University of Madrid
  • European University of Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

This group will be randomly immersed in ice water (2°C temperature) for preset times and instructed to remove their hand if they cannot withstand these times. In total there will be 5 attempts with durations of 90, 60, 60, 60, 90 and 60 s respectively. Between dive attempts they will be instructed to put their arm on a towel and immediately do the arithmetic task of counting backwards from the number 2043 as quickly and accurately as they can. Each time they make a mistake in the mental task, they will be given negative feedback and must start again from the number 2043. The duration of the 4 arithmetic tasks (between each of the 5 immersion attempts) will be fixed at 45, 60, 90 and 45 s respectively.

This group will not be falsely recorded or evaluated. They will be randomly immersed in warm water (35-37°C temperature) for preset times and instructed to remove their hand if they cannot withstand these times. In total there will be 5 attempts with durations of 90, 60, 60, 60, 90 and 60 s respectively. Between dive attempts they will be instructed to put their arm on a towel and immediately do the simple counting task, in which they will have to count consecutively from 1 to 25 at their own pace. If they reach 25 they must start again and will never be given negative feedback. The duration of the 4 arithmetic tasks (between each of the 5 immersion attempts) will be fixed at 45, 60, 90 and 45 s respectively

Outcomes

Primary Outcome Measures

Trayectory error
It shall be the sum of the error between each of the points defining the path of the circumference. Pixels squared shall be considered as the unit of length measurement. To be recorded and measured with MATLAB. To be recorded and measured with MATLAB.
Timing error
It is the absolute value of the difference between the duration of 2 seconds requested from the subjects and the total time elapsed in the execution of the trajectory. It shall be expressed in seconds (s). It shall be recorded and measured using MATLAB.
Timing accuracy
The ability of the subject to learn the task at the requested rate of 2 seconds per lap. It shall be expressed in square pixels per second. It shall be recorded and measured by MATLAB.
Task accuracy
It shall be the ability of the subject to learn at any rate. It shall be expressed in pixels per second. It shall be recorded and measured by MATLAB.
Motor Imagery Capacity
This will be measured using the Movement Imagery Questionnaire-3, differentiating between the kinaesthetic, external visual and internal visual imagination subscales, each scored on a Likert scale from 1 to 7.
Discrepancy time
It will be the difference between the execution times and imagery of the MIQ-3 items. It will be measured with a stopwatch by the experimenter.

Secondary Outcome Measures

Electrodermal Activity.
The skin conductance level shall be analyzed in terms of tonic Electrodermal Activity. It shall be recorded and measured by Empatica E4 wristband.
Heart Rate Variability.
It will be analysed in the frequency domain, in its low and high frequency bands and in the ratio between them. It shall be recorded and measured by Empatica E4 wristband.

Full Information

First Posted
May 26, 2021
Last Updated
June 21, 2023
Sponsor
Susana Nunez Nagy
Collaborators
University of Alcala, Universidad Complutense de Madrid, European University of Madrid, Claude Bernard University
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1. Study Identification

Unique Protocol Identification Number
NCT04912713
Brief Title
Influence of Acute Stress on Motor Learning and Motor Imagery Ability in Young Population
Official Title
Influencia Del Estrés Agudo en el Aprendizaje Motor de Una Tarea Manual Precisa y en la Capacidad de Imaginación Motora
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susana Nunez Nagy
Collaborators
University of Alcala, Universidad Complutense de Madrid, European University of Madrid, Claude Bernard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In motor learning, it is essential to consider that movements are produced by the cooperation and combination of many brain structures and are influenced by the emotions to which individuals are subjected. Several neural circuits have been identified that closely link the emotional system and the motion control system. Stress is a physiological or psychological response to internal or external stressors. In principle, it has an adaptive role. However, the neuroendocrine and autonomic response generated by stress can affect cognitive processes such as memory. In addition, it has been shown to influence motor learning, especially the execution of skills in the early stages of learning. Understanding how movement, emotions and interactions are regulated is significant because of the large number of movements humans perform. Of these, manual tasks represent precise movements that require the integration of many elements by the nervous system to perform these tasks successfully. It is still unknown how acute stress influence the way manual tasks are learned. On the other hand, motor imagery (MI) is a cognitive process that is an important contributor to how movements are planned and executed. Its use has been recommended to improve movement learning and task execution. For an MI program to be effective and individualized, it is imperative to know this ability. However, it is also still unknown how acute stress can affect our motor imagery ability. The main objective of this study is to determine and quantify the effects of acute stress in the learning of a precise manual task not previously trained on four parameters of fine motor control: trajectory error, timing error, timing accuracy, and task accuracy. On the other hand, the aim is to determine if the capacity of internal visual, external visual, and kinesthetic imagery, and the temporal congruence between movement execution and imagery varies when we are subjected to acute stress. It is expected that non-anxious, non-stressed participants who are not induced with acute stress will show better motor performance on the fine motor task and better motor imagery ability and temporal congruence. In contrast, it is expected that participants without anxiety and stress who are induced with acute stress will show poorer motor performance on the fine motor task, and poorer motor imagery ability and temporal congruence.
Detailed Description
In order to meet the study objectives of determining and quantifying the effects of acute stress on learning a precise manual task and on motor imagery ability, this study will be conducted. The development of the study will take place in a conditioned room belonging to the University of Alcalá, the Complutense University of Madrid, the European University of Madrid, or Claude Bernard University Lyon 1. The study may also be carried out in other Spanish and international university centers, subject to the consent and permission of the respective centres. The study will be carried out by all national and international laws, regulations, and recommendations. The study design will be longitudinal, experimental, randomized, and double-blind, as specified in the present registry. The study population will be composed of participants who are undergraduate and postgraduate students at the university centers where the study will be carried out, from which they will be recruited. All participants included in the study must meet the study selection criteria and participate voluntarily after reading the information sheet and signing the informed consent form. The study will consist of two intervention groups, in which the Maastricht Acute Stress Test (MAST) protocol will be performed: one group will perform the acute stress induction protocol (MAST stress) and the other group will perform the no stress induction control protocol (MAST control). Each group will consist of a minimum number of 30 subjects to be able to study the desired effect. After each participant freely chooses to participate in the study, an initial questionnaire will be administered to ensure that they meet the criteria for inclusion in the study. At this point, they will be coded by assigning them a number, which will serve to identify each participant throughout the study. Participants will take the State-Trait Anxiety Inventory (STAI), one of the most widely used instruments for the self-reported assessment of anxiety and equivalent to a measure of stress, as it considers the amount of stressful stimulus. Thus, the two components of anxiety will be assessed: state anxiety and trait anxiety. Participants with scores indicative of state or trait anxiety will be excluded from the study, and those with scores indicating neither trait anxiety nor state anxiety will be included. Included participants will be randomized through sealed envelopes stratified by gender to one of two experimental groups: MAST stress, or MAST control. They will also take the Edinburgh Handedness Inventory (EHI) to determine the participant's laterality, and the Movement Imagery Questionnaire-3 (MIQ-3) to measure internal visual, external visual, kinaesthetic imagery capacity. At the same time of MIQ-3, the experimenter will record the execution and imagery times were recorded (for subsequent calculation of the time discrepancy between executed and imagery as a measure of temporal congruence between them). Depending on the group to which they have been assigned, they will perform the corresponding MAST protocol (stress or control). MAST stress is a non-invasive protocol to induce acute stress in the laboratory that combines components of psychological stress (evaluative social threat, uncontrollability, and unpredictability) and physical stress (sensation of pain through intense cold). The MAST control is a homologous protocol to the stress protocol but has no psychological or physical stressor components. After MAST protocol, participants will learn a precise manual task with the non-dominant hand. The task will consist of going over a 127 mm circumference on a graphics tablet at a rate of 2 seconds per lap, which will be set by a metronome using a wireless pen that will leave no trace of ink but will store the data in the MATLAB program via the graphics tablet. Thus, data from the acquisition and short-term retrieval of the task will be recorded. Afterward, there will be a 20-minute break during which participants will perform the MIQ-3 and the experimenter will record the execution and imagery times again. Finally, the task data will be collected to record the long-term retrieval of the manual task. In addition, during all experiments, electrodermal activity and heart rate variability will be recorded using the Empatica E4 physiological variable measurement wristband. This measurement of physiological variables will serve to confirm that a significant emotional effect has been generated and to test motor imagery processes since both acute stress and motor imagery produce activation of the autonomic nervous system. The analysis and processing of data from MATLAB version R2020b, and the Empatica E4 wristband will be performed using RStudio software and Kubios HRV software (for HRV analysis). First, appropriate statistical analyses will be performed to see if the data are distributed according to a standard curve through the Shapiro-Wilk test and to assess the influence of sex and age. Subsequently, the descriptive analysis of the relative and absolute frequencies for the qualitative variables of gender and age will be carried out, and their homogeneity will be tested using the Chi-square test. The descriptive analysis of the quantitative variables of trajectory error, timing error, timing accuracy, task accuracy, electrodermal activity, heart rate variability, kinaesthetic, internal visual, and external visual imagery, and discrpenacy times will also be carried out. If the variable conforms to the normal, the mean, range, and standard deviation shall be calculated. If it does not conform to the normal, non-parametric tests will be performed. Comparative analysis will be performed using mixed ANOVA to see the differences in the mean values respective to motor control (trajectory error, timing error, timing accuracy, and task accuracy). A further ANOVA analysis will take place for imagery ability and discrepancy times, comparing the results obtained at the two respective points during the experiment. The effect of learning between laps will be analyzed by repeated-measures ANOVA comparing each motor control measurement parameter with respect to the lapping factor. Electrodermal activity, and heart rate variability during the measurement of imagery ability, emotional state induction, manual task acquisition, and its retrieval in the short and long term will also be studied by repeated-measures ANOVA. For hypothesis testing, a significance level of 0.05 will be set.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Stress, Psychological, Learning, Memory, Movement

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
As participants complete the State-Trait Anxiety Inventory, and are found to be free of trait anxiety, and state anxiety, they will be randomised in parallel to one of the two intervention groups.
Masking
ParticipantOutcomes Assessor
Masking Description
The participant does not know what the other participants are doing, the researcher knows which study and group the subject is in, but only sets up the computerized presentations for each group and assigns folders within the computer that collects the data, thus avoiding a possible information bias, and finally, another researcher blind to the intervention will analyse the data to obtain the results.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
This group will be randomly immersed in ice water (2°C temperature) for preset times and instructed to remove their hand if they cannot withstand these times. In total there will be 5 attempts with durations of 90, 60, 60, 60, 90 and 60 s respectively. Between dive attempts they will be instructed to put their arm on a towel and immediately do the arithmetic task of counting backwards from the number 2043 as quickly and accurately as they can. Each time they make a mistake in the mental task, they will be given negative feedback and must start again from the number 2043. The duration of the 4 arithmetic tasks (between each of the 5 immersion attempts) will be fixed at 45, 60, 90 and 45 s respectively.
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
This group will not be falsely recorded or evaluated. They will be randomly immersed in warm water (35-37°C temperature) for preset times and instructed to remove their hand if they cannot withstand these times. In total there will be 5 attempts with durations of 90, 60, 60, 60, 90 and 60 s respectively. Between dive attempts they will be instructed to put their arm on a towel and immediately do the simple counting task, in which they will have to count consecutively from 1 to 25 at their own pace. If they reach 25 they must start again and will never be given negative feedback. The duration of the 4 arithmetic tasks (between each of the 5 immersion attempts) will be fixed at 45, 60, 90 and 45 s respectively
Intervention Type
Other
Intervention Name(s)
Stress group
Intervention Description
This group will perform the MAST stress protocol
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
This group will perform the MAST control protocol
Primary Outcome Measure Information:
Title
Trayectory error
Description
It shall be the sum of the error between each of the points defining the path of the circumference. Pixels squared shall be considered as the unit of length measurement. To be recorded and measured with MATLAB. To be recorded and measured with MATLAB.
Time Frame
During manual task performance in acquisition, short-term retrieval, and long-term retrieval.
Title
Timing error
Description
It is the absolute value of the difference between the duration of 2 seconds requested from the subjects and the total time elapsed in the execution of the trajectory. It shall be expressed in seconds (s). It shall be recorded and measured using MATLAB.
Time Frame
During manual task performance in acquisition, short-term retrieval, and long-term retrieval.
Title
Timing accuracy
Description
The ability of the subject to learn the task at the requested rate of 2 seconds per lap. It shall be expressed in square pixels per second. It shall be recorded and measured by MATLAB.
Time Frame
During manual task performance in acquisition, short-term retrieval, and long-term retrieval.
Title
Task accuracy
Description
It shall be the ability of the subject to learn at any rate. It shall be expressed in pixels per second. It shall be recorded and measured by MATLAB.
Time Frame
During manual task performance in acquisition, short-term retrieval, and long-term retrieval.
Title
Motor Imagery Capacity
Description
This will be measured using the Movement Imagery Questionnaire-3, differentiating between the kinaesthetic, external visual and internal visual imagination subscales, each scored on a Likert scale from 1 to 7.
Time Frame
Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress.
Title
Discrepancy time
Description
It will be the difference between the execution times and imagery of the MIQ-3 items. It will be measured with a stopwatch by the experimenter.
Time Frame
Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress.
Secondary Outcome Measure Information:
Title
Electrodermal Activity.
Description
The skin conductance level shall be analyzed in terms of tonic Electrodermal Activity. It shall be recorded and measured by Empatica E4 wristband.
Time Frame
During the procedure
Title
Heart Rate Variability.
Description
It will be analysed in the frequency domain, in its low and high frequency bands and in the ratio between them. It shall be recorded and measured by Empatica E4 wristband.
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women between 18 and 35 years of age. Normal or corrected vision specifying the method of correction. Normal or corrected hearing specifying method of correction. Unfamiliar with the assessment and uses of motor imagery. Exclusion Criteria: Subjects who have suffered fractures, dislocations, or traumatic processes in any segment of the non-dominant upper limb or fingers, wrist, or elbow of the dominant upper limb in the last 6 months. Subjects with learning disabilities or problems in reading or writing. Subjects with a history of any neurological disease, cardiovascular disease, myopathic disease, epileptic seizure, absence seizure, sleep apnoea, chronic fatigue syndrome, or fibromyalgia. Taking any medication to suppress anxiety, to sleep, antidepressants, antihistamines, muscle relaxants, psychotropic, or other medications that interfere with the nervous system. Intake of nervous system depressants or stimulants such as caffeine or theine in the last 8 hours. Presence of State-Trait Anxiety Inventory scores corresponding to trait anxiety and state anxiety. Presence of localised skin lesion or disease in the wrist area.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara T Trapero Asenjo, Master
Organizational Affiliation
University of Alcala
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susana N Núñez Nagy, PhD
Organizational Affiliation
University of Alcala
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sara F Fernández Guinea, PhD
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Claude Bernard University Lyon 1
City
Villeurbanne
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
69100
Country
France
Facility Name
University of Alcala
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain
Facility Name
Complutense University of Madrid
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
European University of Madrid
City
Villaviciosa De Odón
State/Province
Madrid
ZIP/Postal Code
28670
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Influence of Acute Stress on Motor Learning and Motor Imagery Ability in Young Population

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