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Influence of Anxiety on Motor Learning, Memory and Motor Imagery Ability in Young Population

Primary Purpose

Anxiety

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

About this trial

This is an interventional basic science trial for Anxiety focused on measuring Anxiety, Motor Learning, Memory, Motor Imagery Ability

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.
  • Presence of State-Trait Anxiety Inventory scores corresponding to anxiety.

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 localised skin lesion or disease in the wrist area.

Sites / Locations

  • Claude Bernard University Lyon 1
  • University of AlcalΓ‘
  • Complutense University of Madrid
  • European University of Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Relaxation group

Control group

Arm Description

This group will perform the APMR

This group will perform the control intervention

Outcomes

Primary Outcome Measures

Manual task execution time measured in seconds by MATLAB
This is the time taken by the subject to execute a complete circumference. It shall be expressed in seconds (s). It shall be recorded and measured through MATLAB.
Manual task execution error measured in seconds by MATLAB.
It shall be the inaccuracy committed by the subject in the tracing of the reference circumference. The dots per inch (dpi) or pixels per inch (pix) recorded in each lap from lap No. 1 to lap No. 20 shall be considered. It shall be recorded and measured by MATLAB.
Execution Speed
This shall be the pixels drawn per unit of time. It shall be expressed in pixels per second (pix/s). It shall be recorded and measured by MATLAB.
Execution Accuracy
This refers to the dispersion of the set of values obtained from repeated measurements under the same conditions of the values of each of the laps. It shall be calculated as the ratio between the number of errors made divided by the execution speed from the previous data recorded in MATLAB. It shall be expressed in seconds: No. errors (pix) /V (pix/s) = (s).
Motor Imagery Ability_1
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 where higher scores represent greater motor imagery ability.
Motor Imagery Ability_2
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 where higher scores represent greater motor imagery ability.

Secondary Outcome Measures

Latency of the Electrodermal Activity
The skin conductance level and skin conductance responses shall be analyzed in terms of latency (s). It shall be recorded and measured by Empatica E4 wristband.
Rise time of the Electrodermal Activity
The skin conductance level and skin conductance responses shall be analyzed in terms of rise time (s). It shall be recorded and measured by Empatica E4 wristband.
Amplitude of the Electrodermal Activity
The skin conductance level and skin conductance responses shall be analyzed in terms of amplitude (ΞΌs). It shall be recorded and measured by Empatica E4 wristband.
Heart Rate
The Heart Rate (Hz) shall be analyzed. It shall be recorded and measured by Empatica E4 wristband through the analysis of the Blood Volumen Pulse.
Interbeat Intervals
The Interbeat Intervals (s) shall be analyzed. These Interbeat Intervals (IBIs) sequences will be provided by Empatica E4 wristband through the processing of the photoplethysmography signal.
Heart Rate Variability
The Heart Rate Variability (Hz) shall be analyzed. This measurement will be calculated from the Interbeat Intervals measured by Empatica E4 wristband through the Kubios software.

Full Information

First Posted
June 24, 2021
Last Updated
September 16, 2022
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
NCT04973956
Brief Title
Influence of Anxiety on Motor Learning, Memory and Motor Imagery Ability in Young Population
Official Title
Influencia de la Ansiedad en el Aprendizaje Motor de Una Tarea Manual Precisa, en la Memoria a Corto y Largo Plazo y en la Capacidad de ImaginaciΓ³n Motora
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Actual)
Study Completion Date
September 15, 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, 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 is essential. Several neural circuits have been identified that closely link the emotional system and the motion control system. Anxiety is defined by persistent and excessive worries that do not disappear even in the absence of the stressor. Anxiety has been found to produce inefficiencies in information processing, which can result in performance deficits, as well as self-reported anxiety has been linked to poorer working memory performance. In these stress and anxiety contexts, relaxation techniques have been widely used to reduce psychophysiological arousal levels. 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. How anxiety influence the way manual tasks are learned is still unknown. On the other hand, motor imagery (MI) is a cognitive process that is an important contributor to how movements are planned and executed. The use of MI has been recommended to improve movement learning and task execution. Knowing MI capacity is essential for creating effective and individualized MI programs. However, how anxiety can affect our motor imagery ability is still unknown. The main objective of this study is to determine and quantify the effects of anxiety in the learning of a precise manual task not previously trained on four parameters of fine motor control: time, error, speed, and accuracy. On the other hand, the aim is to determine if the ability of internal visual, external visual, and kinaesthetic imagery varies when the participants are subjected to anxiety. The investigators expect that participants with anxiety, to whom relaxation is induced, will show better motor performance on the fine motor task and better motor imagery ability. In contrast, the investigators expect that participants with anxiety, to whom relaxation is not induced, will show poorer motor performance on the fine motor task and poorer motor imagery ability.
Detailed Description
In order to meet the study objectives of determining and quantifying the effects of anxiety 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 AlcalΓ‘, 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 the participants 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, both groups will have anxiety measured with the State-Trait Anxiety Inventory (STAI) and then be randomized to either the relaxation intervention group or the control group. 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 the participants meet the criteria for inclusion in the study. At this point, the participants will be coded by assigning them a number, which will serve to identify each participant throughout the study. Participants will take the STAI, one of the most widely used instruments for the self-reported assessment of anxiety. Participants with scores indicative of anxiety will be included in the study. Included participants will be randomized through sealed envelopes stratified by gender to one of two experimental groups: relaxation or control. The participants will also take the Movement Imagery Questionnaire-3 (MIQ-3) to measure internal visual, external visual, kinaesthetic imagery ability, and the Edinburgh Handedness Inventory (EHI) to determine the participant's laterality. Depending on the group to which the participants have been assigned, the participants of the relaxation group will perform a relaxation intervention using the Abbreviated Progressive Muscle Relaxation technique (APMR). This intervention consists of a standardized 20 min session in which subjects are asked to sequentially tense and relax various muscle groups. To do so, participants will listen to an audio with relaxation instructions while seated in a reclining seat and dimmed lighting. Despite its brevity, this relaxation technique has been shown to be effective in reducing anxiety and has been shown to produce cognitive, behavioral, and physiological relaxation. On the other hand, participants in the control group will listen to a content-neutral audio for 20 minutes and will be seated in an un-reclined chair with normal lighting. After the relaxation or control intervention, 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 learning process and short-term memory of the task will be recorded. Afterward, there will be a 20-minute break during which participants will perform the MIQ-3 again. Finally, the task data will be collected to record the long-term memory 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 anxiety, relaxation, and motor imagery all produce effects on the 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 SPSS 25.0 statistical 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 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 time, error, speed, accuracy, electrodermal activity, heart rate variability, and kinaesthetic, internal visual, and external visual imagery will also be carried out. If the variable conforms to the normal, the mean, range, and standard deviation shall be calculated. If the variables do 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 (time, error, speed, and accuracy), and the differences between the first and last lap and between consecutive laps of the task in the same four parameters, both in the task performed in the short term and the long term. A further ANOVA analysis will take place for imagery ability, 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 learning, and its maintenance 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
Anxiety
Keywords
Anxiety, Motor Learning, Memory, Motor Imagery Ability

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 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
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation group
Arm Type
Active Comparator
Arm Description
This group will perform the APMR
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This group will perform the control intervention
Intervention Type
Other
Intervention Name(s)
Relaxation
Intervention Description
This group will perform the APMR. This intervention consists of a standardized 20 min session in which subjects are asked to sequentially tense and relax various muscle groups. To do so, participants will listen to an audio with relaxation instructions while seated in a reclining seat and dimmed lighting.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
This group will perform the control intervention, in which the participants will listen to a content-neutral audio for 20 minutes and will be seated in an un-reclined chair with normal lighting.
Primary Outcome Measure Information:
Title
Manual task execution time measured in seconds by MATLAB
Description
This is the time taken by the subject to execute a complete circumference. It shall be expressed in seconds (s). It shall be recorded and measured through MATLAB.
Time Frame
During the procedure
Title
Manual task execution error measured in seconds by MATLAB.
Description
It shall be the inaccuracy committed by the subject in the tracing of the reference circumference. The dots per inch (dpi) or pixels per inch (pix) recorded in each lap from lap No. 1 to lap No. 20 shall be considered. It shall be recorded and measured by MATLAB.
Time Frame
During the procedure
Title
Execution Speed
Description
This shall be the pixels drawn per unit of time. It shall be expressed in pixels per second (pix/s). It shall be recorded and measured by MATLAB.
Time Frame
During the procedure
Title
Execution Accuracy
Description
This refers to the dispersion of the set of values obtained from repeated measurements under the same conditions of the values of each of the laps. It shall be calculated as the ratio between the number of errors made divided by the execution speed from the previous data recorded in MATLAB. It shall be expressed in seconds: No. errors (pix) /V (pix/s) = (s).
Time Frame
During the procedure
Title
Motor Imagery Ability_1
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 where higher scores represent greater motor imagery ability.
Time Frame
During the procedure
Title
Motor Imagery Ability_2
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 where higher scores represent greater motor imagery ability.
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Latency of the Electrodermal Activity
Description
The skin conductance level and skin conductance responses shall be analyzed in terms of latency (s). It shall be recorded and measured by Empatica E4 wristband.
Time Frame
During the procedure
Title
Rise time of the Electrodermal Activity
Description
The skin conductance level and skin conductance responses shall be analyzed in terms of rise time (s). It shall be recorded and measured by Empatica E4 wristband.
Time Frame
During the procedure
Title
Amplitude of the Electrodermal Activity
Description
The skin conductance level and skin conductance responses shall be analyzed in terms of amplitude (ΞΌs). It shall be recorded and measured by Empatica E4 wristband.
Time Frame
During the procedure
Title
Heart Rate
Description
The Heart Rate (Hz) shall be analyzed. It shall be recorded and measured by Empatica E4 wristband through the analysis of the Blood Volumen Pulse.
Time Frame
During the procedure
Title
Interbeat Intervals
Description
The Interbeat Intervals (s) shall be analyzed. These Interbeat Intervals (IBIs) sequences will be provided by Empatica E4 wristband through the processing of the photoplethysmography signal.
Time Frame
During the procedure
Title
Heart Rate Variability
Description
The Heart Rate Variability (Hz) shall be analyzed. This measurement will be calculated from the Interbeat Intervals measured by Empatica E4 wristband through the Kubios software.
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. Presence of State-Trait Anxiety Inventory scores corresponding to anxiety. 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 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 NΓΊΓ±ez Nagy, PhD
Organizational Affiliation
University of Alcala
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sara F FernΓ‘ndez 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-RhΓ΄ne-Alpes
ZIP/Postal Code
69100
Country
France
Facility Name
University of AlcalΓ‘
City
AlcalΓ‘ De Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain
Facility Name
Complutense University of Madrid
City
Pozuelo De AlarcΓ³n
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
European University of Madrid
City
Villaviciosa De OdΓ³n
State/Province
Madrid
ZIP/Postal Code
28670
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16376016
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
Doumas M, Morsanyi K, Young WR. Cognitively and socially induced stress affects postural control. Exp Brain Res. 2018 Jan;236(1):305-314. doi: 10.1007/s00221-017-5128-8. Epub 2017 Nov 14.
Results Reference
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PubMed Identifier
30390828
Citation
MacIntyre TE, Madan CR, Moran AP, Collet C, Guillot A. Motor imagery, performance and motor rehabilitation. Prog Brain Res. 2018;240:141-159. doi: 10.1016/bs.pbr.2018.09.010. Epub 2018 Oct 24.
Results Reference
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PubMed Identifier
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Citation
Schuster C, Hilfiker R, Amft O, Scheidhauer A, Andrews B, Butler J, Kischka U, Ettlin T. Best practice for motor imagery: a systematic literature review on motor imagery training elements in five different disciplines. BMC Med. 2011 Jun 17;9:75. doi: 10.1186/1741-7015-9-75.
Results Reference
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PubMed Identifier
33310512
Citation
Trapero-Asenjo S, Gallego-Izquierdo T, Pecos-Martin D, Nunez-Nagy S. Translation, cultural adaptation, and validation of the Spanish version of the Movement Imagery Questionnaire-3 (MIQ-3). Musculoskelet Sci Pract. 2021 Feb;51:102313. doi: 10.1016/j.msksp.2020.102313. Epub 2020 Dec 9.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Influence of Anxiety on Motor Learning, Memory and Motor Imagery Ability in Young Population

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