NCT04912713

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
2 countries

4 active sites

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

First Submitted

Initial submission to the registry

May 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

May 26, 2021

Last Update Submit

June 21, 2023

Conditions

Keywords

Stress, PsychologicalLearningMemoryMovement

Outcome Measures

Primary Outcomes (6)

  • 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.

    During manual task performance in acquisition, short-term retrieval, and long-term retrieval.

  • 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.

    During manual task performance in acquisition, short-term retrieval, and long-term retrieval.

  • 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.

    During manual task performance in acquisition, short-term retrieval, and long-term retrieval.

  • 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.

    During manual task performance in acquisition, short-term retrieval, and long-term retrieval.

  • 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.

    Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress.

  • 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.

    Before induction of acute stress and in the resting period between short-term and long-term retrieval after induction of acute stress.

Secondary Outcomes (2)

  • Electrodermal Activity.

    During the procedure

  • Heart Rate Variability.

    During the procedure

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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.

Other: Stress group

Arm 2

ACTIVE COMPARATOR

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

Other: Control group

Interventions

This group will perform the MAST stress protocol

Arm 1

This group will perform the MAST control protocol

Arm 2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Claude Bernard University Lyon 1

Villeurbanne, Auvergne-Rhône-Alpes, 69100, France

Location

University of Alcala

Alcalá de Henares, Madrid, 28871, Spain

Location

Complutense University of Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

European University of Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

Location

Related Publications (8)

  • Coombes SA, Cauraugh JH, Janelle CM. Emotion and movement: activation of defensive circuitry alters the magnitude of a sustained muscle contraction. Neurosci Lett. 2006 Apr 3;396(3):192-6. doi: 10.1016/j.neulet.2005.11.048. Epub 2005 Dec 20.

    PMID: 16376016BACKGROUND
  • Ahn SN, Lee J. Effects of sensory awareness, imagery and observation on electroencephalography in adult with psychological stress. J Phys Ther Sci. 2019 Jan;31(1):17-19. doi: 10.1589/jpts.31.17. Epub 2019 Jan 10.

    PMID: 30774198BACKGROUND
  • 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.

    PMID: 30390828BACKGROUND
  • 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.

    PMID: 21682867BACKGROUND
  • 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.

    PMID: 33310512BACKGROUND
  • Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.

    PMID: 5146491BACKGROUND
  • Smeets T, Cornelisse S, Quaedflieg CW, Meyer T, Jelicic M, Merckelbach H. Introducing the Maastricht Acute Stress Test (MAST): a quick and non-invasive approach to elicit robust autonomic and glucocorticoid stress responses. Psychoneuroendocrinology. 2012 Dec;37(12):1998-2008. doi: 10.1016/j.psyneuen.2012.04.012. Epub 2012 May 18.

    PMID: 22608857BACKGROUND
  • Bali A, Jaggi AS. Clinical experimental stress studies: methods and assessment. Rev Neurosci. 2015;26(5):555-79. doi: 10.1515/revneuro-2015-0004.

    PMID: 26020552BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sara T Trapero Asenjo, Master

    University of Alcala

    PRINCIPAL INVESTIGATOR
  • Susana N Núñez Nagy, PhD

    University of Alcala

    STUDY DIRECTOR
  • Sara F Fernández Guinea, PhD

    Universidad Complutense de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD. Associate Professor of Physiotherapy

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 3, 2021

Study Start

June 14, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations