NCT04911439

Brief Summary

In motor learning 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. Arousal is associated with many emotional responses and has effects on the nervous and motor system. In line with the "Inverted 'U' Hypothesis", all levels of both high and low arousal do not allow optimal task performance, yet moderate levels lead to excellent performance. Arousal also plays a vital role in movement learning, where a critical element is memory. There is evidence that a minimum level of arousal is required to encode or record information and that that moderate levels of arousal improve memory. 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 different levels of arousal 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. For an effective and individualize MI program is imperative to know this capacity. However, how different levels of arousal can affect our motor imagery ability is also still unknown. The main objective of this study is to determine and quantify the effects of arousal levels 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 participants are subjected to different levels of arousal. Researches expect that non-anxious, non-stressed participants who are shown images that elicit an optimal level of arousal will show better motor performance on the fine motor task and better motor imagery ability. In contrast, researches expect that participants without anxiety and stress who are shown pictures that elicit a sub-optimal level of arousal will show poorer motor performance on the fine motor task and poorer motor imagery ability.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

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 24, 2021

Completed
10 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

May 24, 2021

Last Update Submit

March 18, 2022

Conditions

Keywords

ArousalMotor LearningMemoryMotor Imagery Ability

Outcome Measures

Primary Outcomes (5)

  • 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.

    During procedure

  • 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.

    During procedure

  • 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.

    During procedure

  • 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).

    During procedure

  • Motor Imagery Ability

    This will be measured using the Movement Imagery Questionnaire-3, differentiating between the kinaesthetic, external visual and internal visual imagination subscales. Each subscale has 4 items and each item can be scored on a Likert scale from 1 to 7 points, where 1=very difficult to see/feel the movement and 7=very easy to see/feel the movement. Therefore, higher scores represent greater imaginative ability and each subscale can have a minimum of 4 points and a maximum of 28 points.

    Two points: Before procedure, resting period during procedure

Secondary Outcomes (6)

  • Latency of the Electrodermal Activity

    During procedure

  • Rise time of the Electrodermal Activity

    During procedure

  • Amplitude of the Electrodermal Activity

    During procedure

  • Heart Rate

    During procedure

  • Interbeat Intervals

    During procedure

  • +1 more secondary outcomes

Study Arms (3)

Low Arousal

ACTIVE COMPARATOR

This group will see 25 affective images of the International Affective Picture System with low arousal level during 8-12 randomly seconds each one at time and with randomly rest of 8-12 seconds between images.

Other: Low Arousal

Medium Arousal

ACTIVE COMPARATOR

This group will see 25 affective images of the International Affective Picture System with medium arousal level during 8-12 randomly seconds each one at time and with randomly rest of 8-12 seconds between images.

Other: Medium arousal

High Arousal

ACTIVE COMPARATOR

This group will see 25 affective images of the International Affective Picture System with high arousal level during 8-12 randomly seconds each one at time and with randomly rest of 8-12 seconds between images.

Other: High arousal

Interventions

This group will see affective images of the International Affective Picture System with low arousal level

Low Arousal

This group will see affective images of the International Affective Picture System with medium arousal level

Medium Arousal

This group will see affective images of the International Affective Picture System with high arousal level

High Arousal

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 (7)

  • Stins JF, Beek PJ. Effects of affective picture viewing on postural control. BMC Neurosci. 2007 Oct 4;8:83. doi: 10.1186/1471-2202-8-83.

    PMID: 17916245BACKGROUND
  • 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
  • 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
  • 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

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 three intervention groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD. Associate Professor of Physiotherapy

Study Record Dates

First Submitted

May 24, 2021

First Posted

June 3, 2021

Study Start

June 14, 2021

Primary Completion

March 18, 2022

Study Completion

March 18, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations