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Complex Motor Learning With Motor Imaginary

Primary Purpose

Learning Disturbance

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Motor imaginary
Non Motor imaginary
tDCS
tDCS sham
Neurofeedback
Neurofeedback sham
Sponsored by
Centro Universitario La Salle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Learning Disturbance

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18 and 29 years old
  • Asymptomatic

Exclusion Criteria:

  • Subjects with pain
  • In medical treatment
  • Diagnosed of any disease

Sites / Locations

  • Centro Superior de Estudios Universitarios La SalleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Motor imaginary

Non Motor imaginary

tDCS

tDCS sham

Neurofeedback

Neurofeedback sham

Arm Description

Intervention with Motor imaginary with video

Intervention with Rest without motor imaginary

tDCS stimulation during 20 minutes in the motor cortex.

tDCS stimulation during 30 seconds in the motor cortex and then 19 minutes and 30 seconds without any stimulation.

EEG monitoring in real time with positive feedback in the computer screen when participants motor cortex is activated.

EEG monitoring in real time with randomized feedback in the computer screen despite the motor cortex activation.

Outcomes

Primary Outcome Measures

Time
Minutes of time when the task is learned

Secondary Outcome Measures

Full Information

First Posted
November 24, 2016
Last Updated
July 30, 2018
Sponsor
Centro Universitario La Salle
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1. Study Identification

Unique Protocol Identification Number
NCT02999516
Brief Title
Complex Motor Learning With Motor Imaginary
Official Title
Complex Motor Learning With Motor Imaginary
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario La Salle

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Subjects participate in a motor learning training with a special bicycle. The experimental group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest where they use motor imaginary. The control group proceed equal except for the motor imaginary intervention.
Detailed Description
Subjects participate in a motor learning training with a special bicycle. The experimental group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest where they use motor imaginary. The control group proceed equal except for the motor imaginary intervention. Participants will be controlled for vestibular system previous participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disturbance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor imaginary
Arm Type
Experimental
Arm Description
Intervention with Motor imaginary with video
Arm Title
Non Motor imaginary
Arm Type
Experimental
Arm Description
Intervention with Rest without motor imaginary
Arm Title
tDCS
Arm Type
Experimental
Arm Description
tDCS stimulation during 20 minutes in the motor cortex.
Arm Title
tDCS sham
Arm Type
Sham Comparator
Arm Description
tDCS stimulation during 30 seconds in the motor cortex and then 19 minutes and 30 seconds without any stimulation.
Arm Title
Neurofeedback
Arm Type
Experimental
Arm Description
EEG monitoring in real time with positive feedback in the computer screen when participants motor cortex is activated.
Arm Title
Neurofeedback sham
Arm Type
Sham Comparator
Arm Description
EEG monitoring in real time with randomized feedback in the computer screen despite the motor cortex activation.
Intervention Type
Other
Intervention Name(s)
Motor imaginary
Intervention Description
Participants imagine doing a motor task watching a video recording
Intervention Type
Other
Intervention Name(s)
Non Motor imaginary
Intervention Description
Participants watch a television documentary
Intervention Type
Other
Intervention Name(s)
tDCS
Intervention Description
transcranial direct current stimulation (tDCS) stimulation during 20 minutes in the motor cortex (bilaterally) at 1mA of intensity.
Intervention Type
Other
Intervention Name(s)
tDCS sham
Intervention Description
tDCS stimulation during 30 seconds in the motor cortex (bilaterally) at 1mA of intensity and then 19 minutes and 30 seconds without any stimulation.
Intervention Type
Other
Intervention Name(s)
Neurofeedback
Intervention Description
EEG monitoring of the cerebral cortex in real time with positive feedback in the computer screen when participants motor cortex is activated. The positive feedback consist in an object that moves to the top of the screen when activation occurs in the motor cortex. This task last during 20 minutes.
Intervention Type
Other
Intervention Name(s)
Neurofeedback sham
Intervention Description
EEG monitoring of the cerebral cortex in real time with randomized feedback in the computer screen despite motor cortex activation. The positive feedback consist in an object that moves to the top of the screen in a randomized time. This task last during 20 minutes.
Primary Outcome Measure Information:
Title
Time
Description
Minutes of time when the task is learned
Time Frame
immediately during the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 29 years old Asymptomatic Exclusion Criteria: Subjects with pain In medical treatment Diagnosed of any disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Muñoz, PhD
Phone
91401970
Ext
309
Email
daniel.munoz@lasallecampus.es
Facility Information:
Facility Name
Centro Superior de Estudios Universitarios La Salle
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Muñoz
Phone
689049424
Email
daniel.munoz@lasallecampus.es
First Name & Middle Initial & Last Name & Degree
Daniel Muñoz-Garcia, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33101530
Citation
Serrano JI, Munoz-Garcia D, Ferrer-Pena R, D'eudeville V, Brero M, Boisson M, Del Castillo MD. Prior cortical activity differences during an action observation plus motor imagery task related to motor adaptation performance of a coordinated multi-limb complex task. Cogn Neurodyn. 2020 Dec;14(6):769-779. doi: 10.1007/s11571-020-09633-2. Epub 2020 Sep 10.
Results Reference
derived

Learn more about this trial

Complex Motor Learning With Motor Imaginary

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