NCT02999516

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 24, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

November 24, 2016

Last Update Submit

July 30, 2018

Conditions

Learning Disturbance

Outcome Measures

Primary Outcomes (1)

  • Time

    Minutes of time when the task is learned

    immediately during the intervention

Study Arms (6)

Motor imaginary

EXPERIMENTAL

Intervention with Motor imaginary with video

Other: Motor imaginary

Non Motor imaginary

EXPERIMENTAL

Intervention with Rest without motor imaginary

Other: Non Motor imaginary

tDCS

EXPERIMENTAL

tDCS stimulation during 20 minutes in the motor cortex.

Other: tDCS

tDCS sham

SHAM COMPARATOR

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

Other: tDCS sham

Neurofeedback

EXPERIMENTAL

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

Other: Neurofeedback

Neurofeedback sham

SHAM COMPARATOR

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

Other: Neurofeedback sham

Interventions

Motor imaginaryOTHER

Participants imagine doing a motor task watching a video recording

Motor imaginary
Non Motor imaginaryOTHER

Participants watch a television documentary

Non Motor imaginary
tDCSOTHER

transcranial direct current stimulation (tDCS) stimulation during 20 minutes in the motor cortex (bilaterally) at 1mA of intensity.

tDCS
tDCS shamOTHER

tDCS stimulation during 30 seconds in the motor cortex (bilaterally) at 1mA of intensity and then 19 minutes and 30 seconds without any stimulation.

tDCS sham
NeurofeedbackOTHER

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.

Neurofeedback
Neurofeedback shamOTHER

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.

Neurofeedback sham

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 29 years old
  • Asymptomatic

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Superior de Estudios Universitarios La Salle

Madrid, 28660, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33101530DERIVED

MeSH Terms

Conditions

Learning Disabilities

Interventions

Transcranial Direct Current StimulationNeurofeedback

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesBiofeedback, PsychologyMind-Body TherapiesComplementary TherapiesBehavior TherapyPsychotherapyFeedback, Psychological

Central Study Contacts

Daniel Muñoz, PhD

CONTACT

91401970daniel.munoz@lasallecampus.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 24, 2016

First Posted

December 21, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

ES(1)