Learning DisturbanceNCT02999516
Complex Motor Learning With Motor Imaginary
A study testing Motor imaginary, Non Motor imaginary and tDCS in people with Learning Disturbance, run by Centro Universitario La Salle at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Disturbance
- What is being tested?
- Motor imaginary, Non Motor imaginary and tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 29 years old
- Asymptomatic
Who cannot join
- Subjects with pain
- In medical treatment
- Diagnosed of any disease
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centro Superior de Estudios Universitarios La Salle
Madrid, 28660
Daniel Muñoz, 689049424, daniel.munoz@lasallecampus.es
Daniel Muñoz-Garcia, PhD
About this study
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.
Read the 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.
- Conditions
- Learning Disturbance
- Being tested
- Motor imaginary, Non Motor imaginary, tDCS, tDCS sham, Neurofeedback
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imaginaryOther
Participants imagine doing a motor task watching a video recording
Non Motor imaginaryOther
Participants watch a television documentary
tDCSOther
transcranial direct current stimulation (tDCS) stimulation during 20 minutes in the motor cortex (bilaterally) at 1mA of intensity.
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.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Motor imaginary | Experimental | Intervention with Motor imaginary with video Receives: Other: Motor imaginary |
| Non Motor imaginary | Experimental | Intervention with Rest without motor imaginary Receives: Other: Non Motor imaginary |
| tDCS | Experimental | tDCS stimulation during 20 minutes in the motor cortex. Receives: 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. Receives: Other: tDCS sham |
| Neurofeedback | Experimental | EEG monitoring in real time with positive feedback in the computer screen when participants motor cortex is activated. Receives: Other: Neurofeedback |
| Neurofeedback sham | Sham comparator | EEG monitoring in real time with randomized feedback in the computer screen despite the motor cortex activation. Receives: Other: Neurofeedback sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Minutes of time when the task is learned
Measured: immediately during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Learning DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Muñoz-Garcia, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999516
- Sponsor's protocol ID
- CULaSalle
- Status last verified
- Jul 2018
- First submitted
- 24 Nov 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33101530
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Motor Learning With Motor Imaginary
- ClinicalTrials.gov ID
- NCT02999516
- Acronym / sponsor ID
- CULaSalle
- Conditions
- Learning Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Motor imaginary | Experimental | Other: Motor imaginaryIntervention with Motor imaginary with video |
| Non Motor imaginary | Experimental | Other: Non Motor imaginaryIntervention with Rest without motor imaginary |
| tDCS | Experimental | Other: tDCStDCS stimulation during 20 minutes in the motor cortex. |
| tDCS sham | Sham comparator | Other: tDCS shamtDCS stimulation during 30 seconds in the motor cortex and then 19 minutes and 30 seconds without any stimulation. |
| Neurofeedback | Experimental | Other: NeurofeedbackEEG monitoring in real time with positive feedback in the computer screen when participants motor cortex is activated. |
| Neurofeedback sham | Sham comparator | Other: Neurofeedback shamEEG monitoring in real time with randomized feedback in the computer screen despite the motor cortex activation. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 29 years old
- Asymptomatic
Key exclusion criteria (3 listed)
- Subjects with pain
- In medical treatment
- Diagnosed of any disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor imaginaryParticipants imagine doing a motor task watching a video recording | Other | Motor imaginary |
| Non Motor imaginaryParticipants watch a television documentary | Other | Non Motor imaginary |
| tDCStranscranial direct current stimulation (tDCS) stimulation during 20 minutes in the motor cortex (bilaterally) at 1mA of intensity. | Other | tDCS |
| tDCS shamtDCS stimulation during 30 seconds in the motor cortex (bilaterally) at 1mA of intensity and then 19 minutes and 30 seconds without any stimulation. | Other | tDCS sham |
| NeurofeedbackEEG 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. | Other | Neurofeedback |
| Neurofeedback shamEEG 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. | Other | Neurofeedback sham |
Primary outcome
Time
Time frame: immediately during the intervention
Minutes of time when the task is learned
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 33101530Serrano 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imaginary, Non Motor imaginary and tDCS in people with Learning Disturbance, run by Centro Universitario La Salle at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Muñoz, PhD (91401970 ext. 309, daniel.munoz@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: immediately during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.