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Trial details
Effects of different mental training techniques on fine motor performance.
Current status:
Approved
|
Date registered:
18/06/2021
|
Date last updated:
16/06/2021
Trial version(s)
Current: 29/05/2021
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Main Information
Primary registry identifying number
LBCTR2021054816
Protocol number
CEHDF 1787
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
28/05/2021
Primary sponsor
Saint Joseph University of Beirut
Primary sponsor: Country of origin
Lebanon
Public title
Effects of different mental training techniques on fine motor performance.
Acronym
Scientific title
Comparison between the effects of Neurofeedback training and Motor imagery training on motor performance in a finger tapping task.
Acronym
Brief summary of the study: English
Motor Imagery (MI) refers to the act of imagining a specific action without actually executing it (Decety et al., 1994). This ability for humans to mentally rehearse a movement has been extensively documented due to its benefits in both sport and clinical contexts (Schuster et al. 2011; Guillot, 2019). EEG-Neurofeedback (EEG-NF), is also a type of mental training that teaches self-control of brain activity by measuring brain waves and providing a feedback signal. Through the EEG-NF process, a person can learn to modulate its own neuronal activity. Ros et al. (2010) observed an increase in corticospinal excitability in the primary motor cortex following a 30-minute session of mu wave desynchronization training with EEG-NF. Moreover, Ros et al. (2014), showed that an EEG-NF training of 30 minutes aiming to induce desynchronization of mu brain wave leads to better implicit motor learning of a sequential motor task. The main aim of this study is to elucidate the effect of desynchronization of mu brain wave in the primary motor cortex through EEG-NF training on explicit sequential motor performance in healthy humans. We will also compare the effects of EEG-NF training to those of MI training which has already proven its efficiency. Finally, we aim to see if the association of those two trainings would be more beneficial.
Brief summary of the study: Arabic
التصور الحركي هو القدرة على تخييل حركة معينة دون تنفيذها فعلياً (Decety et al., 1994). تم توثيق قدرة البشر على التصور الحركي على نطاق واسع نظرًا لفوائد هذه التقنية في مجال الرياضة وإعادة تأهيل الحركة (Schuster et al. 2011; Guillot, 2019).. الإرتجاع العصبي يشكل نوع أخر من التدريب الذهني. تهدف تقنية الارتجاع العصبي إلى تزويد الفرد بمعلومات عن نشاط دماغه في الوقت الفعلي. يتعلم الشخص ، المطلع على حالته الذهنية ، السيطرة عليها تدريجياً. هذا قد يسمح بتحسين الأداء المعرفي أو الحركي. روس (Ros et al. 2010) أثبت أن تقنية الإرتجاع العصبي وتحديداً التمرن لمدة ٣٠ دقيقة على زيادة النشاط في المنطقة الذهنية المسؤولة عن الحركة يؤدي إلى استثارة الخلايا العصبية. في دراسة أخرى، يظهر روس (Ros et al. 2014) أن التمرين نفسه خلال تقنية الإرتجاع العصبي، يؤدي إلى تحسين تعلم حركة جديدة بشكل غير مباشر. يهدف هذا البحث لإثبات دور تقنية الإرتجاع العصبي وتحديداً التمرين على زيادة الاستثارة العصبية في المنطقة الذهنة المسؤولة عن الحركة على الأداء الحركي المباشر. بالإضافة إلى ذلك يهدف هذا البحث إلى المقارنة بين فعالية الإرتجاع العصبي والتصور الحركي،التي اثبتت فعاليتها، على تطور الحركة. أخيراً يهدف هذا البحث إلى دراسة تأثير دمج التقنياتان على الحركة.
Health conditions/problem studied: Specify
This study is conducted with healthy adult volunteers and could help enhance their motor skills. If the EEG-NF technique proves to be beneficial in explicit motor performance it could be eventually applied in the context of pathologies.
Interventions: Specify
Intervention 1: EEG-Neurofeedback (30 minutes of training to desynchronize the mu band in the C4 area) Intervention 2: Motor Imagery (30 minutes of imagination of movement) Intervention 3: Motor imagery training, EEG-Neurofeedback (30 minutes alternated training) Intervention 4: Control group (placebo/sham)
Key inclusion and exclusion criteria: Inclusion criteria
-Healthy adults (aged between 18 and 40 y.o.) - right handed
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
40
Key inclusion and exclusion criteria: Exclusion criteria
-Any neurological disorder -Humor disorders
Type of Study
Type
Interventional
Type of intervention
Rehabilitation strategies
Trial scope
Other
Trial scope: Specify scope
Fine motor skill improvement
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Placebo
Study phase
N/A
Study design: Purpose
Supportive care
Study design: Assignment
Parallel
Pharmaceutical class
NA
Therapeutic indication
The training suggested, if proved to be beneficial, could be eventually applied in the context of motor rehabilitation.
Therapeutic benefit
The suggested trainings could lead to the improvement of motor skills
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
60
Actual enrollment target size
60
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/06/2021
Date of study closure: Type
Anticipated
Date of study closure: Date
01/07/2022
Recruitment status
Recruiting
Date of completion
01/07/2022
IPD sharing statement plan
Yes
IPD sharing statement description
1. Individual participant data will be available. 2. Individual participant data that underlie the results reported in the article, will be shared after deidentification. 3. Study protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code will be available. 4. The above data will be shared with researchers who provide a methodologically sound proposal. 5. Sharing data could be done for any purpose of analyses. 6. Proposals should be directed to sandra.kobaitermaarrawi@usj.edu.lb. To gain access, data requestors will need to sign a data access agreement. Proposals may be submitted up to 36 months following article publication. After that time, data will be available in our university Lab database.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Not Applicable
Not Applicable
Sources of Monetary or Material Support
Name
Saint Joseph University of Beirut - Faculty of Medicine - Research council
Secondary Sponsors
Name
Not Applicable
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Sandra
Kobaiter Maarrawi
USJ
Lebanon
01421677
sandra.kobaitermaarrawi@usj.edu.lb
USJ - FM
Scientific
Sandra
Kobaiter Maarrawi
USJ
Lebanon
01421677
sandra.kobaitermaarrawi@usj.edu.lb
USJ - FM
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Laboratory of Research in Neuroscience
Sandra Kobaiter Maarrawi
Neuroscience
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
08/03/2021
Pr Michel Scheuer
michel.scheuer@usj.edu.lb
01421000 ext 2228
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Motor skills
2-Propanol (T51.2)
Motor skills
Interventions
Intervention
Description
Keyword
Mental (motor) imagery
the act of imagining a specific action without actually executing it
Motor imagery
Neurofeedback
mental training that teaches self-control of brain activity by measuring brain waves and providing a feedback signal
Neurofeedback
Placebo
sham condition
Placebo
Primary Outcomes
Name
Time points
Measure
The number of sequences correctly executed throughout training blocks
Immediately after training
keyboard press task
The average time needed to complete a correct sequence throughout training blocks
Immediately after training
keyboard press task
Key Secondary Outcomes
Name
Time points
Measure
Motor Performance
20 minutes after training/24h after training
keyboard press task
Percentage of Event related desynchronization
during training
Procomp infiniti EEG-Neurofeedback machine
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial