Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroplasticity of Multisensory Cortical Areas Induced by Musical Training: a Translational Approach (MusicPlast) (MusicPlast)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03786185
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Panos Bamidis, Aristotle University Of Thessaloniki

Brief Summary:

Exploiting recent methodological advancements, several neuroimaging studies suggested that multisensory integration emerges from a dynamic interplay of distributed regions operating in large-scale networks. Nonetheless, the cortical structures and neuronal networks underlying the development of multisensory perception and plasticity, throughout the life span, have not yet been studied in detail. A special case of multisensory training is musical training, which utilizes stimulus' structural complexity, as well as the emotional drive that music is generating to the subjects, in order to induce augmented neuroplastic effects.

Retaining the extensive neuroplastic characteristics of music training, MUSICPLAST will develop, investigate and deliver a computer provided multisensory training protocol that aims to induce neuroplastic changes in frontotemporal cortical areas. More specifically, the goal of the proposed project is threefold: (a) The in-depth understanding and modeling of the developmental trajectory of the cortical networks underlying multisensory perception, (b) the modeling of the developmental trajectory of the cortical networks underlying multisensory plasticity throughout the life span of healthy subjects; and (c) the translation of this model in a computer provided multisensory training intervention protocol, which will cause beneficial neuroplastic changes in pathological populations. Electroencephalographic, behavioral and neuropsychological measurements, and advanced data analysis procedures, pre- and post the training application are going to be employed in order to evaluate the resulting neuroplasticity holistically. The proposed protocol will also be translated into an applied intervention for 2 groups of pathological population, for which there are strong evidence that a multisensory cognitive training based on music may provide beneficial neuroplastic changes: elderlies suffering from mild cognitive Impairment and adolescents with dyslexia.

The project is performed in the Laboratory of Medical Physics of the Aristotle University of Thessaloniki. It takes advantage of the extensive background of the laboratory in music and neuroscience, in multisensory perception and in applications that translate basic neuroscientific knowledge into computer based interventions for young adults and elderlies, building up a solid neuroscientific ground on which multidisciplinary characteristics of the project stand.


Condition or disease Intervention/treatment Phase
Dyslexia Aging Problems Behavioral: MusicPlast Behavioral: MusicPlast Control Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a 2x2x2 mixed model design with between subjects factors condition (congruent and incongruent) and age group (adolescent, adults, elderlies) and within subjects factor time (pre, post).
Masking: Single (Participant)
Masking Description: The participant is not aware of the group (intervention or control) in which s/he belongs.
Primary Purpose: Treatment
Official Title: Neuroplasticity of Multisensory Cortical Areas Induced by Computerized Musical Training, Across the Life Span: a Translational Approach
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Arm Intervention/treatment
Experimental: Adolescents with dyslexia
MusicPlast training
Behavioral: MusicPlast
Each subject will receive 20 sessions of the computerized training based on a simplified music reading protocol. The training will be provided via a smartphone or a tablet. Each training session will last for 20 minutes and the log file will be directly available to the researcher, allowing him/her to follow subject's timely participation. The stimuli used in the training protocol will consist of a visual image showing a circle on top of a background of 5 horizontal lines. The auditory part of the stimulus will consist of piano melodies of known songs. The position of the circle within the five lines will either follow the rule "the higher the pitch of the tone, the higher the position of the circle" or it will violate the above rule. The task requires audiovisual integration.

Active Comparator: Adolescents without dyslexia
MusicPlast training
Behavioral: MusicPlast
Each subject will receive 20 sessions of the computerized training based on a simplified music reading protocol. The training will be provided via a smartphone or a tablet. Each training session will last for 20 minutes and the log file will be directly available to the researcher, allowing him/her to follow subject's timely participation. The stimuli used in the training protocol will consist of a visual image showing a circle on top of a background of 5 horizontal lines. The auditory part of the stimulus will consist of piano melodies of known songs. The position of the circle within the five lines will either follow the rule "the higher the pitch of the tone, the higher the position of the circle" or it will violate the above rule. The task requires audiovisual integration.

Experimental: Young Adults
MusicPlast training
Behavioral: MusicPlast
Each subject will receive 20 sessions of the computerized training based on a simplified music reading protocol. The training will be provided via a smartphone or a tablet. Each training session will last for 20 minutes and the log file will be directly available to the researcher, allowing him/her to follow subject's timely participation. The stimuli used in the training protocol will consist of a visual image showing a circle on top of a background of 5 horizontal lines. The auditory part of the stimulus will consist of piano melodies of known songs. The position of the circle within the five lines will either follow the rule "the higher the pitch of the tone, the higher the position of the circle" or it will violate the above rule. The task requires audiovisual integration.

Active Comparator: Young Adults Control
MusicPlast Control, in a similar design as MusicPlast
Behavioral: MusicPlast Control
Each subject will receive 20 sessions of the computerized training within a period of 4 weeks, aiming to train visual search via spot-the-difference tasks and identification of dissonance in music. Auditory and visual stimuli are concurrently presented, but do not require audiovisual integration.

Experimental: Seniors
MusicPlast training
Behavioral: MusicPlast
Each subject will receive 20 sessions of the computerized training based on a simplified music reading protocol. The training will be provided via a smartphone or a tablet. Each training session will last for 20 minutes and the log file will be directly available to the researcher, allowing him/her to follow subject's timely participation. The stimuli used in the training protocol will consist of a visual image showing a circle on top of a background of 5 horizontal lines. The auditory part of the stimulus will consist of piano melodies of known songs. The position of the circle within the five lines will either follow the rule "the higher the pitch of the tone, the higher the position of the circle" or it will violate the above rule. The task requires audiovisual integration.




Primary Outcome Measures :
  1. Change in current density strength of the cortical activity as measured via EEG [ Time Frame: 1 month ]
    Changes in cortical activity strength caused via the training. Change is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high density EEG recordings, before compared to after the training

  2. Change in cortical connectivity as measured via EEG [ Time Frame: 1 month ]
    Changes in cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of the Transfer Entropy estimated from the cortical activity, as reconstructed via LORETA algorithm on the basis of high density EEG recordings, before compared to after the training.


Secondary Outcome Measures :
  1. Change in audiovisual integration functionality [ Time Frame: 1 month ]
    Change of accuracy in the behavioral measurement testing audiovisual integration. Change is defined as statistical significance in the t-test comparison before compared to after the training.

  2. Change in cognitive functionality [ Time Frame: 1 month ]
    Change of scoring in neuropsychological tests related with attention, memory and performance. Change is defined as statistical significance in the t-test comparison before compared to after the training.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Group of Adolescent dyslectics

Inclusion Criteria:

  • 13 - 18 years of age
  • normal or corrected-to-normal hearing and vision
  • Diagnosed dyslexia

Exclusion Criteria:

  • any other than dyslexia, diagnosed neurological, mental, developmental or psychiatric disorder
  • (ii) unrecovered neurological disorders (i.e., stroke, traumatic brain injury),
  • (iii) unstable medication within the last 3 months,
  • (iv) severe physical disorder, and
  • (v) concurrent participation in another relevant study.

Group of Adolescent controls

Inclusion Criteria:

  • 13 - 18 years of age
  • normal or corrected-to-normal hearing and vision

Exclusion Criteria:

  • (I) any diagnosed neurological, mental, developmental or psychiatric disorder
  • (ii) unrecovered neurological disorders (i.e., stroke, traumatic brain injury),
  • (iii) unstable medication within the last 3 months,
  • (iv) severe physical disorder, and
  • (v) concurrent participation in another relevant study.

Group of Young Adults

Inclusion Criteria:

  • 18 - 35 years of age
  • normal or corrected-to-normal hearing and vision

Exclusion Criteria:

  • (I) any diagnosed neurological, mental, developmental or psychiatric disorder
  • (ii) unrecovered neurological disorders (i.e., stroke, traumatic brain injury),
  • (iii) unstable medication within the last 3 months,
  • (iv) severe physical disorder, and
  • (v) concurrent participation in another relevant study.

Group of Seniors

Inclusion Criteria:

  • 65 - 100 years of age
  • normal or corrected-to-normal hearing and vision
  • normal score in a neuropsychological screening procedure which regards cognitive functionality

Exclusion Criteria:

  • (i) unrecovered neurological disorders (i.e., stroke, traumatic brain injury),
  • (ii) severe depression or psychological disorder,
  • (iii) unstable medication within the last 3 months,
  • (iv) severe physical disorder, and
  • (v) concurrent participation in another relevant study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786185


Contacts
Layout table for location contacts
Contact: Evangelos Paraskevopoulos, PhD +306944141615 parasvag@auth.gr
Contact: Nikolaos Chalas +306981505249 nichalas@auth.gr

Locations
Layout table for location information
Greece
Laboratory of Medical Physics Recruiting
Thessaloníki, Greece, 54124
Contact: Evangelos Paraskevopoulos, PhD    +306944141615    parasvag@auth.gr   
Principal Investigator: Evangelos Paraskevopoulos, PhD         
Sub-Investigator: Panagiotis Bamidis, PhD         
Sub-Investigator: Nikolaos Chalas         
Sub-Investigator: Maria Karagianni, MSc         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Layout table for investigator information
Principal Investigator: Evangelos Paraskevopoulos, PhD Research Associate

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Panos Bamidis, Associate Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03786185     History of Changes
Other Study ID Numbers: 2089
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual Participant Data (IPD) will be available upon the completion of the study via personal communication. Data shared will include EEG measurements, score on behavioral and psychometric data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Panos Bamidis, Aristotle University Of Thessaloniki:
Neuroplasticity
Computerized training
Music reading
Multisensory training
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyslexia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders