NCT03786185

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

August 2, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

6.4 years

First QC Date

December 20, 2018

Last Update Submit

February 29, 2024

Conditions

Keywords

NeuroplasticityComputerized trainingMusic readingMultisensory training

Outcome Measures

Primary Outcomes (2)

  • Change in current density strength of the cortical activity as measured via EEG

    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

    1 month

  • Change in cortical connectivity as measured via EEG

    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.

    1 month

Secondary Outcomes (2)

  • Change in audiovisual integration functionality

    1 month

  • Change in cognitive functionality

    1 month

Study Arms (5)

Adolescents with dyslexia

EXPERIMENTAL

MusicPlast training

Behavioral: MusicPlast

Adolescents without dyslexia

ACTIVE COMPARATOR

MusicPlast training

Behavioral: MusicPlast

Young Adults

EXPERIMENTAL

MusicPlast training

Behavioral: MusicPlast

Young Adults Control

ACTIVE COMPARATOR

MusicPlast Control, in a similar design as MusicPlast

Behavioral: MusicPlast Control

Seniors

EXPERIMENTAL

MusicPlast training

Behavioral: MusicPlast

Interventions

MusicPlastBEHAVIORAL

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.

Adolescents with dyslexiaAdolescents without dyslexiaSeniorsYoung Adults

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.

Young Adults Control

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • years of age
  • normal or corrected-to-normal hearing and vision
  • (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
  • years of age
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Medical Physics

Thessaloniki, 54124, Greece

RECRUITING

Related Publications (3)

  • Paraskevopoulos E, Kraneburg A, Herholz SC, Bamidis PD, Pantev C. Musical expertise is related to altered functional connectivity during audiovisual integration. Proc Natl Acad Sci U S A. 2015 Oct 6;112(40):12522-7. doi: 10.1073/pnas.1510662112. Epub 2015 Sep 14.

    PMID: 26371305BACKGROUND
  • Paraskevopoulos E, Kuchenbuch A, Herholz SC, Pantev C. Multisensory integration during short-term music reading training enhances both uni- and multisensory cortical processing. J Cogn Neurosci. 2014 Oct;26(10):2224-38. doi: 10.1162/jocn_a_00620. Epub 2014 Mar 26.

    PMID: 24669793BACKGROUND
  • Paraskevopoulos E, Kuchenbuch A, Herholz SC, Pantev C. Musical expertise induces audiovisual integration of abstract congruency rules. J Neurosci. 2012 Dec 12;32(50):18196-203. doi: 10.1523/JNEUROSCI.1947-12.2012.

    PMID: 23238733BACKGROUND

Related Links

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Evangelos Paraskevopoulos, PhD

    Research Associate

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evangelos Paraskevopoulos, PhD

CONTACT

Nikolaos Chalas

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant is not aware of the group (intervention or control) in which s/he belongs.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 24, 2018

Study Start

August 2, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations