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Neurofeedback Training for Dyslexia

Primary Purpose

Dyslexia, Reading Problem

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProComp5 Infiniti System w/BioGraph Infiniti Software
ProComp5 Infiniti System w/recorded videos
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslexia

Eligibility Criteria

8 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of dyslexia or reading performance 2 SD below the norm
  • Average intelligence

Exclusion Criteria:

  • Psychiatric conditions
  • Comorbidity with neurodevelopmental disorders
  • Neurological disorders
  • Epilepsy
  • Enrollment in linguistic or literature university courses

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Left theta/beta and right beta/theta NF training

    Sham NF training

    Arm Description

    Outcomes

    Primary Outcome Measures

    EEG recording - ProComp5 Infiniti System
    EEG power in theta/beta band recording in TP7 and TP8
    Phonological task (Spironelli & Angrilli, 2006) accuracy
    Computerized rhyme decision task - n. of errors
    Phonological task (Spironelli & Angrilli, 2006) speed
    Computerized rhyme decision task - response time (ms)
    Semantic task (Spironelli & Angrilli, 2006) speed
    Computerized semantic decision task - response time (ms)
    Semantic task (Spironelli & Angrilli, 2006) accuracy
    Computerized semantic decision task - n. of errors
    Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Text reading speed measured in syllables / seconds
    Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Text reading accuracy measured in n. of errors
    Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Word reading speed measured in syllables / seconds
    Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Word reading accuracy measured in n. of errors
    Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Psuedo-word reading speed in syllables / seconds
    Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Psuedo-word reading accuracy measured in n. of errors

    Secondary Outcome Measures

    Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
    Rapid automatized naming (RAN) speed measured in seconds
    Rapid automatized naming accuracy (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
    Rapid automatized naming (RAN) accuracy measures in n. of errors
    Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV)
    Digit forward and digit backword task

    Full Information

    First Posted
    July 15, 2021
    Last Updated
    July 24, 2021
    Sponsor
    Catholic University of the Sacred Heart
    Collaborators
    University of Milan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04989088
    Brief Title
    Neurofeedback Training for Dyslexia
    Official Title
    Neurofeedback Training to Restore Hemispheric Imbalance in Dyslexia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Catholic University of the Sacred Heart
    Collaborators
    University of Milan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aims at testing a Neurofeedback (NF) training specifically designed for inducing a functional hemispheric imbalance of the tempo-parietal regions in individuals with dyslexia. A randomized clinical trial aimed at comparing two experimental conditions is described: a) Left theta/beta NF training in combination with right beta/theta NF training and b) sham NF training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslexia, Reading Problem

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Left theta/beta and right beta/theta NF training
    Arm Type
    Experimental
    Arm Title
    Sham NF training
    Arm Type
    Placebo Comparator
    Intervention Type
    Device
    Intervention Name(s)
    ProComp5 Infiniti System w/BioGraph Infiniti Software
    Intervention Description
    Left theta/beta NF training in combination with right beta/theta NF training in temporo-parietal regions, for 40 minutes (with a 20-minute break period)
    Intervention Type
    Device
    Intervention Name(s)
    ProComp5 Infiniti System w/recorded videos
    Intervention Description
    Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)
    Primary Outcome Measure Information:
    Title
    EEG recording - ProComp5 Infiniti System
    Description
    EEG power in theta/beta band recording in TP7 and TP8
    Time Frame
    1 hour
    Title
    Phonological task (Spironelli & Angrilli, 2006) accuracy
    Description
    Computerized rhyme decision task - n. of errors
    Time Frame
    1 hour
    Title
    Phonological task (Spironelli & Angrilli, 2006) speed
    Description
    Computerized rhyme decision task - response time (ms)
    Time Frame
    1 hour
    Title
    Semantic task (Spironelli & Angrilli, 2006) speed
    Description
    Computerized semantic decision task - response time (ms)
    Time Frame
    1 hour
    Title
    Semantic task (Spironelli & Angrilli, 2006) accuracy
    Description
    Computerized semantic decision task - n. of errors
    Time Frame
    1 hour
    Title
    Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Description
    Text reading speed measured in syllables / seconds
    Time Frame
    1 hour
    Title
    Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Description
    Text reading accuracy measured in n. of errors
    Time Frame
    1 hour
    Title
    Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Description
    Word reading speed measured in syllables / seconds
    Time Frame
    1 hour
    Title
    Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Description
    Word reading accuracy measured in n. of errors
    Time Frame
    1 hour
    Title
    Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Description
    Psuedo-word reading speed in syllables / seconds
    Time Frame
    1 hour
    Title
    Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
    Description
    Psuedo-word reading accuracy measured in n. of errors
    Time Frame
    1 hour
    Secondary Outcome Measure Information:
    Title
    Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
    Description
    Rapid automatized naming (RAN) speed measured in seconds
    Time Frame
    1 hour
    Title
    Rapid automatized naming accuracy (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
    Description
    Rapid automatized naming (RAN) accuracy measures in n. of errors
    Time Frame
    1 hour
    Title
    Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV)
    Description
    Digit forward and digit backword task
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of dyslexia or reading performance 2 SD below the norm Average intelligence Exclusion Criteria: Psychiatric conditions Comorbidity with neurodevelopmental disorders Neurological disorders Epilepsy Enrollment in linguistic or literature university courses
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alice Cancer, PhD
    Phone
    0272342284
    Email
    alice.cancer@unicatt.it

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    34803851
    Citation
    Cancer A, Vanutelli ME, Lucchiari C, Antonietti A. Using Neurofeedback to Restore Inter-Hemispheric Imbalance: A Study Protocol for Adults With Dyslexia. Front Psychol. 2021 Nov 5;12:768061. doi: 10.3389/fpsyg.2021.768061. eCollection 2021.
    Results Reference
    derived

    Learn more about this trial

    Neurofeedback Training for Dyslexia

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