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Neurofeedback Training for Dyslexia

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04989088
Collaborator
University of Milan (Other)
40
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ProComp5 Infiniti System w/BioGraph Infiniti Software
  • Device: ProComp5 Infiniti System w/recorded videos
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Neurofeedback Training to Restore Hemispheric Imbalance in Dyslexia
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Left theta/beta and right beta/theta NF training

Device: ProComp5 Infiniti System w/BioGraph Infiniti Software
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)
Placebo Comparator: Sham NF training

Device: ProComp5 Infiniti System w/recorded videos
Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)

Outcome Measures

Primary Outcome Measures

  1. EEG recording - ProComp5 Infiniti System [1 hour]

    EEG power in theta/beta band recording in TP7 and TP8

  2. Phonological task (Spironelli & Angrilli, 2006) accuracy [1 hour]

    Computerized rhyme decision task - n. of errors

  3. Phonological task (Spironelli & Angrilli, 2006) speed [1 hour]

    Computerized rhyme decision task - response time (ms)

  4. Semantic task (Spironelli & Angrilli, 2006) speed [1 hour]

    Computerized semantic decision task - response time (ms)

  5. Semantic task (Spironelli & Angrilli, 2006) accuracy [1 hour]

    Computerized semantic decision task - n. of errors

  6. Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) [1 hour]

    Text reading speed measured in syllables / seconds

  7. Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) [1 hour]

    Text reading accuracy measured in n. of errors

  8. Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) [1 hour]

    Word reading speed measured in syllables / seconds

  9. Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) [1 hour]

    Word reading accuracy measured in n. of errors

  10. Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) [1 hour]

    Psuedo-word reading speed in syllables / seconds

  11. Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) [1 hour]

    Psuedo-word reading accuracy measured in n. of errors

Secondary Outcome Measures

  1. Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005) [1 hour]

    Rapid automatized naming (RAN) speed measured in seconds

  2. Rapid automatized naming accuracy (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005) [1 hour]

    Rapid automatized naming (RAN) accuracy measures in n. of errors

  3. Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV) [1 hour]

    Digit forward and digit backword task

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Catholic University of the Sacred Heart
  • University of Milan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alice Cancer, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT04989088
Other Study ID Numbers:
  • NF-DYSL
First Posted:
Aug 4, 2021
Last Update Posted:
Aug 4, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Dyslexia

Study Results

No Results Posted as of Aug 4, 2021