Neurofeedback Training for Dyslexia

Study Overview
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Brief Summary
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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.

Official Title
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Neurofeedback Training to Restore Hemispheric Imbalance in Dyslexia

Conditions
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Dyslexia, Reading Problem

Intervention / Treatment
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* Device: ProComp5 Infiniti System w/BioGraph Infiniti Software
* Device: ProComp5 Infiniti System w/recorded videos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left theta/beta and right beta/theta NF training<br> | Device: ProComp5 Infiniti System w/BioGraph Infiniti Software<br>* 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)<br>|
| Placebo Comparator: Sham NF training<br> | Device: ProComp5 Infiniti System w/recorded videos<br>* Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG recording - ProComp5 Infiniti System | EEG power in theta/beta band recording in TP7 and TP8 | 1 hour | 
| Phonological task (Spironelli & Angrilli, 2006) accuracy | Computerized rhyme decision task - n. of errors | 1 hour | 
| Phonological task (Spironelli & Angrilli, 2006) speed | Computerized rhyme decision task - response time (ms) | 1 hour | 
| Semantic task (Spironelli & Angrilli, 2006) speed | Computerized semantic decision task - response time (ms) | 1 hour | 
| Semantic task (Spironelli & Angrilli, 2006) accuracy | Computerized semantic decision task - n. of errors | 1 hour | 
| Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) | Text reading speed measured in syllables / seconds | 1 hour | 
| Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) | Text reading accuracy measured in n. of errors | 1 hour | 
| Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) | Word reading speed measured in syllables / seconds | 1 hour | 
| Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) | Word reading accuracy measured in n. of errors | 1 hour | 
| Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) | Psuedo-word reading speed in syllables / seconds | 1 hour | 
| Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020) | Psuedo-word reading accuracy measured in n. of errors | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005) | Rapid automatized naming (RAN) speed measured in seconds | 1 hour | 
| Rapid automatized naming accuracy (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005) | Rapid automatized naming (RAN) accuracy measures in n. of errors | 1 hour | 
| Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV) | Digit forward and digit backword task | 1 hour |